Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

No data available on registered substance.

Non carcinogenic. No test is proposed because of:

- clear absence of genotoxic potential of the registered substance in standard assays (this excludes genotoxic carcinogenesis)

- absence of marked organ/tissue toxicity in available repeated-dose or reproductive toxicity studies (this does not sugget non-genotoxic carcinogenesis)

- absence of carcinogenic potential of the closely related substance 2-ethyl hexanol, precursor used in synthesis of registered substance, in rat (24 months) and mouse (18 months), as assessed by FDA and EPA.

Key value for chemical safety assessment

Additional information

No data available on registered substance.

No test is proposed because:

  • Genotoxic potential of the registered substance has been excluded in a standard test battery: Ames test (with limited reliability), chromosomal aberration assay (reliable) and mouse lymphoma assay (reliable); this was further confirmed in a mammalian cell transformation assay which was non-guideline but may be considered as a carcinogenicity screening assay (reliability not assessable).
  • No marked organ/tissue toxicity was noted in available repeated-dose or reproductive toxicity studies. In general the observed toxicity was limited to reduced weight gain. This does not sugget non-genotoxic carcinogenesis which may occur due to, e.g., prolonged cell stimulation and/or cytotoxicity.
  • The closely related substance 2-ethyl hexanol (NB: the synthesis precursor of the registered substance) was studied for carcinogenic potential in rat (24 months) and mouse (18 months). Both FDA and EPA concluded that it was not carcinogenic. Corresponding reviews are attached.

Justification for classification or non-classification

See discussion. Not classified based on data on the registered substance and on a closely related substance.