Registration Dossier
Registration Dossier
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EC number: 410-510-9 | 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)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: none
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Max. score:
- 1
- Remarks on result:
- other: max. duration: 48h. Max. value at end of observation period:0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0.7
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration 72h. Max value at end of observation period:0 (related to all animals)
- Other effects:
- The application sites where stained yellow in all animals for up to 3 days after application. The staining did not, however, obscure the assessment of the erythema.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating under the above test conditions.
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