Registration Dossier
Registration Dossier
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EC number: 201-877-4 | CAS number: 89-04-3
Carcinogenicity
Administrative data
Description of key information
A carcinogenicity study may be required in accordance with REACH Regulation 1907/2006, Annex X, Section 8.9.1 of Column 1, Annex X. It is proposed to waive the need to conduct this study on the basis that available information indicate no concerns for carcinogenicity.
Key value for chemical safety assessment
Carcinogenicity: via oral route
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
A carcinogenicity study may be required in accordance with REACH Regulation 1907/2006, Annex X, Section 8.9.1 of Column 1, Annex X. It is proposed to waive the need to conduct this study on the basis of:
1) Negative findings in tests for gene mutation / mutagenicity.
2) Molecular modelling studies performed by Kambia et al. (Kambia N, Renault N, Dilly S, Farce A, Dine T, Gressier B Luyckk M, Brunet C and Chavatte P. Molecular modelling of phthalates – PPARs interactions. Journal of Enzyme Inhibition and Medicinal Chemistry, 23(5): 611–616, 2008) indicate that TOTM, a structural analogue of the registered substance derived from a C8 -branched alcohol rather than a C8 -linear alcohol, is not able to fit into PPARα and PPARγ binding sites due to its larger size relative to the corresponding phthalate ester, implying that any predicted activity may not actually be able to occur.
With these considerations it is concluded that there is sufficient evidence to justify the non-classification of the registered substance for carcinogenicity.
Additional information
A carcinogenicity study may be required in accordance with REACH Regulation 1907/2006, Annex X, Section 8.9.1 of Column 1, Annex X. It is proposed to waive the need to conduct this study on the basis of:
1) Negative findings in tests for gene mutation / mutagenicity.
2) Molecular modelling studies performed by Kambia et al. (Kambia N, Renault N, Dilly S, Farce A, Dine T, Gressier B Luyckk M, Brunet C and Chavatte P. Molecular modelling of phthalates – PPARs interactions. Journal of Enzyme Inhibition and Medicinal Chemistry, 23(5): 611–616, 2008) indicate that TOTM, a structural analogue of the registered substance derived from a C8 -branched alcohol rather than a C8 -linear alcohol, is not able to fit into PPARα and PPARγ binding sites due to its larger size relative to the corresponding phthalate ester, implying that any predicted activity may not actually be able to occur.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
