Phosphoric acid, (1-methylethylidene) di-4,1-phenylene tetraphenyl ester (Fyrolflex BDP)
File No: NA/773
1 November 2000
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
Phosphoric acid, (1-methylethylidene) di-4,1-phenylene tetraphenyl ester
(Fyrolflex BDP)
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) and Regulations. This legislation is an Act of the
Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) is administered by the National Occupational Health and Safety Commission
which also conducts the occupational health & safety assessment. The assessment of environmental
hazard is conducted by the Department of the Environment and the assessment of public health is
conducted by the Department of Health and Aged Care.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be inspected by
the public at the Library, National Occupational Health and Safety Commission, 92-94 Parramatta
Road, Camperdown NSW 2050, between the following hours:
Monday - Wednesday 8.30 am - 5.00 pm
Thursday 8.30 am - 8.00 pm
Friday 8.30 am - 5.00 pm
Copies of this full public report may also be requested, free of charge, by contacting the
Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone: (61) (02) 9577 9514 FAX (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
NA/773
FULL PUBLIC REPORT
Phosphoric acid, (1-methylethylidene) di-4,1-phenylene tetraphenyl ester
(Fyrolflex BDP)
1. APPLICANT
Akzo Nobel Chemicals Pty Ltd of Grand Avenue CAMELLIA NSW 2142 and General
Electric Plastics (Australia) Pty Ltd of 175 Hammond Road DANDENONG VIC 3175 have
jointly submitted a standard notification statement in support of their application for an
assessment certificate for Phosphoric acid, (1-methylethylidene) di-4,1-phenylene tetraphenyl
ester (Fyrolflex BDP).
The joint notifiers have not requested any information relating to the notified chemical to be
exempt from publication in the Full Public Report and Summary Report.
2. IDENTITY OF THE CHEMICAL
Chemical Name: Phosphoric acid, (1-methylethylidene) di-4,1-phenylene
tetraphenyl ester
Chemical Abstracts Service 5945-33-5
(CAS) Registry No.:
Other Names: Bisphenol A bis(diphenyl phosphate) (BPA-BDPP)
4,4'-(Isopropylidenediphenyl) bis(diphenyl phosphate)
Tetraphenyl bisphenol A biphosphate
Marketing Name: Fyrolflex BDP (commercial form containing 88.1% of
the notified chemical)
Molecular Formula: C39H34O8P2
FULL PUBLIC REPORT 1 November, 2000
NA/773 2/28
Structural Formula:
O
CH3
O
O P O
C
O P O
O
CH3
O
X
X = 0, Triphenyl phosphate
X = 1, Major component of new chemical (85%)
X = 2, 3, 4 , Higher oligomers
Molecular Weight: 693.25 (dimer or P2 where x = 1)
Method of Detection UV/visible spectrum, Infrared (IR) spectrum, Nuclear
and Determination: Magnetic Resonance (NMR), Mass spectrum
Spectral Data: IR major characteristic peaks observed at 571, 666, 750,
768, 777, 843, 969, 1 008, 1 026, 1 188, 1 192, 1 294,
1 492, 1 503 and 1 591cm-1
Comments on Chemical Identity
The new chemical is a mixture of low molecular weight resin phosphate esters, the general
structures of which are depicted above. The molecular weight supplied by the notifier
(693.2 g/mol) applies strictly to the major component which is the moiety with X = 1 in the
general structural formula. This component comprises 85% of the new chemical, with the
balance primarily made up of higher oligomers and the impurity triphenyl phosphate.
An IR spectrum for the notified chemical characterises the major functionalities. The notifier
also supplied an UV-visible spectrum and copies of 31P and 13C NMR spectra.
FULL PUBLIC REPORT 1 November, 2000
NA/773 3/28
3. PHYSICAL AND CHEMICAL PROPERTIES
The properties reported below are those of the notified chemical unless otherwise stated.
20癈 colourless to light yellow viscous liquid;
Appearance at
buff solid (imported product containing the notified
and 101.3 kPa:
chemical)
approximately 41 - 69癈; decomposes at approximately
Boiling Point:
201癈
1.2 kg/m3
Density:
< 1.2 x 10-6 kPa at 25癈
Vapour Pressure:
0.0775 kPa at 50癈 (calculated)
0.415 mg/L at 20癈
Water Solubility:
log Pow = > 6 at 25癈
Partition Co-efficient
(n-octanol/water):
T1/2 at pH 4.0: > 1 year at 25癈
Hydrolysis as a Function
T1/2 at pH 7.0: > 1 year at 25癈
of pH:
T1/2 at pH 9.0: > 1 year at 25癈
Log Koc = >4.53
Adsorption/Desorption:
Koc = >3.39 x 104
not determined
Dissociation Constant:
Granular, 2 - 3 mm section and 3 - 5 mm long
Particle Size:
(imported product containing the notified chemical)
> 300癈
Flash Point:
not flammable
Flammability Limits:
none below 400癈
Autoignition Temperature:
not determined
Explosive Properties:
Stable; no oxidising properties
Reactivity/Stability:
Comments on Physico-Chemical Properties
The physico-chemical properties were determined using OECD test methods.
FULL PUBLIC REPORT 1 November, 2000
NA/773 4/28
The melting point was determined by Hogg A S (1997) using differential scanning
calorimetry, and two distinct peaks were observed in the trace between 41.3 and 68.6癈. It is
probable that one peak corresponds to melting of the X = 1 moiety, while the other
corresponds to melting of the higher oligomers. The compound decomposes without boiling
at temperatures above 201癈.
The vapour pressure was determined by Tremain S P (1997) using a balance system where the
vapour pressure was determined at a number of temperatures using a mass difference
technique. The data were then extrapolated to provide a value for 25癈. There was a good
deal of scatter in the data, and no definitive value for the vapour pressure at 25癈 could be
calculated. However, it was estimated that the vapour pressure at this temperature was
around 1.12 x 10-6 kPa. It should be noted that the presence of 1-3% of triphenyl phosphate,
and a small quantity of residual phenol, both of which could be expected to be appreciably
more volatile than the resins, may have contributed to the scatter in the data, and to the
resulting estimated vapour pressure.
The water solubility was determined Hogg A S (1997) in triplicate using the flask method.
Approximately 10-13 mg of the test material was weighed into six separate flasks, then
shaken with 100mL of double-distilled water at 30癈 for 24, 48 and 72 hours using two
replicates for each period of agitation. Following this period of agitation the flasks were
allowed to stand for at least 24 hours at 20癈, and the resulting solutions were centrifuged,
filtered and analysed for the dissolved material using High Performance Liquid
Chromatography (HPLC). The water solubility at 20癈 was determined as 0.389 ?0.462
mg/L (mean 0.415 mg/L), and agitation time had no bearing on the individual results. The
pH of the solutions was slightly acid at between 5.5 and 6.
The Henry's Law Constant was calculated using the formula:
H = Vapour pressure x MW/Water solubility.
