Registration Dossier
Registration Dossier
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EC number: 226-643-9 | CAS number: 5445-19-2
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
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
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:
- Methyl 2-bromohexanoate
- EC Number:
- 226-643-9
- EC Name:
- Methyl 2-bromohexanoate
- Cas Number:
- 5445-19-2
- Molecular formula:
- C7H13BrO2
- IUPAC Name:
- methyl 2-bromohexanoate
- 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: 2.65 - 2.87 Kg
- Housing: Suspended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): Free access
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:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hpurs
- Number of animals:
- 3 Male
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm cotton gauze patch
- Type of wrap if used: Surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton woll soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and Eschar Formation and Oedema Formation
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- > 0 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Material considered to be moderate irritant
- Irritant / corrosive response data:
- Well defined erythemia and very slight to slight oedema were noted at all treated skin sites 1, 24, 48 and 72 hours after patch removal.
No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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