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Skin sensitisation

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skin sensitisation: in vivo (non-LLNA)
Data waiving:
study technically not feasible
Justification for data waiving:
Justification for type of information:
In accordance with Annex XI , Section 2 and Annex XI , Section1.1 the standard requirements for this study have been adapted.

The standard test for in vivo sensitisation is not technically feasible as it is not possible to paint the test substance on to the anterior surface of mouse ears.The test substance is an inorganic fibre that is not soluble and its physical form precludes standard application to mouse ears and therfore in accordance with Annex XI, Section 2 this test is not technically feasible.

Instead information requirements for this endpoint are fulfilled by human epidemiology data in accordance with annex XI, Section1.1. Human surveillance data is available for this substance which shows no sensitising effects in the work force; details are described in section 7.10.1

Data source

Materials and methods

GLP compliance:
Type of study:

Results and discussion

Applicant's summary and conclusion