Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

According to REACh Regulation (Annex VIII, section 8.5.3. second column) the acute toxicity study by the dermal route dose not need to be conducted as systemic effects in in vivo skin irritation and skin sensitization studies were not observed for TVCH. During the acute toxicty study by the oral route at high doses of 3980 mg/kg and above, transient narcotic effects were observed warranting a classification for specific target organ toxicity following single exposure, category 3 (STOT SE 3). However, significant toxic effects of relevance to human health after single exposure that would warrant a classification for STOT SE 1 or 2 were not observed with TVCH.
Thus, it is concluded that the acute toxicity study by the dermal route can be waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion