Registration Dossier
Registration Dossier
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EC number: 287-625-4 | CAS number: 85566-16-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Toxicity Profile Tridecanols
- Author:
- BIBRA
- Year:
- 1 988
- Bibliographic source:
- Unpublished data submitted to BIBRA by a member company
Materials and methods
- Principles of method if other than guideline:
- In a group of 20 guinea pigs an unspecified number of intradermal injections of a 1% mixture of the test substance in liquid paraffin were followed 1 week later by the topical application (probably covered, 48h) of a similar 5% solution. A topical challenge with 0.1% of the same mixture in liquid paraffin (probably covered, 48 h) given 2 weeks later produced no reactions.
- GLP compliance:
- not specified
- Type of study:
- intracutaneous test
Test material
- Reference substance name:
- Isotridecan-1-ol
- EC Number:
- 248-469-2
- EC Name:
- Isotridecan-1-ol
- Cas Number:
- 27458-92-0
- Molecular formula:
- C13H28O
- IUPAC Name:
- Isotridecanol (reaction product of dodecene)
- Details on test material:
- - Name of test material (as cited in study report): 70% branched chain primary isomers of tridecanol and 30% pentadecanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- induction: intradermal: 1%, topical: 5%;
challenge: 0.1%
Challengeopen allclose all
- Route:
- other: epicutaneous, probably covered
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- induction: intradermal: 1%, topical: 5%;
challenge: 0.1%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections of a 1% mixture of the test substance in liquid paraffin were followed 1 week later by the topical application (probably covered, 48h) of a similar 5% solution.
B. CHALLENGE EXPOSURE
A topical challenge with 0.1% of the same mixture in liquid paraffin (probably covered, 48h) was given 2 weeks later.
Results and discussion
Any other information on results incl. tables
The topical challenge with 0.1% of the test mixture in liquid paraffin produced no reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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