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EC number: 222-813-1 | CAS number: 3618-72-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The sensitization potential was evaluated according to the procedure provided by Imperial Chemical Industries Ltd, after the ear/flank method of Stevens (1967) (Stevens MA, 1967. Use of the albino Guinea pig to detect the skin sensitizing ability of chemicals. Brit. J. Ind. Med. 24:189-202).
Induction: Approximately 0.1 mL per ear per day of test substance in a suitable solvent was applied daily to the outer surface of the ears with a glass Pasteur pipette, of six of the group of 10 Guinea pigs on Days 0, 1 and 2. The other 4 animals acted as controls and remained untreated.
Challenge: Immediately before the challenge applications on Day 7, an area approximately of 110 x 50 mm on each flank of all test animals was clipped free of hair. The challenge application was then carried out over a range of 3 concentrations of test substance in a logarithmic series. The dilutions followed sequentially down the series, including the induction concentration which was the highest level, i.e. 10, 1 and 0.1% in dimethylformamide (DMF). Approximately 0.2 mL of each solution was applied, again with a glass Pasteur pipette, to separate 10 mm diameter circular areas. Each concentration was applied to both flanks of all 10 Guinea pigs with the highest concentration posterior to the next lower concentration. On Day 8, any erythema present at the challenge sites was rated on a 5 point scale. Only erythematous responses displayed by the pre-treated (test) animals in excess of that displayed by the controls was considered to denote sensitization. That present in the controls was deemed simple primary irritation. - GLP compliance:
- no
- Type of study:
- other: Guinea pig ear/flank method of Stevens (1967)
- Justification for non-LLNA method:
- The study was conducted before the requirements for LLNA were published.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tuck, Rayleigh, Essex, UK
- Females (if applicable) nulliparous and non-pregnant: [not specified]
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 250-350 g
- Housing: Plastic-coated metal cages, 60 x 90 x 25 cm
- Diet (e.g. ad libitum): Labsure RGP pellet
- Water (e.g. ad libitum): yes
- Acclimation period: at least 6 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 50 +/- 10 R.H.
- Photoperiod (hrs dark / hrs light): 12:12 - Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 3
- Adequacy of induction:
- not specified
- No.:
- #6
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 10, 1 and 0.1%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 4 controls
6 test animals - Details on study design:
- INDUCTION
Approximately 0.1 ml per ear per day of test substance in a suitable solvent was applied daily to the outer surface of the ears with a glass Pasteur pipette, of six of the group of 10 Guinea pigs on Days 0, 1 and 2. The other 4 animals acted as controls and remained untreated.
CHALLENGE
Immediately before the challenge applications on Day 7, an area approximately of 110 x 50 mm on each flank of all test animals was clipped free of hair. The challenge application was then carried out over a range of 3 concentrations of test substance in a logarithmic series. The dilutions followed sequentially down the series, including the induction concentration which was the highest level, i.e. 10, 1 and 0.1% in dimethylformamide (DMF). Approximately 0.2 ml of each solution was applied, again with a glass Pasteur pipette, to separate 10 mm diameter circular areas. Each concentration was applied to both flanks of all 10 Guinea pigs with the highest concentration posterior to the next lower concentration. On Day 8, any erythema present at the challenge sites was rated on a 5 point scale. Only erythematous responses displayed by the pre-treated (test) animals in excess of that displayed by the controls was considered to denote sensitization. That present in the controls was deemed simple primary irritation. Bodyweight and clinical signs were recorded regularly. - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10, 1 and 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was considered not to be sensitizing to Guinea pig.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance (in the form of blue grains, purity not given) according to the procedure provided by Imperial Chemical Industries Ltd, after the ear/flank method of Stevens (Brit. J. Ind. Med. 24:189 -202, 1967). In the induction phase, approximately 0.1 mL per ear per day of test substance in a suitable solvent was applied daily with a glass Pasteur pipette to the outer ear surface of six female Dunkin Hartley Guinea pigs on Days 0, 1 and 2. A further 4 animals acted as controls and remained untreated. Immediately before the challenge applications on Day 7, an area approximately of 110 x 50 mm on each flank of all test animals was clipped free of hair. The challenge application was then carried out over a range of 3 concentrations of test substance in a logarithmic series. The dilutions followed sequentially down the series, including the induction concentration which was the highest level, i.e. 10, 1 and 0.1% in dimethylformamide (DMF). Approximately 0.2 mL of each solution was applied, again with a glass Pasteur pipette, to separate 10 mm diameter circular areas. Each concentration was applied to both flanks of all 10 Guinea pigs with the highest concentration posterior to the next lower concentration. On Day 8, any erythema present at the challenge sites was rated on a 5 point scale. Only erythematous responses displayed by the pre-treated (test) animals in excess of that displayed by the controls was considered to denote sensitization. That present in the controls was deemed simple primary irritation. Bodyweight and clinical signs were recorded regularly. No responses were provoked in any of the animals at any of the test concentrations. Animals showed normal bodyweight changes throughout the study and remained in good health. Under the study conditions, the test substance was considered not to be sensitizing to Guinea pig (Lightowler, 1978).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the test substance (in the form of blue grains, purity not given) according to the procedure provided by Imperial Chemical Industries Ltd, after the ear/flank method of Stevens (Brit. J. Ind. Med. 24:189 -202, 1967). In the induction phase, approximately 0.1 mL per ear per day of test substance in a suitable solvent was applied daily with a glass Pasteur pipette to the outer ear surface of six female Dunkin Hartley Guinea pigs on Days 0, 1 and 2. A further 4 animals acted as controls and remained untreated. Immediately before the challenge applications on Day 7, an area approximately of 110 x 50 mm on each flank of all test animals was clipped free of hair. The challenge application was then carried out over a range of 3 concentrations of test substance in a logarithmic series. The dilutions followed sequentially down the series, including the induction concentration which was the highest level, i.e. 10, 1 and 0.1% in dimethylformamide (DMF). Approximately 0.2 mL of each solution was applied, again with a glass Pasteur pipette, to separate 10 mm diameter circular areas. Each concentration was applied to both flanks of all 10 Guinea pigs with the highest concentration posterior to the next lower concentration. On Day 8, any erythema present at the challenge sites was rated on a 5 point scale. Only erythematous responses displayed by the pre-treated (test) animals in excess of that displayed by the controls was considered to denote sensitization. That present in the controls was deemed simple primary irritation. Bodyweight and clinical signs were recorded regularly. No responses were provoked in any of the animals at any of the test concentrations. Animals showed normal bodyweight changes throughout the study and remained in good health. Under the study conditions, the test substance was considered not to be sensitizing to Guinea pig (Lightowler, 1978).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of an in vivo study in Guinea pigs, no classification for skin sensitization is required for the test substance according to CLP (EC 1272/2008) criteria.
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