Registration Dossier
Registration Dossier
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EC number: 208-574-6 | CAS number: 533-68-6
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: Carried out in accordance with EOCD Guidelines for testing of Chemicals No. 404 "Acute Dermal irritation/Corrosion" and EEC method B4 Acute Toxicity (Skin Irritation)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl 2-bromobutyrate
- EC Number:
- 208-574-6
- EC Name:
- Ethyl 2-bromobutyrate
- Cas Number:
- 533-68-6
- Molecular formula:
- C6H11BrO2
- IUPAC Name:
- ethyl 2-bromobutanoate
- Test material form:
- other: Liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2 - 3.5Kg
- Housing: Suspended metal cages
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 3min, 1 & 4 hrs
- Observation period:
- 1, 24, 48 & 72 hrs
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 3.0
- Score:
- > 0 - < 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Material considered moderate irritant
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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