Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
1. Identification of the substance/preparation and of the company/undertaking
NGAL ELISA Kit (KIT 036) (for research use only)
Catalog No: KIT 036
The NGAL ELISA Kit (KIT 036) is intended by BioPorto Diagnostics to measure human NGAL in tissue fluids (e.g.
plasma, serum or urine), tissue extracts or culture media in in vitro research activities only ?not for use in
diagnostic procedures and not the therapeutic use.
BioPorto Diagnostics A/S Phone: +45 4529 0000 Responsible person: Camilla Recke
Grusbakken 8 Fax: +45 4529 0001 Title: QA & RA Manager
DK-2820 Gentofte Email: info@bioporto.com Direct email: cr@bioporto.com
Denmark Web: www.bioporto.com
Emergency telephone: 112 (Europe)
2. Hazards identification
Only the kit component 2 5x Sample Diluent Conc. contains a hazardous reagents present in an amount that
qualifies the products as hazardous according to Directive 67/548/EC. This component is labeled harmful (Xn).
This pertains to contact with skin and if swallowed. The 5x Sample Diluent Conc. is harmful to aquatic organisms
and may cause long-term adverse effects in the aquatic environment.
According to EU regulations, no danger labeling is necessary for the diluted solution or all other kit components.
However exposure to large amounts and/or ingestion can potentially be hazardous.
NGAL Antibody
TMB Substrate
Kit component
Solution Conc.
Calibrator 1-8
Stop Solution
Diluent Conc.
12x8 coated
Microwells +
Biotinylated
streptavidin
5x Sample
25x Wash
Frame
NGAL
HRP-
3a-g 7 8
4
1 5 6
Hazard to man 2
Harmful by inhalation X X X
Harmful in contact with skin and if swallowed X X X
Danger of cumulative effects X
Risk of percutaneous absorption. X X X X X
Risk of sensitization of skin. X X X X X X X
Hazard to the environment
Harmful to aquatic organisms, may cause long-term adverse effects X X X (X) (X)
3. Composition/information on ingredients
The kit contains the following components: 12x8 coated Microwells + Frame, 5x Sample Diluent Conc., NGAL
Calibrators 1-8, 25x Wash Solution Conc., Biotinylated NGAL Antibody, HRP-streptavidin, TMB Substrate and
Stop Solution.
Only the kit component 2 5x Sample Diluent Conc. contains a hazardous reagent in an amount that requires
labeling. The contents in the components of ingredients listed as hazardous are given below:
Classification Classification
Component Ingredient Concentration CAS# EC#
(pure ingredient) (kit component)
2 5x Sample Diluent Conc. Sodium azide 0.25% (w/v) 26628-22-8 247-852-1 Tx; R28, R38 Xn; R21/22,
R52/53
N; R50/53
NA
NGAL Calibrator 1-8 0.05% (w/v)
3a-g
3a-g NGAL Calibrator 1-8 Recombinant NGAL produced in 0-0.0000001% - - NA, Biologic NA
non-hazardous E. coli bacteria (w/v)
and subsequently purified
25x Wash Solution Thimerosal 0.038% 54-64-8 200-210-4 Tx; R26/27/28, R33 NA
4
Conc. N; R50/53
Biotinylated NGAL Bronidox L (5-bromo-5- 0.2% (w/v) 30007-47-7 250-001-7 Xn; R22,R38 NA
5
Antibody nitro-1,3-dioxane 10% in
propylene glycol)
HRP-streptavidin 0.2% (w/v) NA
6
TMB Substrate 3,3?5,5? <0.05% (w/v) in 54827-17-7 259-364-6 Xn; R22 NA
7
tetramethylbenzidine H2O N;R51/53
8 Stop Solution Sulfuric acid 0.5 mol/L 7664-93-97 231-639-5 C; R35 NA
Issued: 2008-04-15
Printed: 15-04-2008 09:03 Page 1 of 6
Revised: 2008-04-15
Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
4. First aid measures
First aid personnel should ensure self protection.
