Hexan-1-ol

Carcinogenicity

Description of key information

The tumour promoting activity of hexan-1-ol by dermal application on mice for an exposure period of 60 weeks was reported in a study by Sice (1966, rel;4). The conclusion was that hexan-1-ol did not exhibit any tumour promoting effects under the test conditions. In addition there has been various repeated dose studies on both hexan-1-ol and other structurally related alcohols; none of which have indicated the presence of treatment related hyperplastic or neoplastic lesions.

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 adverse effect observed

Species:

mouse

Quality of whole database:

Rel 4 study

Justification for classification or non-classification

On the basis of the lack of effects seen in repeated dose studies using hexan-1-ol and other structurally analogous alcohols, no classification is required for carcinogenicity according to Regulation (EC) No 1272/2008 (CLP).

Additional information

Based on the weight of evidence of lack of carcinogenic effects that have been observed across the category, together with the lack of any genotoxic effects and the lack of tumour promoting effects in study described above, it is concluded that there is no scientific justification to commission any studies to further examine this carcinogenicity end point for hexan-1-ol.

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