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:
- weight of evidence
- Study period:
- March 30, 1979 - April 6, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This in vivo study has been performed before the adoption of OECD 404, using US test standards. As the conditions under which the study was performed were more severe than prescribed by OECD 404 (24 hours occlusive exposure instead of 4 hours semi-occlusive exposure), it is still regarded as reliable information for assessing the skin irritation hazard of the substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Code of Federal Regulations 21, Part 191.1 (g) (2), 191.11
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Test material form:
- other: aqueous solution
- Details on test material:
- - Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- See section "Any other information on materials and methods incl. tables" for the available data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: see section "Any other information on materials and methods incl. tables"
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required
- Amount / concentration applied:
- TEST MATERIAL (applied as such)
- Amount applied on scarified area: 0.5 mL
- Amount applied on unscarified area: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours
- Number of animals:
- 3
- Details on study design:
- See section "Any other information on materials and methods incl. tables"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: effects were reported on the intact skin sites (mean erythema score of 1 at removal of the patch), which fully reversed within 48 hours. No oedema effects were observed. Results indicate minimal irritation.
- Conclusions:
- In an in vivo study performed similar to Code of Federal Regulations 21, Part 191.1 (g) (2), 191.11, before the adoption of OECD 404, the skin irritation potential of the substance (solid content: 36-38%) was investigated. The 3 rabbits were exposed to 0.5 mL of the test material for 24 hours under occlusive conditions. Effects were only reported directly after patch removal, with a very slight intensity, which fully reversed within 48 hours.
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