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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
90 -days Dermal toxicity study does not have to be conducted on RDP based on available experimental information and exposure route considerations.
2 Acute Dermal toxicity studies are available on RDP. In both studies no toxicity was observed (LD50 > 2000 mg/kg) and the substance did not induce any signs of systemic toxicity on the rats. In addition, RDP was not irritant to skin or eye, and did not cause allergic skin reactions in the Skin sensitisation study. Dermal absorption of RDP is limited as indicated by series of toxicokinetic studies.
The main route of exposure for RDP is the oral route. Nevertheless, the personal precautions for users indicate explicitly the obligation for using protective rubber gloves while handling the substance.
Therefore, for the reasons stated above and since the study is costly and requires use of many animals, we believe that performing this study is not necessary and can be avoided

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion