Registration Dossier

Diss Factsheets

Administrative data

short-term repeated dose toxicity: dermal
Data waiving:
other justification
Justification for data waiving:

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Repeated dose toxicity study via dermal route does not need to be performed since the physic chemical and toxicological properties do not suggest potential for a significant rate of absorption through the skin (see remarks on results).
According to the data requirements as outlined in Annexes VIII-IX, 8.6 column 2 of Regulation (EC) 1907/2006 a repeated dose toxicity study shall be via the most appropriate route of administration, having regard to the likely route of human exposure. The inhalation route is considered as the most appropriate route of exposure.