Alcohols, C12-15-branched and linear

Carcinogenicity

Description of key information

Although Column 2 of REACH Annex X requires a carcinogenicity study (required in Section 8.9.1) if the substance has a wide dispersive use, the weight of evidence across the category suggests that Alcohols C12-15 branched and linear is not carcinogenic. This is based on a large set of various types of repeated dose studies across the category which do not offer any evidence of treatment-related induction of hyperplasia / pre-neoplastic lesions for Alcohols C12-15 branched and linear or structurally related alcohols (though reporting is limited in many cases). In addition, Alcohols C12-15 branched and linear does not have any genotoxic effects.

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

Based on the weight of evidence, the data is waived as testing is not a scientifically necessary option for this endpoint.

Additional information

Several members of the category of the LCAAs have been tested as control substances in skin painting studies.

Even taking into account the limitations of these experiments, the data show that none of aliphatic alcohols

tested have a potential to induce local skin tumours upon repeated dermal application at or above the maximum

tolerated (irritant) dose. However, these data are unsuitable to assess properties such as co-carcinogenicity

or tumour promotion for this category. Most of the study protocols considered here have almost certainly

induced considerable local effects, however details of the irritation responses are limited and were reported

only in a few cases. Irrespective of the causative agent, irritation at the site of application is a

significant confounder in skin painting studies and its role in the tumour development of non-genotoxic

chemicals has been well established (for examples see Nessel et al., 1998, 1999; Argyris, 1985).

LCAAs are non-genotoxic and lack structural elements of concern for interaction with DNA (Ashby and Tenant,

1991). Together with the lack of response upon repeated application the skin painting studies LCAAs are

regarded to be of little concern regarding carcinogenicity.The large set of various types of repeated dose

studies across the category which do not offer any evidence of treatment-related induction of hyperplasia /

pre-neoplastic lesions for any of the structurally related alcohols (though reporting is limited in many

cases), and the lack of genotoxic effects demonstrated across the category, suggest that none of the category

members are likely to be carcinogenic.

Argyris T.S. 1985, Regeneration and the mechanism of epidermal tumor promotion. Crit Rev Toxicol: 14(3):211-

58.

Nessel, C.S., Freeman, J.L et al. 1999 The role of dermal irritation in the skin tumor promoting activity of

petroleum middle distillates. Toxicological Sciences 49: 48-55.

Nessel, C.S.; Priston, R.A.J.; et al. 1998 A comprehensive evaluation of the mechanism of skin tumorigenesis

by straight-run and cracked petroleum middle distillate

Toxicological Sciences 44: 22-31.