Registration Dossier
Registration Dossier
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EC number: 206-761-7 | CAS number: 373-02-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel di(acetate)
- EC Number:
- 206-761-7
- EC Name:
- Nickel di(acetate)
- Cas Number:
- 373-02-4
- Molecular formula:
- Ni(CH3CO2)2
- IUPAC Name:
- nickel di(acetate)
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- As cited in paper: nickel acetate, Lot #: PTL N103
Constituent 1
- Specific details on test material used for the study:
- As cited in paper: nickel acetate, Lot #: PTL N103
Test material form: paste (semi-solid, amorphous; gel)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Female young adult non-pregnant and nullliparous guinea pigs were received from Robinson Services Inc. Animals were housed individually in suspended stainless steel cages with mesh floors and enrichment (e.g. toys) placed in each cage).
Room temperature: 12-21 degrees C
Humidity: 30-33%
Air changes: 13/hour
Photoperiod: 12-hour light/dark cycle
Acclimation period: 12 days
Food: Harlan Teklad Global High Fiber Rabbit Diet #2031
Water: Filtered tap water
Contaminants: none known- tested regulalrly adn results available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of test substance on 1 inch x 1 inch square gauze pad applid to 6 cm2 area of skin on each animal.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes, and 24, 48, and 72 hours
- Number of animals:
- 3
- Details on study design:
- Test animals were exposed to nickel acetate as a dry paste for 4 hours followed by obervations ofo up to 72 hours to detect irritation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: All
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reactions
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- None of the 3 animals tested demonstrated irritation from the application of nickel acetate at any observation times.
Applicant's summary and conclusion
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER
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