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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
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 skin contact in production and/or use is not likely
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.5 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on available information. In addition to the oral route, the information required in sub-section 8.5.2 and 8.5.2 should be provided for at least one other route. The data via the oral route indicates that the acute oral toxicity LD50 < 2000 mg/kg bw. The data in an available inhalation (OECD TG 436) study indicates that the LC50 > 5.0 mg/L. Testing via the dermal route is not deemed required as sufficient information has been provided for the information requirement and exposure to humans via the dermal route is considered unlikely during use. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.4, July 2017) the study does not need to be conducted.

Data source

Materials and methods

Results and discussion

Clinical signs:
other:

Applicant's summary and conclusion