After inhalation: Immediately remove the casualty from exposure and move to fresh air. If
breathing stops, immediately apply mechanical ventilation and apply an
oxygen mask if available. Arrange medical treatment.
After skin contact: Wash off with plenty of water. Remove contaminated clothing. If necessary
arrange medical treatment.
After eye contact: Rinse out with plenty of water with the eyelids held wide open. Arrange
medical treatment.
Immediately make casualty drink plenty of water, induce vomiting (not if acid
After swallowing:
is ingested and never in an unconscious patient). Immediately arrange
medical treatment.
5. Fire-fighting measures
Data for kit component solutions. Not for individual ingredients.
Suitable extinguishing media
Use water spray, dry sand, carbon dioxide or foam depending on the surrounding materials and equipment.
Special risks
Non-combustible. Ambient fire may liberate hazardous vapors. The following may develop in event of fire: sulfur
oxides, mercury vapors, nitrous gases or nitrogen oxides.
6. Accidental release measures
Person-related precautionary measures
Do not inhale aerosols. Immediately change contaminated clothing.
Environmental-precautionary measures
Do not allow to enter sewerage system. Contain spill.
Procedures for cleaning/absorption
Take up with liquid-absorbent material. Forward for disposal. Clean up and disinfect affected area.
7. Handling and storage
Handling
Cannot be stored indefinitely. Expiry date is printed on labels.
General good laboratory practice should be maintained. Handle calibrators and unknown samples as potentially
infectious.
Take care to keep workplace clean and dry. The substances used should not be present at the place of work in
quantities above those required for carrying out the work. Do not leave containers open. Avoid general contact by
handling. Compatible materials: glass, plastic.
Storage
Store components in the box with the lids tightly closed. Store all components at 2-8癈.
Specific use
The product is intended for research use only.
Intended for professional use only.
8. Exposure controls/personal protection
Data for kit components solutions (not for individual ingredients).
Personal protective clothing
Protective clothing should be selected specifically for the working place, depending on concentration and
quantity of the hazardous substances handled.
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Printed: 15-04-2008 09:03 Page 2 of 6
Revised: 2008-04-15
Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
Respiratory protection
Required only in unintentional release of the substance.
Eye protection
Required.
Skin protection
Required. Wear laboratory coat and protective gloves. The glove material must be sufficient impermeable and
resistant to the substance. Check the tightness before wear. Protect the skin. The following material is suitable
for protective gloves: Nitrile rubber.
General protective and hygienic measures
Foods and beverages should not be consumed in the vicinity of the work area. Wash hands before work breaks
and on finishing the work.
9. Physical and chemical properties
Data for kit component solutions (not for individual ingredients)
Clear to yellow solutions, odorless
Appearance:
pH: Neutral except for Stop Solution (pH ~0.6)
Boiling point: NA
Flash point: NA
Flammability: NA
Explosive properties: NA
Oxidizing properties: NA
Vapor pressure: NA
Relative density: NA
Solubility: Soluble in water
Viscosity: NA
Vapor density: NA
Evaporation rate: NA
Additional parameters: NA
10. Stability and reactivity
Stability: Stable. However note expiry date printed on labels. Store at 2-8癈 and replace the components at this
temperature at the end of the working procedure.
Conditions to avoid: Heating above room temperature, freezing.
Materials to avoid: Generally use only clean glass and plastic suitable for laboratory use for handling the kit
components.
Note that individual ingredients are incompatible with strong oxidizing agents, alkaline metals, alkaline
compounds, ammonia, alkaline earth metals, (strong) acids, strong bases, metals, metal alloys, combustible
compounds, organic solvents, halogenates, permanganates, reducing agents, heavy metals, metallic salts,
dimethylsulfate/acid, dichloromethane, carbon disulfide.
Dangerous reactions: In the case of fire see chapter 5.
Further information: Note that Stop Solution contains sulfuric acid (H2SO4) and has a corrosive effect.
11. Toxicological information
Because of the small size of the containers and the low concentrations of hazardous ingredients, the
toxicological risks are minor.
Toxicological experiments have not been done on the kit components.
Issued: 2008-04-15
Printed: 15-04-2008 09:03 Page 3 of 6
Revised: 2008-04-15
Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
The following toxicological information is for the hazardous ingredients in pure form from ChemIdplus:
Sodium azide (ingredient in 5x Sample Diluent Conc. and NGAL Calibrators)
Sodium azide is a cytochrome oxidase inhibitor which is a nitridizing agent and an inhibitor of terminal oxidation
(Merck Index, 12th ed). Sodium azide acts as a fungicide, bactericide, herbicide, insecticide and nematocide.
Acute toxicity
After inhalation: Severe irritation of mucous membranes, respiratory tract. Possible damages:
pulmonary edema. Latency time until onset of action.
After swallowing: Irritations of mucous membranes in the mouth, pharynx, esophagus and
gastrointestinal tract.
After skin contact: Slight irritations. Danger of skin absorption.
After eye contact: Eye irritation test (rabbit): Slight irritation of the eye.
Systemic effects of azide exposure: CNS disorders (tremor on long-term exposure), cardiovascular failure,
tachycardia, drop in blood pressure, coughing, dyspnea, spasms, headache, dizziness, nausea, vomiting,
collapse, unconsciousness.
Animal toxicity data: LD50 (dermal, rabbit): 20 mg/kg, LD50 (oral, rat): 27 mg/kg.
Human toxicity data: An oral dose of 0.71 mg/kg caused general anesthetic effect and depressed activity as
well as changed activity in the kidney, ureter and bladder.
An oral dose of 29 mg/kg caused increased intracranial pressure, change in pulse rate and acute pulmonary
edema.
An oral dose of 129 mg/kg caused coma and death within 4 hours.
Further toxicological information: No teratogenic effect in animal experiments.
Thimerosal (ingredient in 25x Wash Solution Conc.)
Thimerosal is a topical antiseptic used on skin and mucous membranes. It is also used as a preservative in
pharmaceuticals. Thimerosal acts as an anti-infective agent, fungicide, bactericide, disinfectant, wood
preservative, and germicide.
Acute toxicity
After inhalation: Irritation and/or damage of the mucous membranes of respiratory tract.
After swallowing: Irritation of the mouth, throat, and other tissues of the gastrointestinal system
can occur.
After skin contact: Irritation of the skin. Danger of skin absorption.
After eye contact: Eye irritation test (rabbit): Slight irritation of the eye.
Systemic effects of thimerosal exposure
Acute: Metallic taste, nausea, vomiting, abdominal pain, bloody diarrhea, intestinal burns, glottal edema,
aspiration pneumonia, drop in blood pressure, cardiac arrhythmia, circulatory collapse and renal failure.
Chronic: Inflammation of the mouth with loss of teeth and mercurial line. The principal signs manifest themselves
in the CNS (impaired speech, vision, hearing and sensitivity, loss of memory, irritability, hallucinations, delirium).
Animal toxicological data: LD50 (oral, rat): 75 mg/kg.
Human toxicological data: An oral dose of 29 mg/kg caused degenerative changes in the brain, anorexia and
changes in motor activity.
An oral dose of 83 mg/kg caused coma, gastritis, renal tubular failure, dermatitis, gingivitis, delirium,
polyneuropathy and respiratory failure.
Further toxicological information: Danger of cumulative effects. Long-term exposure leads to damage of the
nervous system.
Bronidox L (ingredient in Biotinylated NGAL Antibody and HRP-streptavidin):
Few data are available.
Acute toxicity
After inhalation: May be harmful after inhalation and irritate the respiratory tract.
After swallowing: Harmful if swallowed
After skin contact: Irritation of the skin. Danger of skin absorption.
After eye contact: May cause eye irritation.
Issued: 2008-04-15
Printed: 15-04-2008 09:03 Page 4 of 6
Revised: 2008-04-15
Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
Effects of Bronidox L exposure: Behavioral (tremor), behavioral (convulsions or effect on seizure threshold),
behavioral (excitement), skin and appendages (after systemic exposure: dermatitis, other)
Animal toxicological data: LD50 (oral, mouse): 590 mg/kg, LD50 (oral, rat): 455 mg/kg.
Human toxicological data: No data available.
12. Ecological information
Sodium azide
Highly toxic to aquatic organisms. May cause long-term adverse effects in the aquatic environment. Forms toxic
mixtures in water, dilution measures notwithstanding. Herbicidal effect. Nematocidal effect.
NCLASS data:
Toxicity: Proposed 0.1 mg/L < L(E)C50 <1 mg/L
Degradation: Readily degradable = No
Bioaccumulation: Log Pow = NA, BCF = NA
ECOTOX data
Algeal toxicity: Dunaliella tertiolecta (green algae) EC50: 2 mg/L (24 h), Macrocystis pyrifera (giant kelp) EC50: 1.1
mg/L (24 h)
Crustacean toxicity: Daphnia pulex (water flea) EC50: 4.2 mg/L (48 h)
Fish toxicity: Lepomis macrochirus (bluegill) LC50: 0.7 mg/L (96 h)
Plant toxicity: Lemna minor (duckweed): 64 ug/L (24 h)
Insect toxicity: Pteronarcys californicus (stonefly) LC50: 9 mg/L (96 h)
Invertebrate toxicity: Microregma sp. (cilated protozoa): 3 mg/L
Mollusc toxicity: Mytilus californianus (mussel): EC50: 13.2 mg/L (96 h)
Thimerosal
Highly toxic for aquatic organisms. May cause long-term adverse effects in the aquatic environment. Hazard for
drinking water supplies.
NCLASS data
Toxicity: L(E)C50 < 1mg/L
Degradation: Readily degradable = No
Bioaccumulation: Log Pow = NA, BCF = NA
ECOTOX data
Fish toxicity: Lepomis macrochirus (Bluegill) LC50: 110 mg/L (24 h)
Bronidox L
No data available
Further ecological information
Do not allow to enter waters, waste water or soil.
Due to the small size of the containers and the low concentrations of hazardous ingredients, ecological risks are
minor.
13. Disposal considerations
Product: Must be disposed in compliance with the respective national regulations.
Packaging: Must be disposed in compliance with the respective national regulations.
14. Transport information
No special transport regulations
ADR (road)/ RID (rail): NA
IMDG (sea): NA
ICAO / IATA (air): NA
Issued: 2008-04-15
Printed: 15-04-2008 09:03 Page 5 of 6
Revised: 2008-04-15
Material Safety Data Sheet (MSDS)
According to Annex II of EC Regulation No. 1907/2006 concerning REACH
15. Regulatory information
Classification: Risk phrases:
R21/22: Harmful in contact with skin and if swallowed.
2 5x Sample Diluent Conc.
R52/53: Harmful to aquatic organisms and may cause long-term
adverse effects in the aquatic environment.
Safety Phrases:
S35: Dispose of containers and unused contents in a safe way
Xn = Harmful
S45: In case of accident or if you feel unwell, seek medical advice
No danger labeling is required for immediately (show the labeling where possible)
the diluted solution S61:. Avoid release into the environment.
No other kit component contains a hazardous ingredient in an amount that requires identification and labeling
according to EC directives.
16. Other information
For research use only.
Read instructions for use before using the product. Observe the general safety regulations when handling
chemicals. Good laboratory practice is the best preventive measure to avoid hazards.
The information above is believed to be accurate and represents the best information currently available to us.
Data are predominantly from the NCLASS, Ecotox and ChemIdplus databases and the Merck Index.
Prepared by: ______ CR __________________ Date: __2008-04-14___
QA & RA Manager, BioPorto Diagnostics A/S
Issued: 2008-04-15
Printed: 15-04-2008 09:03 Page 6 of 6
Revised: 2008-04-15
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