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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information


Currently viewing:

Administrative data

Description of key information

Genotoxicity assays on the target substance Polyol TD and its suitable read-across partners 2 -ethylpropane1,3 -diol (DMP) and 5 -Ethyl-1,3 -dioxane-5 -methanol (CTF) were performed according to OECD Guidelines and showed a lack of genotoxicity. In addition, repeated dose toxicity studies did not show any carcinogenic effects. No carcinogenicity data is available for the target substance. Given the negative in vitro genotoxicity results and a lack of pre-neoplastic lesions and/or hyperplasia in repeated dose and developmental toxicity studies, there are no indications that the target substance is carcinogenic. Therefore, according to Column 2 of Annex X of REACH Regulation a carcinogenicity study is not necessary, and a waiver was developed to cover the carcinogenicity endpoint..

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
carcinogenicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to Column 2 of Regulation (EC) No. 1907/2006, Annex X, a carcinogenicity study may be required if the substance has a widespread dispersive use, or there is evidence of frequent or long-term human exposure and the substance is classified as mutagen category 2, or there is evidence from the repeated-dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Based on the available data, the target substance would not classify as a mutagen. No hyperplasia and/or pre-neoplastic lesions were identified in repeated dose and developmental toxicity studies. Therefore, classification for carcinogenicity in accordance with CLP Regulation 1272/2008 is not warranted.

Additional information