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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Version / remarks:
OET (Klecak 1977)
Deviations:
not applicable
Principles of method if other than guideline:
OET (Klecak 1977)
GLP compliance:
no
Remarks:
study pre-dates the introduction of GLP
Type of study:
open epicutaneous test
Justification for non-LLNA method:
LLNA not available at the time of testing.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
Material: Linalyl Isobutyrate

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Challenge
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
No. of animals per dose:
One to six experimental groups and one control group of six to eight guinea pigs are used.
Details on study design:
Induction consisted of 21 daily open applications to the shaved flank of 6-8 guinea pigs per group. One to six experimental and one control group of six to eight guinea pigs ware used. Open challenge applications were made on days 21 and 35. Reactions were read at 24, 48 and 72 hours. No further details were provided.

Results and discussion

In vivo (non-LLNA)

Results
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Linalyl Isobutyrate was found to be non-sensitizing in the Open Epicutaneous test (OET) in the Guinea Pig.