Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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: study conducted according to OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1982
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- other: aqueous solution
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Weight at study initiation: 2.0 - 2-3 kg
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM:
Erythema/eschar formation as well as edema formation were scored according to a 4-graded scoring system (0-3), respectively.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 / 48 / 72 h
- Score:
- 2.55
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 / 48 / 72 h
- Score:
- 1.72
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- During the observation period, scar formation and detachments of skin as well as hardened skin were observed. Erythema formation had not fully disappeared in all animals at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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