Registration Dossier
Registration Dossier
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EC number: 939-379-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 500 mg of the test substance were semiocclusively applied once to the intact skin of 3 female adult New Zealand White rabbit (3-4.3 kg) for an exposure period of 4 hours. Evaluation of skin irritation was made until day 7 according to Draize
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bayplast Gelb 5G
- IUPAC Name:
- Bayplast Gelb 5G
- Details on test material:
- Bayplast Gelb 5G
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shorn
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
Any other information on results incl. tables
no erythema and no edema was evident (score = 0 at any time point)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
500 mg of the test substance were semiocclusively applied once to the intact skin of 3 female adult New Zealand White rabbit (3-4.3 kg) for an exposure period of 4 hours. Evaluation of skin irritation was made until day 7 according to Draize. No erythema and no edema was evident (score = 0 at any time point).
Bayplast Gelb 5G = Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexe was 'not irritating to the skin' (exposure period: 4 hrs).
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