Registration Dossier
Registration Dossier
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EC number: 293-262-2 | CAS number: 91053-00-8 A complex combination of hydrocarbons obtained from distillation of the butadiene-free C4 fraction of a naphtha steam-cracking process. It consists predominantly of olefinic hydrocarbons having carbon numbers of C8, C12, C16 and C20 and boiling in the range of approximately 95°C to 120°C (203°F to 248°F).
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: GLP compliant, guideline study, no restrictions, fully 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- tributene
- IUPAC Name:
- tributene
- Reference substance name:
- C12-monoolefin, mixture of isomers
- IUPAC Name:
- C12-monoolefin, mixture of isomers
- Reference substance name:
- Trimebutine
- EC Number:
- 254-309-2
- EC Name:
- Trimebutine
- Cas Number:
- 39133-31-8
- Molecular formula:
- C22H29NO5
- IUPAC Name:
- 2-(dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Tributene, C12-monoolefin, mixture of isomers
- Physical state: Colourless liquid
- Analytical purity: About 99%
Constituent 1
Constituent 2
Constituent 3
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 Thomas GmbH, Biberach
- Age at study initiation: Not reported
- Weight at study initiation: 2.1-2.2 kg
- Housing: Individually in stainless steel cages
- Diet: K4 complete feed for rabbits (Ssniff Spezialfutter GmbH, D-4770 Soest) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20±1°C
- Humidity: 60±5%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light):
IN-LIFE DATES: From: 17 September 1986 To: 01 October 1986
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 cm3
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: mull patch (2.5 x 2.5 cm) covered with polyethylene film (6 x 6 cm), held with an elastic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Irritation index
- Basis:
- mean
- Remarks:
- according to VCI notes German Chemical Industry's Association safety data sheet
- Time point:
- other: 1,24,48,72 hours
- Score:
- 5.92
- Remarks on result:
- other: 5.92/8.0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- according to Appendix VI of 6th amendment (79/831/EEC)
- Time point:
- other: Not specified
- Score:
- 3.33
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- according to Appendix VI of 6th amendment (79/831/EEC)
- Time point:
- other: Not specified
- Score:
- 2.56
Any other information on results incl. tables
Well-defined erythema (extending beyond application area) and severe oedema present in all 3 rabbits 1 hour after application ended. Moderate/severe to severe erythema with eschar formation persisted in all animals up to the 6 day reading and eschar was still present in 2 animals at the final 14 day reading. The degree of oedema gradually reduced and none persisted in any animal at the 9 day reading.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Tributene was strongly irritant (irritation index 5.92/8) to the skin of male rabbits.
- Executive summary:
Tributene was strongly irritant (irritation index 5.92/8) to the skin of male rabbits when the test material was applied under occlusive conditions. The mean erythema and oedema scores (according to Appendix VI of the 6th amendment (79/831/EEC)) were 3.33 and 2.56 respectively.
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