However, the estimated value of around 2 Pa/mol m3 (at 25癈) may not be appropriate since
the vapour pressure used may reflect large contributions from the volatile impurities tributyl
phosphate and phenol.
Hydrolytic degradation of the compound was studied as a function of pH (Hogg A S, 1997)
by incubating stoppered flasks containing (nominally) 0.25 mg/L in buffer solutions at pH 4,
7 and 9 for 5 days. The concentration of the compound in the solutions was determined using
HPLC at various times over the 5 day (120 hour) test period. Very little degradation was
observed in any of the buffers over the 5 day test period, with the maximum loss of 5% of
initial concentration observed in the pH 9 buffer. These data indicate that the phosphate ester
linkages within the molecules are stable to hydrolysis at 50癈. The small extent of observed
degradation extrapolated to 25 癈 indicates a half life of greater than 1 year at environmental
pH 4-9.
The n-octanol/water partition coefficient was determined by Iwami S (1995) by HPLC, where
the retention time of the test compound on C18 columns was compared with those for five
reference compounds of known Pow. The reference compounds included thiourea,
bromobenzene, diphenyl, dibenzyl and 2,4-DDT. The retention times of the components of
FULL PUBLIC REPORT 1 November, 2000
NA/773 5/28
the new material on the column were such that all components have log Pow > 6, indicating
high affinity for the oil phase. Large values of log Pow could be expected for the new material
as it contains a high proportion of aromatic or aliphatic hydrocarbon.
The value for log Koc, which is a measure of the compound's ability to bind to the organic
component of soils and sediments was also determined by Hogg A S (1997) by comparising
retention times on a C18 HPLC column. The method used was by Kordel W (undated) similar
to Method OECD TGP/94.75. Fifteen reference compounds were employed ranging from
simazine with log Koc = 1.77, to cyfluthrin with log Koc = 4.53. Since the retention time of
the new compound was greater than that of cyfluthrin, the value for log Koc exceeds 4.53.
This high value for log Koc indicates that the chemical will bind strongly to the organic
component of soils and sediments.
The new compound contains no acidic or basic groups, so dissociation constant data are not
relevant.
4. PURITY OF THE CHEMICAL
Degree of Purity: 75 - 95% (typical 88%)
Hazardous Impurities:
Chemical name: Phosphoric acid, triphenyl ester
Synonyms: Triphenyl phosphate
CAS No.: 115-86-6
Weight percentage: 2.2 - 2.4
Toxic properties: Cholinesterase inhibitor; Moderately toxic by ingestion;
Toxic by inhalation (HSDB)
NOHSC Exposure Standard 3 mg/m3 TWA (NOHSC,
1995)
Chemical name: Phenol
Synonyms: Carbolic acid
CAS No.: 108-95-2
Weight percentage: 0.07
Toxic properties: Toxic in contact with skin and if swallowed; Causes
burns; Irritating to eyes and skin (NOHSC, 1999b)
NOHSC Exposure Standard 1 ppm TWA (NOHSC,
1995)
Chemical name: Phenol, 4,4'-(1-methylethylidene)bis-
Synonyms: Bisphenol A
CAS No.: 80-05-7
Weight percentage: <0.01
Toxic properties: Irritating to eyes, respiratory system and skin; May
cause sensitisation by skin contact (NOHSC, 1995b)
FULL PUBLIC REPORT 1 November, 2000
NA/773 6/28
Non-hazardous Impurities
(> 1% by weight):
Chemical name: Oligomers of BPA-BDPP
Synonyms: None known
Weight percentage: 3.3 - 12.3 (see comments below)
CAS No.: Not assigned
Comment: The proportions of "dimer" (main component) and oligomers vary depending on
the grade required. The substance at the high end of the main component content range
would be a solid (hence elevated melting point) and in the low range, would be a liquid. For
handling purposes, the grade to be imported will be a liquid at ambient temperatures.
Additives/Adjuvants: None known
5. USE, VOLUME AND FORMULATION
The notified chemical, Fyrolflex BDP, will not be manufactured in Australia. It will be
imported as a component of various engineering thermoplastic resins, packed in 25 kg woven
polyethylene bags. The resins will be imported as non-inspirable granules (2 - 3 mm section
and 3 - 5 mm long) containing the notified chemical, ready for forming into end-use plastic
articles. There is also a possibility that the commercial form of the notified chemical will be
imported for subsequent formulation into a variety of engineering thermoplastic resins.
The notified chemical will be an ingredient for inclusion in the formulation of thermoplastic
resins, for the purpose of inhibiting burning or smouldering (flame retardant) of plastic
products made from these resins. The new chemical will be used as a fire/flame retardant at
up to 40% in engineering thermoplastics that will be fabricated for use in precision
engineering components.
The annual import volume of the notified resin is as follows:
Year Fyrolflex BDP in tonnes
1 40 ?50
2 40 ?50
3 40 ?50
4 50 ?60
5 50 ?60
6. OCCUPATIONAL EXPOSURE
Transport and Storage
Following importation, transport workers will deliver the resin granules to customers ready
for forming into plastic articles. These workers could be exposed to the notified chemical in
the case of an accident where the packaging is breached.
FULL PUBLIC REPORT 1 November, 2000
NA/773 7/28
Formulation
The notified chemical alone (88% typical concentration) will be imported in 200L drums and
reformulated at the notifier's site. Approximately 4 workers (2 storemen, 1 batch weigher
and 1 equipment operator) will have the potential for exposure to the notified chemical on a
regular basis. During formulation, the drums containing the notified chemical are manually
opened and a suction pump inserted to deliver the notified chemical from the drums. The
required amount of the notified chemical is pumped via a metering device and control valve
through an injection nozzle into the polymer blend in the extruder. The molten mixture is
extruded via a die (2-3 mm column), allowed to cool, then chopped into granules. The plastic
granules are conveyed into the bagging station, packed and sold to plastic manufacturers.
During the hot-melt extrusion process, the notified chemical becomes encapsulated within the
plastic granules. Production of the resin granules is undertaken in purpose built facilities,
fitted with vacuum extraction equipment to trap fugitive dust emissions and with bunding to
contain liquid spills and leaks.
Workers opening drums and manipulating (connecting and disconnecting) the suction pumps
during transfer operations may experience dermal exposure to the notified chemical.
Potential for skin and eye contact to spills and leaks may also occur during cleaning up
operations and maintenance of equipment. All workers involved in the production of resin
granules, clean up and maintenance will wear personal protective equipment including PVC
gloves, safety glasses and overalls. Local exhaust ventilation is employed when the notified
chemical is drawn from the 200L drums and pumped into the extrusion equipment. Similarly,
the extruder loading and exit areas are fitted with local ventilation to capture fugitive
emissions from the heated resin. Once the resin granule is extruded, the notified chemical at
10-20% is within the polymer matrix and would not be available for exposure.
