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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 92/69, Annex V - Method B6 and OECD No. 406
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
25% w/w Interdermal injection; Topical application 100%. 50% and 100% Topical challenge.
Challenge
Concentration / amount:
25% w/w Interdermal injection; Topical application 100%. 50% and 100% Topical challenge.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

Any other information on results incl. tables

No clinical signs and no deaths related to treatment were noted during the study. After the first challenge application, a discrete or moderate erythema was noted in 4/5 of the control group. In the treated group, a discrete, moderate or intense erythema was noted in all animals. Dryness of the skin was observed in almost all the animals of both groups at the 48 -hr reading. After the second challenge application, at the 24 -hr reading, a discrete erythema was noted in 1/5 animals of the control group 1 and in 4/5 animals of the control group 3. In the treated group, a discrete or moderate erythema was observed in 1/9 animals and 3/9 animals, respectively. Dryness on the skin was observed in 4/9 animals of the treated group. The cutaneous reactions recorded in the animals of the treated group, which were of higher intensity and duration than those recorded in the animals of the control groups, were attributed to delayed contact hypersensitivity. The species and stain which were used showed a satisfactory sensitization response in 75% of the animals with Mercaptobenzothaizole.

Applicant's summary and conclusion

Executive summary:

Under our experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance Pseudo Kharismals Step 1 induces delayed contact hypersensitivity in 3/9 (33%) guinea-pigs.