Registration Dossier
Registration Dossier
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EC number: 904-153-2 | CAS number: -
Carcinogenicity
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
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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