Registration Dossier
Registration Dossier
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EC number: 641-487-5 | CAS number: 40150-92-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- No single animal data provided; Relevant details on materials and methods not provided
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-ol
- Cas Number:
- 40150-92-3
- Molecular formula:
- C12 H18 O
- IUPAC Name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-ol
- Details on test material:
- No further data provided
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D - Coconut Oil fractionated
- Concentration / amount:
- 30 %
- Day(s)/duration:
- not applicable
- Route:
- other: epicutaneous (cover not specified)
- Vehicle:
- other: Alembicol D - Coconut Oil fractionated
- Concentration / amount:
- 100%
- Day(s)/duration:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous (cover not specified)
- Vehicle:
- other: Alembicol D - Coconut Oil fractionated
- Concentration / amount:
- 35% and 70%
- Day(s)/duration:
- 24h
- No. of animals per dose:
- 20
- Details on study design:
- The shaved skin of twenty female Dunkin/Hartley guinea pigs was treated with the test
material by intradermal injection (as a 30% v/v preparation in Alembicol D, with and
without Freund's oomplete adjuvant) and then by topical application of neat test material
seven days later.
Two weeks after the final induction administration, animals were challenged with test material as a 35% and 70% v/v preparations in Alembicol D, at separate skin sites, for a 24 hour dermal exposure. - Challenge controls:
- Twenty female animals treated only with vehicle and Freund's complete adjuvant served as controls. The sites of exposure were examined for erythema and edema 24, 48 and 72 hours following removal of test material.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: not specified
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Reading:
- other: not specified
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 35% and 70%
- No. with + reactions:
- 10
- Total no. in group:
- 18
- Remarks on result:
- other: 2 animal´s responses were judged as inconclusive and not included
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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