Registration Dossier
Registration Dossier
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EC number: 208-574-6 | CAS number: 533-68-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Method designed to meet requirements of OECD Guidelines for the Testing of Chemicals No. 406 "Skin Sensitisation" and EEC method B6 Acute Toxicity (Skin Sensitisation)
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 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 300 - 450 g
- Housing: solid floor polypropylene 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1% & 5% v/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 1% & 5% v/v
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10% & 5% v/v in arachis oil BP
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Extreme sensitiser
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 10% & 5% v/v in arachis oil BP. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Extreme sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material produced a 100% (10/10) sensitisation rate and was classified as an extreme sensitiser
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