Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.2 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. Available in vivo (OECD TG 423) acute oral toxicity and in vivo (OECD TG 409) 28 day repeated dose toxicity (28d RDT) indicates that the substance is not acutely toxic; the oral LD50 is >2000mg/kg bw and the oral 28d RDT NOEAL is >=1000mg/kg bw. No systemic toxicity in skin sensitisation or irritation studies provides a definitive conclusion on the classification can be made. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion