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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
The likely route of human exposure is inhalation. According to Annex VIII 8.6.1 column 1 the likely route of human exposure must be regarded for a short-term repeated dose toxicity study (28 days). The likely route of human exposure is inhalation. Thus a short-term repeated dose toxicity study (28 days) for the dermal route is not required. According to Annex IX 8.6.2 column 1 the likely route of human exposure must be regarded for a sub-chronic (90 days) toxicity study. The likely route of human exposure is inhalation. Thus a sub-chronic toxicity study (90 days) for the dermal route is not required. A long-term repeated toxicity study (>/= 12 months) is not proposed as none of the conditions of Annex X 8.6.3. column 2 are met.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion