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EC number: 205-597-3
CAS number: 143-28-2
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 (z)-octadec-9-enol 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 (z)-octadec-9-enol or structurally related alcohols (though reporting is limited in many cases). In addition, (z)-octadec-9-enol does not have any genotoxic effects.
Based on the weight of evidence, classification for
carcinogenicity is not required according to Regulation (EC) No 1272/2008.
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.
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.
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