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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 chemical
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.