Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) and Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) methyl esters

Endpoint summary

Additional information

Methanol:

In vitro studies:

Methanol has been examined in numerous tests including bacterial, mammalian and fungal test systems. Most studies failed to demonstrate mutagenic activity, with four exceptions: 1) in Salmonella tester strain TA 102, a questionable positive response was observed (DeFlora et al., 1984); 2) in a DNA damage and repair assay with E. coli WP strains (repair proficient and deficient types), the result was considered ambiguous (DeFlora et al. 1984b); 3) in a mouse-lymphoma assay, a significant increase in the mutation rate was reported at 7.9 mg/mL methanol (McGregor et al., 1985); and 4) in a test of mitotic chromosomal segregation in Aspergillus nidulans, a positive result was observed (Crebelli et al., 1989). All other studies produced consistently negative results (Shimizu et al., 1985; DeFlora, 1981; NEDO, 1987; Lasne et al., 1984).

In vivo studies:

The available in vivo assays are negative for mutagenicity and clastogenicity. Some of these assays were conducted under specific stress conditions using folate-deficient mice (Am. Petrol. Inst., 1991; Fu, 1996).

In conclusion, the majority of in vitro and in vivo assays on methanol are negative for mutagenicity and clastogenicity. However a few of the in vitro assays were positive or ambiguous (DeFlora et al., 1984a, 1984b; McGregor et al., 1985; Crebelli et al., 1989). The positive findings can not be evaluated since the available data base is limited.

Overall, the registered is considered to be not genetically toxic.

Short description of key information:

Methanol:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium negative except TA 102+S9 (ambiguous) (OECD 471)

Gene mutation (Mammalian cell gene mutation assay): V79 negative, L5178Y+S9 positive (both comparable to OECD 476)

Chromosome aberration (in vitro micronucleaus assay): V79 negative

DNA damage (Damage and repair assay in bacteria): E. coli positive

Genome mutation (Mitotic chromosomal segregation assay): A. nidullans positive

In vivo:

Chromosome aberration (Chromosomal aberration): primary lung cells negative

Chromosome aberration (Micronucleus assay): erythrocytes negative (similar OECD 474), primary lung cells negative

Chromosome aberration (Synaptonemal complex): pachytene spermatocytes negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results in the in vivo studies, methanol does not seem to be mutagenic. Furthermore, carcinogenicity studies indicated no evidence of a carcinogenic potential in rats and mice exposed to methanol. No need for classification.