End use
Up to 25 plastic manufacturing establishments are expected to use the resin granules. Each
manufacturing site anticipates that 2 workers will handle the resin granules during plastic
manufacture. Approximately 2 to 3 tonnes of resin granules will be weighed into the heat-
forming equipment in each 24 hours. The resin granules will be fed into the hopper of an
injection moulding machine. Once heated, the melted granules are moulded to form the shape
of the plastic article, then cooled.
Skin contact when opening bags and charging the resin product into the heat-moulding
machine may occur. However, worker exposure is not anticipated since the notified chemical
is encapsulated within the polymer matrix and would not be available for exposure. The
notifier indicated that the resin granule is resistant to abrasion, hence generation of dust will
be minimised. Workers handling the granules containing the notified chemical will wear
protective equipment including gloves, safety glasses, overalls, and face shield when
necessary. The process areas are fitted with local exhaust ventilation to capture fugitive
vapours from the heated resin. Handling of finished articles made from resin granules would
not pose any health risk to workers.
7. PUBLIC EXPOSURE
Public contact to the notified substance is likely to be widespread, as the notified chemical is
incorporated in moulded articles for use in electronic and electrical components which will be
FULL PUBLIC REPORT 1 November, 2000
NA/773 8/28
sold to the public. However, the notified chemical will be encapsulated within the plastic
articles and is not expected to leach, resulting to a negligible exposure to the public.
8. ENVIRONMENTAL EXPOSURE
Release
Very little release of the chemical is anticipated during use of the formulated granules in the
preparation of the moulded, or extruded plastic products. Weighed amounts of the solid
granules containing the flame retardant are blended, melted and extruded into forms
convenient for downstream manufacturing or further processing. Fugitive release of fine
powder during the blending/extrusion operations is not expected to be large with the majority
collected by vacuum extraction equipment. These measures would prevent release to the
wider environment, and the dust collected in the vacuum filter/extraction equipment is
periodically removed and probably disposed of into landfill.
The notifier did not indicate the fate of empty polypropylene bags, but it is expected that these
would be either incinerated or placed into landfill. Due to the high cost of the new chemical,
it is unlikely that large quantities would be disposed of with the empty bags. It is considered
that a maximum of 1% of import quantities (ie around 500 kg per annum) would be disposed
of via this route.
A liquid form of the chemical may be used for formulating resin granules in Australia. The
notifier indicated that residuals left in the 200L drums would be drained, however, it is
anticipated that some chemical (estimated at 0.5%) would remain in the drums. If it is
assumed that 50% of the imported volume is used in manufacture of the resin granules (ie 30
tonnes per annum), release could be 150 kg each year. The notifier did not indicate the fate of
empty drums, but it is likely that these would be sent to a drum recycling facility where
residual compound would be washed out with steam and/or solvents. The released compound
would ultimately become incorporated into waste sludge, to be either incinerated or be placed
into landfill. There is potential for some release of resin containing the new chemical from
pipes and ducts in the extrusion equipment during routine maintenance of equipment.
However, most of this is expected to be salvaged and added to later production batches, or if
not re-used is expected to be placed into landfill.
Initially resin formulations containing the new chemical are to be used in the manufacture of
moulded casings for electrical equipment, and internal fittings for motor vehicles.
Consequently, articles containing the notified chemical are likely to have a wide distribution
throughout the community which indicates that long term release of the chemical following
the discarding of old consumer products or electrical equipment, would be very diffuse.
Some release of the chemical is likely as a result of "blooming" from the manufactured
articles during day to day use. This process is effectively the slow diffusion of the chemical
from the interior of the plastic article to the surface, and here it may be removed through
cleaning processes and released in waste water (presumably mainly to sewer). However,
release through this route is expected to be diffuse and at very low levels. The notifier
indicated that the rate of blooming of the new compound from the plastic articles is low.
FULL PUBLIC REPORT 1 November, 2000
NA/773 9/28
While recycling of the plastic in discarded articles is theoretically possible, it is not
anticipated to take place on a large scale. Consequently, the majority of the imported
chemical will be discarded with old plastic articles at the end of their useful lives, and these
are likely to be either incinerated or be placed into landfill.
Fate
A test for ready biodegradability conducted according to the Modified MITI (OECD Test
Guideline 301C) indicated that the chemical only very slowly degraded under the conditions
of the test (Iwami S, 1994). Biological oxygen demand (BOD) measurements after 28 days
incubation of the test substance with sewage sludge indicated a maximum of 6% degradation,
while analytical determinations of the residual compound in the BOD bottles indicated a
maximum of 3% degradation. The reference compound aniline, was 72% degraded over a
28-day test period. The result of this test indicates that the new chemical is not readily
biodegradable.
Although little of the new chemical is likely to be released during manufacturing processes,
any release is likely to be placed into landfill. The notifier indicates that this is the preferred
method for disposal. The eventual fate of the majority of the imported chemical will be
strongly linked to that of discarded plastic articles, and this is likely to be either placed into
landfill or be incinerated.
The chemical to be disposed of to landfill will be incorporated and immobilised in a solid
resin matrix (ie the plastic article). However, the resin matrix will be slowly degraded
through the biological and abiotic processes operative in landfills, to release the notified
chemical. Diffusion of the resin to the surface of broken pieces of plastic (ie "blooming" as
discussed above) would contribute to this mode of release.
The compound has a large Koc (log Koc > 4.53), indicating strong affinity for the organic
component of soils and sediments, and low mobility in these media. The chemical is not
readily biodegradable, but when bound to, or otherwise associated with soils and sediments, it
could be expected to be slowly degraded through the agency of biological and abiotic
processes operative within landfills.
Complete combustion of the chemical in the presence of excess oxygen would be expected to
destroy the material with production of water vapour and oxides of carbon. Some solid
phosphate salts would also be formed, and incorporated into the waste incinerator ash.
The high log Pow (> 6), relatively low molecular weight (693 g/mol) and low water solubility
(0.4 mg/L) indicate large potential for bioaccumulation (Connell, 1990). However, since it is
expected that the compound will slowly biodegrade, and is in any case unlikely to enter the
water compartment in significant volumes the risks associated with bioaccumulation are
expected to be small.
9. EVALUATION OF TOXICOLOGICAL DATA
Tests were performed according to EEC/OECD guidelines (European Economic Community,
1992; Organisation for Economic Co-operation and Development, 1995-1996), at facilities
complying with OECD Principles of Good Laboratory Practice.
FULL PUBLIC REPORT 1 November, 2000
NA/773 10/28
All toxicity studies were conducted on the notified chemical, BPA-BDPP.
