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
- Study period:
- 1970s-1980s
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Test for primary skin irritants
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- IUPAC Name:
- Water
- Reference substance name:
- 9-[(2-hydroxyethyl)amino]-9-oxononanoic acid
- Cas Number:
- 242132-61-2
- Molecular formula:
- C11H21NO4
- IUPAC Name:
- 9-[(2-hydroxyethyl)amino]-9-oxononanoic acid
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved: intact or scarified (4 cm2)
- Vehicle:
- water
- Remarks:
- 30% (distilled water)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4h
- Observation period:
- 4h, 24h, 48h, 72h
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- other: 4h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- other: 4h
- Score:
- 0.17
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- 24 h
- Score:
- 0.17
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- other: 4h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- other: 4h
- Score:
- 0.17
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- scarified skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Conclusions:
- CLP criteria not met
- Executive summary:
According to scoring for skin lesions no alteration was reveled. No irritant activity was found.
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