Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

According to REACH Annex XI (weight of evidence), testing for sub-chronic dermal toxicity is not considered to be required. The UVCB is characterised by a high variability in content of individual constituents, whereas the constituents as such (or at least their elemental composition) are known. The human health hazard assessment is driven by the hazard assessment of the individual UVCB constituents. For most of the relevant constituents, toxicity data in the form of DNELs (and the required contextual information) is available from associated REACH registration files (for more information please refer to the DNEL section). In conclusion, since relevant DNELs could be made available, testing on repeated dose toxicity via dermal route is not considered to be required.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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