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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:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Possible origin of the skin sensitization potential of isoeugenol and related compounds
Author:
Barratt MD and Basketter DA
Year:
1992
Bibliographic source:
Contact Dermatitis vol 27, 98-104

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study performed previous to the recommendation of choosing the LLNA as first option

Test material

Reference
Name:
Unnamed
Type:
Constituent

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
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction injection: 2%
Induction patch: 50%
Challenge patch: 10%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction injection: 2%
Induction patch: 50%
Challenge patch: 10%
No. of animals per dose:
10
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
2%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Group:
test group
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
rechallenge
Group:
test group
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria