Registration Dossier
Registration Dossier
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EC number: 234-294-9 | CAS number: 11071-47-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, guideline study, adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Isooctene
- EC Number:
- 234-294-9
- EC Name:
- Isooctene
- Cas Number:
- 11071-47-9
- Molecular formula:
- C8H16
- IUPAC Name:
- 2-methylhept-1-ene
- Details on test material:
- Di-n-butene. According to the report's owners the substance di-n-butene can be classified as CAS 11071-47-9 (Isooctene)
Components: 18% n-Octene, 58% Methylheptene and 24% Dimethylhexene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian CHbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2-2.3 kg
- Housing: stainless steel cages
- Diet: K4 Alleindiat for rabbits ad libitum
- Water: tap water ad libitum
- Acclimatisation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20±1°C
- Humidity: 60±5%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 cm3
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours post treatment and then at 6, 8, 10 and 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: Gauze (2.5 x 2.5 cm) and then with polyethylene film (6 x 6 cm), bound on to the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (warm water)
- Time after start of exposure: 4 hours
SCORING SYSTEM: OECD method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 2.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Di-n-butene was irritating to rabbit skin after application of 0.5 cm3 test substance.
- Executive summary:
Following a single 4 hour application, Di-n-butene was irritating to rabbit skin after application of 0.5 cm3 test substance.
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