9.1 Acute Toxicity
Summary of the acute toxicity of BPA-BDPP
Test Species Outcome Reference
acute oral toxicity Rat LD50>2000 mg/kg ((Allen D J,
1997d)
acute dermal toxicity Rat LD50>2000 mg/kg (Allen D J,
1997b)
skin irritation Rabbit Non-irritant (Allen D J,
1997a)
eye irritation Rabbit Non-irritant ((Allen D J,
1997c)
skin sensitisation Guinea pig Non-sensitising (Driscoll R, 1997)
9.1.1 Oral Toxicity (Allen D J, 1997d)
Species/strain: Rat/Sprague Dawley CD
Number/sex of animals: 5/sex
Observation period: 14 days
Method of administration: 2 000 mg/kg test substance in arachis oil suspension
administered by oral (gavage)
Test method: OECD TG 401; limit test
Mortality: No deaths were recorded.
Clinical observations: No clinical signs of toxicity were noted.
Morphological findings: No abnormalities were noted at necropsy.
Comment: All animals showed expected gain in bodyweight.
LD50: >2 000 mg/kg
Result: The notified chemical was of very low acute oral toxicity in
rats.
FULL PUBLIC REPORT 1 November, 2000
NA/773 11/28
9.1.2 Dermal Toxicity (Allen D J, 1997b)
Species/strain: Rat/Sprague Dawley CD
Number/sex of animals: 5/sex
Observation period: 14 days
Method of administration: The test substance was moistened in water before
application. A dose of 2 000 mg/kg was applied under semi-
occlusive dressing to an area of shorn skin on the back and
flank for 24 hours.
Test method: OECD TG 402, limit test
Mortality: No deaths were recorded.
Clinical observations: No clinical signs of toxicity were noted.
Morphological findings: No signs of skin irritation were noted during the study. No
abnormalities were noted at necropsy.
Comment: All animals showed expected gain in bodyweight.
LD50: > 2 000 mg/kg
Result: The notified chemical was of low dermal toxicity in rats.
9.1.3 Inhalation Toxicity
An inhalation toxicity study was not provided.
9.1.4 Skin Irritation (Allen D J, 1997a)
Species/strain: Rabbit/New Zealand White
Number/sex of animals: 3 males
Observation period: 3 days
The test substance was heated to 55 癈 to form a liquid
Method of administration:
before use. A volume of 0.5 mL was applied for 4 hours to a
prepared site on the dorsal aspect of the animals by a patch
held in place by tape. Observations were recorded 1, 24, 48
and 72 hours after patch removal.
Test method: OECD TG 404
FULL PUBLIC REPORT 1 November, 2000
NA/773 12/28
Comment: No signs of irritation were noted during the study. The test
substance produced a primary irritation index of 0.0 for
erythema and oedema.
Result: The notified chemical was non-irritating to the skin of
rabbits.
9.1.5 Eye Irritation (Allen D J, 1997c)
Species/strain: Rabbit/New Zealand White
Number/sex of animals: 3 males
Observation period: 3 days
Method of administration: A volume of 0.1 mL was instilled into the conjunctival sac
of the right eye and the lids were held together for
approximately one second before release. The left eye
served as control.
Test method: OECD TG 405
Comment: Residual test material was noted around the treated eye of
one animal one hour after treatment. No corneal or iridial
effects were noted during the study. Minimal conjunctival
redness was noted in one treated eye one hour after
treatment. All treated eyes appeared normal at the 24-hour
observation. Mean scores for all ocular lesions at 24, 48 and
72 hours were 0 for all animals.
Result: The notified chemical was non-irritating to the eyes of
rabbits.
9.1.6 Skin Sensitisation (Driscoll R, 1997)
Species/strain: Guinea pig/Dunkin Hartley
Number of animals: 10 test, 5 controls
Induction procedure: Test animals
Day 1 ?intradermal induction
Hair was removed from the shoulder region of animals and a
row of three injections was made on each side of the mid
line.
Injections were
1:1 (v/v) Freunds Complete Adjuvant (FCA):water
FULL PUBLIC REPORT 1 November, 2000
NA/773 13/28
5% (w/v) test substance in arachis oil
5% (w/v) test substance in a 1:1 preparation of FCA plus
distilled water
Day 8 ?topical induction
A patch containing test substance (75% w/w in arachis oil)
was applied to the same site and secured with tape for 48
hours.
Control animals
Control animals were treated in a similar manner to test
animals excluding the test substance.
Challenge procedure: Day 22
Doses of 50 and 75% w/w of test substance in arachis oil
were applied to the prepared flank of animals and secured
under occlusive conditions. After 24 hours, the dressings
were removed and the test areas cleansed. Evaluations of
reactions of erythema and oedema were made after another
24 and 48 hours.
Test method: OECD TG 406; Maximisation test of Magnusson and
Kligman
Comment: One test group animal was killed due to weight loss and
breathing difficulties on day 16. These effects were not
considered to be treatment-related.
No skin reactions were noted at the challenge sites of test
and control animals at the 24 and 48-hour observations.
No adverse effects on bodyweight gain were noted.
Result: The notified chemical was non-sensitising to the skin of
guinea pigs
9.2 Repeated Dose Toxicity (Thomas O N, 1997)
Species/strain: Rat/Sprague Dawley Crl:CD
Number/sex of animals: 5/sex/group; 3 test groups, 1 control group, 2 recovery
groups (high dose and vehicle)
Method of administration: Oral (gavage)
Dose/Study duration: 0, 15, 150, 1000 mg/kg/day for 28 consecutive days
followed by a 14 day treatment free (recovery) period
FULL PUBLIC REPORT 1 November, 2000
NA/773 14/28
Test method: EEC Directive 92/69/EEC, Method B7
Clinical observations
There were no deaths during the study period.
One control male developed a scab in the dorso-cervical region from day 7 to day 16, which
was attributed to injury. A female in the 150 mg/kg/day group had clinical signs including
hunched posture and pilo-erection but these were not considered to be treatment-related
since these effects were not detected at 1 000 mg/kg/day.
Clinical Chemistry/Haematology
Blood chemistry
A statistically significant reduction or increase in alanine amino transferase (ALT) was
detected in males at 15 or 150 mg/kg/day, respectively, compared with controls. In the
absence of adverse effects at the high dose level of 1000 mg/kg/day, and that the values
were within the normal range for this strain of rat, these findings were not considered to be
treatment-related.
Males treated with 15 or 1000 mg/kg/day also showed a statistically significant reduction in
aspartate amino transferase (AST). As these levels were also in the normal range, they
were not considered to be toxicologically important.
Urinalysis
Recovery 1000 mg/kg/day females showed a statistically significant reduction in urine
volumes and increase in urine specific gravity compared with controls. Since no such
changes were detected following 28 days of treatment, they were not considered to be
toxicologically important.
FULL PUBLIC REPORT 1 November, 2000
NA/773 15/28
Pathology
Organ weights
The statistically significant increases in absolute ovary weight detected for females treated
with 1000 or 150 mg/kg/day and the reduction in absolute liver weight detected in recovery
1000 mg/kg/day females were not reflected in the relative weights. These effects were
therefore not considered to be treatment-related.
