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Toxicological information

Skin sensitisation

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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:
1988
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Unpublished data submitted to BIBRA by a member company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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 70% branched chain primary isomers of tridecanol and 30% pentadecanol

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