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Skin sensitisation

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Administrative data

skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
2 (reliable with restrictions)

Data source

Reference Type:

Materials and methods

Principles of method if other than guideline:
the minimum skin irritation concentration of the test substance was determined in an open epicutaneous test;
induction: 6-8 guinea pigs/dose group, undiluted or 30, 10, 3, 1, 0.3, 0.1, 0.03, 0 % solution, 21 d;
challenge: d 21 and d 35
GLP compliance:
Type of study:
open epicutaneous test

Test material

In vivo test system

Test animals

guinea pig

Results and discussion

Any other information on results incl. tables

The test item was tested as such as well as dissolved in different solvents, etc., at concentrations of 30, 10, 3, 1, 0.3, 0.1, and 0.03 % in order to establish a dose-response curve making it possible to determine the minimal irritating and the maximal tolerated concentrations on an 'all or none' basis.

Induction period: On day 0, 0.1 ml of each undiluted compound and of itsprogressively diluted solutions was applied to an area of measuring 8 cm²on the clipped flank skin of 6 to 8 guinea pigs per concentration group,using 4 to 6 groups for each compound. The applications were repeateddaily for 21 days, always using the same skin site. The application sitewas left uncovered and the reactions were read 24 h after each application.

Challenge procedure: to determine wheather or not allergic contactdermatitis was induced, all groups of guinea pigs previously treated for21 days as described above as well as 6 to 8 untreated controls for each compound,were tested on days 21 and 35 on the contralateral flank with the same compound. The test substance was was negative.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test substance was tested as such and in several solvents at different concentration between 0.03 and 30%.

The maximum non irritant and the minimal irritating concentrations were determined.

To determine wheather or not allergic contact dermatitis was induced, all groups of guinea pigs were tested with the same compound at the minimal irritating concentration and at some lower non irritant concentrations. The test substance was negative in this test

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