Necropsy
The incidental findings recorded for one recovery control male and one non-recovery
control female, identified as hydronephrosis of the right kidney or dark patches on all lobes
of the lung, respectively, showed no dose-response relationship and were consistent with
normally expected low findings for this strain of rat. These effects were therefore not
considered to be treatment-related.
Histopathology
The reported microscopic cardiac, hepatic and renal findings were consistent with normally
expected low findings for this strain of rat. There were also microscopic changes in the
lung of one non-recovery female, associated with macroscopic findings and more probably
representing an artefactual, procedure-related lesion. These effects were therefore not
considered to be treatment-related.
Comment: Oral administration of the notified chemical to rats for a
period of 28 consecutive days at dose levels up to 1000
mg/kg/day produced no treatment-related changes in the
parameters measured.
Result: The notified chemical was considered to have a "No
Observed Adverse Effect Level" (NOAEL) of 1000
mg/kg/day.
9.3 Genotoxicity
9.3.1 Salmonella typhimurium and Eschericia coli Reverse Mutation Assay (Thompson
P W, 1997)
Strains: Salmonella typhimurium TA1535, TA1537, TA98 and
TA100, and Escherichia coli CM891 (WP2uvrA)
0, 50, 150, 500, 1500, 5000 礸/plate dissolved and diluted in
Concentration range:
acetone
Metabolic activation: 10% rat liver S9 fraction (Aroclor 1254-induced) in standard
cofactors
TA98 + S9: 0.5 礸/plate 2-aminoanthracene
Positive controls:
TA98 ?S9: 0.2 礸/plate 4-nitroquinoline-1-oxide
TA100 + S9: 1 礸/plate 2-aminoanthracene
FULL PUBLIC REPORT 1 November, 2000
NA/773 16/28
TA100 ?S9: 3 礸/plate N-ethyl-N-nitro-N-nitrosamine
(ENNG)
TA1535 +S9: 2 礸/plate 2-aminoanthracene
TA1535 ?S9: 5 礸/plate ENNG
TA1537 + S9 2 礸/plate 2-aminoanthracene
TA1537 ?S9: 80 礸/plate 9-aminoacridine
CM891 + S9: 10 礸/plate 2-aminoanthracene
CM891 ?S9: 2 礸/plate ENNG
Test method: OECD TG 471 & 472
Comment: Each experiment, in the presence and absence of S9, was
repeated once and all concentrations were tested in triplicate.
Precipitation was observed at and above 500 礸/plate but did
not interfere with scoring of revertant colonies.
Under the conditions of the study, the notified chemical
caused no substantial increases in revertant colony numbers
over control counts at any concentration in either the
presence or absence of the rat liver microsomal enzymes.
All positive and negative controls responded appropriately.
Result: The notified chemical was considered to be non-mutagenic
under the conditions of the assay.
9.3.2 Chromosome aberration test in CHL cells in vitro (Durward R, 1997)
Cells: Chinese hamster lung (CHL) cells
Metabolic activation: 50% rat liver S9 fraction (Aroclor 1254-induced) in standard
cofactors
Experimental design: Two independent experiments were conducted in duplicate.
The experimental design and concentrations tested are
tabulated below:
FULL PUBLIC REPORT 1 November, 2000
NA/773 17/28
Metabolic Experiment No Test substance Controls
?br>
Activation concentration (礸/mL)
Positive:
-S9 1 12 hour continuous exposure:
Mytomycin C (MMC) ?br>
0*, 156.25, 312.5, 625*, 1 250*,
0.075 礸/mL
2 500*, 5 000
Negative:
Dimethyl sulphoxide (DMSO) ?br>
500mg/mL
Positive:
2 12 hour continuous exposure (12 hour
MMC ?0.075 礸/mL (12 hours
harvest):
0*, 156.25*, 312.5*, 625*, 1 250*, harvest);
2 500*, 3 750* Cyclophosphamide (CP) 10 礸/mL
(24 hour harvest);
6 hours exposure, 18 hour harvest MMC ?0.05 礸/mL (24 hour
(24 hour harvest): continuous exposure)
0*, 156.25*, 312.5*, 625*, 1 250*, MMC ?0.025 (48 hour continuous
2 500*, 5 000 exposure)
24 and 48 hours continuous exposure: Negative:
0*, 156.25, 312.5, 625*, 1 250*, DMSO ?375 mg/mL (12 hour
2 500*, 5 000 continuous exposure);
DMSO ?500 mg/mL (6, 24 and 24
hour exposure)
Positive:
+S9 1 4 hours exposure, 8 hour harvest :
CP - 10 礸/mL
0*, 156.25*, 312.5*, 625*, 1 250*,
2 500*, 5 000
Negative:
DMSO ?500 mg/mL
Positive:
2 4 hours exposure, 8 hour harvest
CP ?10 礸/mL
(12 hour harvest):
0*, 156.25*, 312.5*, 625*, 1 250*,
2 500*, 3 750* Negative:
DMSO ?375 mg/mL (12 hour
6 hours exposure, 18 hour harvest (24- continuous exposure);
hour harvest): DMSO ?500 mg/mL (6 hour
0*, 156.25*, 312.5*, 625*, 1 250*, exposure)
2 500*, 5 000
- cultures selected for metaphase analysis
FULL PUBLIC REPORT 1 November, 2000
NA/773 18/28
Test method: EC Directives 87/18/EEC and 88/320/EEC
Comment: A poor response was seen in the 12-hour treatment
experiment with and without metabolic activation which was
considered to be due to toxicity-related cell cycle delay
typical of early cell harvest time-points. The test substance
was marginally toxic to CHL cells in all six treatment cases,
indicating the appropriateness of the selection of dose
concentrations.
The test substance did not induce any significant or dose-
related increases in the frequency of cells with aberrations in
either experiment.
All positive and negative controls responded appropriately.
Result: The notified chemical was considered to be non-clastogenic
under the conditions of the study.
9.4 Overall Assessment of Toxicological Data
The notified chemical was of very low acute oral toxicity (LD50 >2 000 mg/kg) and low acute
dermal toxicity (LD50 >2 000 mg/kg) in the rat. An inhalation study was not provided. It was
non-irritating to rabbit skin and eye and non-sensitising to guinea pig skin.
In a 28-day repeat dose oral toxicity study in rats there were statistically significant findings
related to clinical chemistry, organ weight parameters, and macroscopic and microscopic
changes in the kidney and lung. However, the findings were not dose-related and were
considered not to be treatment-related. The results of the study allowed an NOAEL of 1000
mg/kg/day (highest dose tested) to be clearly established.
In genotoxicity studies, the notified chemical was not mutagenic in bacteria, nor did it induce
an increased incidence of chromosomal aberrations in Chinese hamster lung cells in vitro. In
vivo tests were not provided.
Hazard Classification
Based on the above studies, the notified chemical has a toxicology profile which does not
require classification as a hazardous substance according to NOHSC Approved Criteria for
Classifying Hazardous Substances (National Occupational Health and Safety Commission,
1999a).
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
The notifier provided the following ecotoxicity data, which were performed in accordance
with OECD Test Guidelines.
FULL PUBLIC REPORT 1 November, 2000
NA/773 19/28
Test Species Results (Nominal)
LC50(96 h) >1mg/L
Acute Toxicity Oncorhynchus mykiss
[OECD 203] (Rainbow trout) NOEC >1mg/L
Acute Immobilisation Daphnia magna EC50(48 h) >1mg/L
[OECD 202 ] NOEC >1mg/L
Inhibition of Algal Growth Selanastrum subspicatus EbC50 (72 h) >1mg/L
NOEC >1mg/L
[OECD 201]
Inhibition of Bacterial Respiration Activated sludge bacteria Not inhibitory ?see notes below.
[OECD 209]
Fish (Wetton P M, 1997b)
The acute test on rainbow trout was a Static Limit Test (no replacement of test water)
performed over 96 hours using a solution of the test substance made up at a nominal
concentration of 1 mg/L in charcoal filtered dechlorinated tap water. The test was performed
in duplicate using ten fish in each test vessel. A solvent control was also run in parallel, also
using ten fish. During the tests the temperature was controlled at 14 ?1oC, while the pH was
always between 7.7 and 8.0, dissolved oxygen between 9.4 and 10.1 mg/L and water hardness
around 100 mg/L as CaCO3.
It is to be noted that the nominal concentration of 1.0 mg/L for the test chemical was greater
than the measured water solubility (0.4 mg/L), and in order to attain this nominal
concentration, the test substance was firstly dissolved in dimethylformamide to produce a
10 g/L solution. An aliquot of this was added to the test vessels in order to produce the
indicated nominal concentrations. However, analysis of samples of the test solutions taken at
0, 24 and 96 hours indicated up to 115% recovery of the test compound. Presumably the
presence of the dimethylformamide in the water helped maintain this high solution
concentration. It was noted in the report that during work on the initial range finding study
test material precipitated out of solution at concentrations in excess of 1.0 mg/ L.
All test specimens survived over the 96 hour test period. Further, no physical or behavioural
anomalies were observed during the test period, and accordingly it was concluded that the
new chemical is non toxic to rainbow trout up to the limits of its water solubility.
Daphnia (Wetton P M, 1997a)
The tests on Daphnia magna were conducted over a 48 hour period, using a static limit test
methodology. As with the fish test above the test solution was prepared using
dimethylformamide. Four replicate tests were conducted using ten Daphnia in each test
vessel, together with a solvent control, using ten test animals. During the tests the
temperature was controlled at 21?1癈, while the pH was always between 7.9 and 8.1,
dissolved oxygen between 7.7 and 8.2 mg/L and water hardness around 100 mg/L as CaCO3.
Analysis of duplicate samples of the water for the new compound after the 48 hour test period
found concentrations of 1.03 and 1.06 mg/L, which was around 105% of the nominal
concentration.
No immobilisation of any of the 40 test Daphnia was observed during the course of the test,
nor was any other aberrant behaviour observed. These results indicate that the new chemical
is not toxic to this species up to the limits of its water solubility.
FULL PUBLIC REPORT 1 November, 2000
NA/773 20/28
Algae (Mead C, 1997a)
A limit test on the inhibition of algal growth was also conducted on Selanastrum subspicatus
over a 72 hour incubation period at 21 ?1oC with nominal concentration of the test material
of 1.0 mg/L. The test material was introduced to the solutions in the manner indicated in the
studies above. Six replicate tests were conducted in 250 mL Erlenmeyer flasks, together with
three control flasks containing no chemical. Three solvent controls (ie water and the
appropriate amount of dimethylformamide) were also run. Each flask contained 100 mL of
the test medium, and the flasks were continuously agitated to maintain the algal cells in
suspension. The pH of the test solutions increased from around 8.0 at the start of the period,
to around 10 after 72 hours. The growth of algal biomass was determined over the test period
by measurement of cell density using absorbance at 665 nm. At 0 hours the mean cell
density in the control was 1.85 x 104 cell/mL, increasing to 2.17 x 106 cells/mL after 72
hours. The corresponding values for the solvent control were 2.17 x 104 and 1.3 x 106
cell/mL, respectively. While the report did not detail the actual cell densities for the test
media, the absorbance closely paralleled that of the controls (and solvent control), and
consequently it was concluded that the new compound is not inhibitory to growth of algae up
to the limits of its water solubility.
Analysis of the solutions for the test compound after 72 hours indicated approximately 74%
recovery (compared with a nominal initial concentration of 1 mg/L). This suggests that some
of the test material had adsorbed to the surface of the algal cells.
Sewage Bacteria (Mead C, 1997b)
A test on the inhibition of bacterial respiration was also conducted. The test substance was
suspended in artificial sewage at nominal loadings of 20, 500 and 1,000 mg/L using a 30
minute sonication to assist dispersion. The test flasks were inoculated with sewage sludge
bacteria and aerated for 30 minutes. Following aeration the contents of the flasks were
poured into darkened 300 mL BOD bottles fitted with oxygen sensing electrodes. The rate of
oxygen consumption was measured for the dispersions, and compared with the vessel. None
of the tests indicated any significant inhibition of bacterial respiration compared with the
controls, and it was concluded that the new chemical is not toxic to sewage bacteria up to the
limits of its water solubility.
In contrast to the new chemical, the reference substance with 3,5-dichlorophenol inhibited
bacterial respiration by 7% at a test concentration of 3.2 mg/L, and 84% at 32 mg/L.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The environmental hazard from the notified chemical is not expected to be high when it is
used for the manufacture of plastic cases for electronic equipment and fixtures for vehicle
interiors as indicated in the notification statement.
Very little of the chemical is expected to be released during manufacturing processes, and
while no figures were provided, it is estimated that release would amount to around 0.5% of
import quantities, or a maximum of 150 kg per year. However, some slow release of the
chemical may occur as a result everyday use and cleaning of the resin articles, and this is
likely to enter the sewer system with discarded cleaning water. In the sewer the compound
will become strongly associated with sediments.
FULL PUBLIC REPORT 1 November, 2000
NA/773 21/28
Plastic articles containing the new compound such as computer cases, cabinets or cases for
other electronic or electrical equipment or vehicle fixtures are unlikely to be recycled, and
consequently at the end of their useful lives will be discarded. The discarded articles are most
is likely to be placed into landfill or be incinerated.
If placed into landfill, the compound is likely to be slowly released as a consequence of the
slow degradation of the resin matrix in which it is encapsulated. Once released in this
manner it is expected to become associated with the organic component of soils and
sediments. The chemical is not readily biodegradable, and the available data indicates that it
is only very slowly degraded by sewage bacteria. However, once released and adsorbed to
soils and sediments in a landfill it is expected to be slowly degraded through the biological
and abiotic processes operative in these situations.
Very little of the compound is expected to enter the water compartment so exposure to
aquatic organisms is expected to be low. The chemical is not toxic to those aquatic species
against which it has been tested up to the limits of its water solubility, so any release to the
water compartment would entail a low environmental hazard. The new chemical is not readily
biodegradable and the high log Pow, the modest molecular weight and low water solubility
indicate high potential for bioaccumulation. However, any potential for bioaccumulation will
be mitigated by the expected low exposure to the water compartment.
The notifier provided a summary of a risk assessment performed according to the European
evaluation scheme. The risk assessment evaluated the predicted environmental concentration
(PEC) of the chemical based on 50% release to the environment. This was compared with the
predicted no effect concentration (PNEC) based on a safety factor of 1 000. The hazard
quotient (PEC/PNEC) was 5.7 for release to a local environment, and less than 1 for regional
use and waste. These results were interpreted to indicate the chemical was of no immediate
concern.
It is of interest to note that unlike many currently used fire/flame retardant compounds, the
new chemical does not contain halogens such as chlorine and bromine. Use of the new
material offers environmental advantages over halogenated compounds, since its incineration
will not entail risk of production of halogenated dioxins and furans. This aspect of
halogenated flame retardants has raised some wide environmental concerns due to the
environmental persistence of the compounds themselves, and their potential for dioxin
production in fires.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
The notified chemical will be imported as a component of a granulated resin product, at up to
40%. The resin product is presented as plastic granules (2 ? mm section and 3 - 5 mm
long) highly resistant to abrasion. The resin granules will be processed to form plastic
articles. When heat-melted into finished articles, the notified chemical is bound within a
plastic matrix. The commercial form of the notified chemical (88% typical concentration) is
likely to be imported in future.
FULL PUBLIC REPORT 1 November, 2000
NA/773 22/28
The notified chemical was of very low acute oral toxicity (LD50 >2 000 mg/kg) and low acute
dermal toxicity (LD50 >2 000 mg/kg) in rats. It was non-irritating to rabbit skin and eye and
non-sensitising to guinea pig skin. In a 28-day repeat dose oral toxicity study in rats allowed
an NOAEL of 1 000 mg/kg/day (highest dose tested) to be clearly established. The notified
chemical was not mutagenic in bacteria, nor did it induce an increased incidence of
chromosomal aberrations in Chinese hamster lung cells in vitro. In vivo tests were not
provided.
Based on the above studies, the notified chemical is not considered to be a hazardous
substance according to NOHSC Approved Criteria for Classifying Hazardous Substances
(National Occupational Health and Safety Commission, 1999a) and will not require labelling
with specific risk phrases.
Occupational Health and Safety
Transport and Storage
Exposure to the notified chemical is not expected during transport or storage as long as the
packaging remains intact. The risk of adverse health effects for transport and storage workers
is considered to be low.
Formulation of Resin Granules
In the event that the liquid notified chemical is imported for processing into formulated resin
granules, dermal exposure by workers opening drums, connecting and disconnecting suction
pumps during transfer operations may occur. The blending and extrusion processes are
described as enclosed and automated, therefore further exposure would be limited. Workers
involved in bagging of resin granules would have low exposure since after heat-melt
processing, the notified chemical is encapsulated within the resin granules. The production
facilities are fitted with vacuum extraction equipment to trap fugitive dust and vapour
emissions and with bunding to contain liquid spills and leaks. All workers involved in the
production of resin granules will wear protective equipment including gloves, safety glasses
and overalls. Based on the extensive use of engineering controls such as enclosure and local
exhaust ventilation, and the low toxicity of the notified chemical, the health risk to workers is
low during the formulation process.
End-Use
The preparation of the moulded and extruded finished articles from resin granules is
performed in purpose built facilities fitted with vacuum extraction equipment, to minimise
release of fugitive particulate material. There is potential for skin contact when opening bags
and charging the resin product into the injection-moulding equipment. However, worker
exposure is considered negligible since the notified chemical is encapsulated within the resin
granules. The potential for inhalation and eye exposure is low because the notified chemical
is presented as plastic granules resistant to abrasion. Workers handling the notified chemical
will wear protective equipment including gloves, safety glasses, overalls and face shield when
necessary. Occupational exposure to the notified chemical cannot occur before or after the
articles are made since the notified chemical is encapsulated within the finished plastic
articles. In this form, the notified chemical is not bioavailable, hence health risk to workers is
expected to be negligible.
FULL PUBLIC REPORT 1 November, 2000
NA/773 23/28
Public Health
Public exposure to the notified chemical is likely to be widespread, as consumer and
automotive plastics containing the notified chemical will be sold to the public. Once the
formulated resin blend containing the notified chemical is formed into plastic products, it is
encapsulated within the resin matrix of the plastic, rendering the notified chemical
biologically unavailable. Consequently, the potential for public exposure to the notified
chemical throughout all phases of its life cycle is considered to be low. Based on this
information, it is considered that the notified chemical will not pose a significant hazard to
public health when used in the proposed manner.
13. RECOMMENDATIONS
To minimise occupational exposure to Fyrolflex BDP the following guidelines and
precautions should be observed:
? Safety goggles should be selected and fitted in accordance with Australian Standard
(AS) 1336 (Standards Australia, 1994) to comply with Australian/New Zealand
Standard (AS/NZS) 1337 (Standards Australia/Standards New Zealand, 1992);
industrial clothing should conform to the specifications detailed in AS 2919
(Standards Australia, 1987) and AS 3765.1 (Standards Australia, 1990); impermeable
gloves should conform to AS/NZS 2161.2 (Standards Australia/Standards New
Zealand, 1998); all occupational footwear should conform to AS/NZS 2210
(Standards Australia/Standards New Zealand, 1994);
? Spillage of the notified chemical should be avoided. Spillages should be cleaned up
promptly with absorbents which should be put into containers for disposal;
? Good personal hygiene should be practised to minimise the potential for ingestion;
? A copy of the MSDS should be easily accessible to employees.
14. MATERIAL SAFETY DATA SHEET
The MSDS for the notified chemical was provided in a format consistent with the National
Code of Practice for the Preparation of Material Safety Data Sheets (National Occupational
Health and Safety Commission, 1994).
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information remains the
responsibility of the applicant.
FULL PUBLIC REPORT 1 November, 2000
NA/773 24/28
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, secondary notification may be required if any of the circumstances stipulated
in subsection 64(2) of the Act arise. No other specific conditions are prescribed.
16. REFERENCES
Allen D J (1997a) BPA-BDPP: Acute Dermal Irritation Test In The Rabbit, Project No.
Safepharm Laboratories Limited, Derby.
Allen D J (1997b) BPA-BDPP: Acute Dermal Toxicity (Limit Test) In the Rat, Project No.
106/014, Safepharm Laboratories Limited, Derby.
Allen D J (1997c) BPA-BDPP: Acute Eye Irritation Test In The Rabbit, Project No. 106/016,
Safepharm Laboratories Limited, Derby.
