Registration Dossier
Registration Dossier
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EC number: 205-516-1 | CAS number: 141-97-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Molecular formula: C6H10O3
- Physical state: Colourless liquid
- Storage condition of test material: Room temperature, protected from light
Constituent 1
- Specific details on test material used for the study:
- - Batch-no: 15.07.83
- Storage: at 22°C in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- number of animals: 3
- Weight at study initiation: 2800-3200 mg/kg
- Housing: single housing
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml test item was applied on a 2.5 x 2.5 cm patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation 30 minutes, 24 hours, 48 hours and 72 hours after removal of patch
- Number of animals:
- 3 animals
- Details on study design:
- no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Neither erythema nor oedema were observed throughout the study.
- Other effects:
- none
Any other information on results incl. tables
The results are summarized below:
Observation |
Mean values over 24, 48 & 72 hours |
Mean value |
||
No.1 |
No.2 |
No.3 |
||
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was classified as non-irritant to rabbit skin
- Executive summary:
The study was performed in 1983 under GLP according to OECD 404. Three albino rabbits were treated semi-occlusive with 0.5 ml test item was applied on a 2.5 x 2.5 cm patch. Observation times were 24, 48 and 72 hours after removal of the patch. Neither erythema nor oedema were observed in this study. Therefore, EAA is not irritating to rabbit skin.
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