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EC number: 222-102-6 | CAS number: 3349-08-4
- 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
read across to nickel sulphate (CAS 7786-81-4): skin sensitising cat 1, H317
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to IUCLID section 13 for justification of read across.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Interpretation of results:
- other: The test substance did cause dermal contact sensitization in female albino guinea pigs.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to April 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Guinea pig maximization test
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA is not applicable for use in evaluating skin sensitization since this methodology provides false negative results for nickel as a known human skin sensitizer (due to differences in the toll receptors in mice used in the LLNA and humans).
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA, USA.
- Age at study initiation: young adult
- Weight at study initiation: 345-350 g
- Housing: individually housed in wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: controlled, details not reported - Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 mL of 1.0 % w/v NiSO4 in distilled water
0.1 mL of Freunds Complete adjuvant (FCA)
0.1 mL of 1.0 % w/w NiSO4 in 50 % w/v (FCA)
0.3 mL of 5.0 % NiSO4 in distilled water for 48 hours - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Challenge was performed on both flanks and ventral surface and occluded for 24 hours at concentrations of 0.2 mL of 1.0 % w/v NiSO4 in distilled water.
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
0.1 mL of 1.0 % w/v NiSO4 in distilled water
0.1 mL of Freunds Complete adjuvant (FCA)
0.1 mL of 1.0 % w/w NiSO4 in 50% w/v (FCA)
0.3 mL of 5.0 % NiSO4 in distilled water and occluded for 48 hours
B. CHALLENGE EXPOSURE
Challenge was performed on both flanks and ventral surface and occluded for 24 hours at concentrations of 0.2 mL of 1.0 % w/v NiSO4 in distilled water.
Erythema and edema scored according to Draize et al. 1944. - Challenge controls:
- Induction: 0.1 mL of propylene glycol, 0.1 mL of FCA in distilled water, or 0.1 mL of 1.0 % w/v proylene glycol in 50 % w/v FCA.
Challenge: 0.2 mL of propylene glycol - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
- Positive control results:
- 1-chloro-2,4-dinitrobenzene did cause dermal contact sensitization in female albino guinea pigs.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Interpretation of results:
- other: The test substance did cause dermal contact sensitization in female albino guinea pigs.
- Conclusions:
- 10 of 10 guinea pigs exhibited skin reactions after challenge exposure with the test substance. Therefore the substance was concluded to be sensitising to skin.
Referenceopen allclose all
Mean erythema score at 24 and 48 hours for NiSO4 were 1.1 and 1.0, respectively.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No data on the substance itself is available. Therefore, read across to nickel sulfate (CAS 7786-81-4) was applied. Data were obtained from the ECHA disseminated Dossier of the substance.
A Guinea pig maximization test similar to OECD Guideline 406 was conducted with nickel sulfate. 10 female Guinea pigs were therefore tested. 1-chloro-2,4-dinitrobenzene served as positive control. For induction, the animals were exposed to the following concentrations: 0.1 mL of 1.0 % w/v test substance in distilled water, 0.1 mL of Freunds Complete adjuvant (FCA),0.1 mL of 1.0 % w/w test substance in 50% w/v (FCA) and 0.3 mL of 5.0 % test substance in distilled water. The test sites were occluded for 48 hours. Challenge was performed on both flanks and the ventral surface of the animals under occlusion for 24 hours at concentrations of 0.2 mL of 1.0 % w/v NiSO4 in distilled water. As a result, all animals of the test substance group showed skin reactions at the first and second reading. The test substance was concluded to be sensitising to skin.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data on skin sensitisation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the substance is considered to be classified for skin sensitisation, Cat. 1, H317 (may cause an allergic skin reaction) under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.
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