Allen D J (1997d) BPA-BDPP: Acute Oral Toxicity (Limit Test) In the Rat, Project No.
106/013, Safepharm Laboratories Limited, Derby.
Connell DW (1990) General Characteristics of Organic Compounds Which Exhibit
Bioaccumulation. In: D. W. Connell ed. Bioaccumulation of Xenobiotic Compounds. CRC
Press, Boca Raton.
Driscoll R (1997) Bisphenol A Bis (Diphenylphosphate): Magnusson & Kligman
Maximisation Study In The Guinea Pig, Project No. 106/042, Safepharm Laboratories
Limited, Derby.
Durward R (1997) BPA-BDPP: Chromosome Aberration Test in CHL Cells In Vitro,
Project No. 106/020, Safepharm Laboratories Limited, Derby.
European Economic Community (1992) EEC Directive 92/69/EEC on the Approximation of
the Laws, Regulations and Administrative Provisions Relating to the Classification,
Packaging and Labelling of Dangerous Preparations.
Hogg A S (1997) Determination of General Physico-Chemical Properties, Project No.
106/010, Safepharm Laboratories Limited, Derby.
Iwami S (1994) Ready Biodegradability Test of E-890, Project No. 4F020G, Mitsubisi-kasei
Institute of Environmental Science, Japan.
Iwami S (1995) Determination of 1-octanol/water Partition Coefficient of E-890 by HPLC
Method, Project No. Mitsubishi Chemical Safety Institute Ltd, Japan.
Kordel W (undated) HPLC-Screening Method for the Determination of the Adsorption-
Coefficient on Soil-Comparison of Different Stationary Phase, Project No. Fraunhoger-
Institut fur Umweltchemie und Okotoxikologie, Germany.
FULL PUBLIC REPORT 1 November, 2000
NA/773 25/28
Mead C (1997a) BPA-BDPP: Algal Inhibition Test, Project No. 106/023, Safepharm
Laboratories Limited, Derby.
Mead C (1997b) BPA-BDPP: Assessment of the Inhibitory Effect on the Respiration of
Activated Sewage Sludge, Project No. 106/024, Safepharm Laboratories Limited, Derby.
National Occupational Health and Safety Commission (1994) National Code of Practice for
the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Canberra, Australian
Government Publishing Service.
National Occupational Health and Safety Commission 1995, `Adopted National Exposure
Standards for Atmospheric Contaminants in the Occupational Environment',
[NOHSC:1003(1995)], in Exposure Standards for Atmospheric Contaminants in the
Occupational Environment: Guidance Note and National Exposure Standards, Australian
Government Publishing Service, Canberra.
National Occupational Health and Safety Commission (1999a) Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1999)]. Canberra, Australian Government
Publishing Service.
National Occupational Health and Safety Commission (1999b) List of Designated Hazardous
Substances [NOHSC:10005(1999)]. Australian Government Publishing Service, Canberra.
Organisation for Economic Co-operation and Development (1995-1996) OECD Guidelines
for the Testing of Chemicals on CD-Rom. Paris, OECD.
Standards Australia (1987) Australian Standard 2919-1987, Industrial Clothing. Sydney,
Standards Association of Australia.
Standards Australia (1990) Australian Standard 3765.1-1990, Clothing for Protection against
Hazardous Chemicals Part 1 Protection against General or Specific Chemicals. Sydney,
Standards Association of Australia.
Standards Australia (1994) Australian Standard 1336-1994, Eye protection in the Industrial
Environment. Sydney, Standards Association of Australia.
Standards Australia/Standards New Zealand (1992) Australian/New Zealand Standard 1337-
1992, Eye Protectors for Industrial Applications. Sydney/Wellington, Standards Association
of Australia/Standards Association of New Zealand.
Standards Australia/Standards New Zealand (1994) Australian/New Zealand Standard 2210-
1994, Occupational Protective Footwear. Sydney/Wellington, Standards Association of
Australia/Standards Association of New Zealand.
Standards Australia/Standards New Zealand (1998) Australian/New Zealand Standard
2161.2-1998, Occupational Protective Gloves, Part 2: General Requirements. Sydney,
Standards Association of Australia.
FULL PUBLIC REPORT 1 November, 2000
NA/773 26/28
Thomas O N (1997) BPA-BDPP: Twenty-Eight Day Repeated Dose Oral (Gavage) Toxicity
Study In The Rat, Project No. 106/018, Safepharm Laboratories Limited, Derby.
Thompson P W (1997) BPA-BDPP: Reverse Mutation Assay "Ames Test" Using Salmonella
typhimurium and Escherichia coli, Project No. 106/019, Safepharm Laboratories Limited,
Derby.
Tremain S P (1997) Determination of Vapour Pressure, Project No. 106/012, Safepharm
Laboratories Limited, Derby.
Wetton P M (1997a) BPA-BDPP: Acute Toxicity to Daphnia magna, Project No. 106/022,
Safepharm Laboratories Limited, Derby.
Wetton P M (1997b) BPA-BDPP: Acute Toxicity To Rainbow Trout (Oncorhynchus
mykiss), Project No. 106/021, Safepharm Laboratories Limited, Derby.
FULL PUBLIC REPORT 1 November, 2000
NA/773 27/28
Attachment 1
The Draize Scale for evaluation of skin reactions is as follows:
Erythema Formation Rating Oedema Formation Rating
No erythema 0 No oedema 0
Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1
Well-defined erythema 2 Slight oedema (edges of area well-defined 2
by definite raising
Moderate oedema (raised approx. 1 mm) 3
Moderate to severe erythema 3
Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4
and extending beyond area of exposure)
The Draize scale for evaluation of eye reactions is as follows:
CORNEA
Opacity Rating Area of Cornea involved Rating
No opacity 0 none 25% or less (not zero) 1
Diffuse area, details of iris clearly 1 slight 25% to 50% 2
visible
50% to 75% 3
Easily visible translucent areas, details 2 mild
of iris slightly obscure
Greater than 75% 4
Opalescent areas, no details of iris 3
visible, size of pupil barely discernible moderate
Opaque, iris invisible 4 severe
CONJUNCTIVAE
Redness Rating Chemosis Rating Discharge Rating
Vessels normal 0 none No swelling 0 none No discharge 0 none
Vessels definitely 1 Any swelling above 1 slight Any amount different 1 slight
injected above normal slight normal from normal
More diffuse, deeper 2 mod. Obvious swelling with 2 mild Discharge with 2 mod.
crimson red with partial eversion of lids moistening of lids and
individual vessels not adjacent hairs
Swelling with lids half-
easily discernible
closed 3 mod. Discharge with 3 severe
Diffuse beefy red 3 severe moistening of lids and
Swelling with lids half- hairs and considerable
closed to completely 4 severe area around eye
closed
IRIS
Values Rating
Normal 0 none
Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight
No reaction to light, haemorrhage, gross destruction 2 severe
FULL PUBLIC REPORT 1 November, 2000
NA/773 28/28
|