Registration Dossier
Registration Dossier
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EC number: 692-946-1 | CAS number: 649747-80-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short summary available. (analytical purity and composition of test substance not specified)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lack of details on test substance, documentation insufficient
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Hexyl laurate
- EC Number:
- 251-932-1
- EC Name:
- Hexyl laurate
- Cas Number:
- 34316-64-8
- IUPAC Name:
- hexyl laurate
- Details on test material:
- - Name of test material (as cited in study report): [Trade name] (lauric hexylate)
- Physical state: oily liquid
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Treatment group: mean - 433 g (20 animals), control group: mean - 476 g (10 animals)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 1% in Vaseline
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 1% in Vaseline
- No. of animals per dose:
- Control group: 10 animals
Treatment group: 20 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- no data
B. CHALLENGE EXPOSURE
- Exposure period: 24 hours - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- Clinical observations:
- percievable reddening, reversible within 24 hours
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. Clinical observations: percievable reddening, reversible within 24 hours.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- Clinical observations:
- percievable reddening, reversible within 24 hours
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. Clinical observations: percievable reddening, reversible within 24 hours.
Any other information on results incl. tables
No individual data given. However, the experimental and control animals reacted to the retreatment qualitatively identical with percievable reddening of the parts of the skin treated, this quickly subsided and 24 hours after removal of the patch no further reaction was visible. The same observations are by experience made where vaseline is used as the medium for retreatment.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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