Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
01 - 07 2001
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

GLP compliance:
yes
Type of study:
guinea pig maximisation test

Results and discussion

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
A discrete, moderate or intense erythema (grade 1, 2 or 3) was noted in 3/20, 10/20 and 2/20 animals respectively. An oedema persisted in 2/20 animals. Crusts were noted in 7/20 animals which were important enough to mask scoring of erythema in 3 of them.
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under conditions of the test (Magnusson & Kligman) there were delayed contact hypersensitivity in 85% onf the guinea pigs.