Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

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

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.

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.