Registration Dossier

Administrative data

sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a sub-chronic toxicity study (90 days) does not need to be conducted because the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited
Justification for type of information:
Data from the Episkin reconstructed human epidermis model indicated that the substance was non-irritant and non-corrosive to skin. In addition, an acute dermal application study on the read across substance aluminum, benzoate C16-18 fatty acid complexes in rats tested up to the maximum exposure of 2000 mg/kg b.w. showed no dermal toxicity. The read across substance aluminum, benzoate C16-18 fatty acid complexes was also shown to be non-sensitising in a Mouse Local Lymph Node Assay. Consequently, further studies on the potential for dermal toxicity of this substance are unlikely to provide additional information, thus the Annex IX requirement for a subchronic study is waived in accordance with Annex XI.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion