Z-85

Endpoint summary

Additional information

Read-across to properties ofCAS No.: 886584-31-2 (Butanedioic acid, 2,3-dihydroxy-, 2-ethylhexyl diesters, (2R,3R)-rel-) is applicable based on the similarity in structure and physico-chemical properties.

The justification for read-across is presented in Section 13 Assessment reports- Read-across justification

Gene Mutation Assays

A Bacterial Reverse mutation Assays (Ames test) was performed according to the OECD 471 test guideline with the substance. The study (2007) was selected as a key study. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains in both experiments, with any dose of the test material, either with or without metabolic activation. The study results indicate that the substance does not induce gene mutations in bacteria, whereas all positive control chemicals (with and without metabolic activation) induced a significant increase in the number of of colonies.The substance is therefore considered as non-mutagenic according in the Ames test.

A mammalian cell gene mutation assay in L5178Y cells was performed according to the OECD 476 test guideline with the substance. The study (2013) was selected as a key study. No significant increases in the frequency of mutant colonies was recorded, either in the absence or presence of metabolic activation.

The substance does not induce gene mutations in L5178Y cells under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of mutations.The substance is therefore considered as negative for inducing gene mutations in L5178Y cells under the activation and non-activation conditions used in this assay.

 

Chromosomal aberration

The clastogenic potential of a read-across substance was determined using an in vitro chromosome aberration test in Human lymphocyte cells, which measures the potential of a substance to increase the incidence the of structural chromosome aberrations in cultured cells.

None of the test substance dose levels, up to the cytotoxicity limit, either with or without metabolic activation, induced significant increases in the frequency of cells with aberrations in either of two experiments. The read-across substance does not induce structural aberrations in the chromosomes of HL cells under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of aberrant cells.The substance is therefore considered as negative for inducing chromosomal mutations in HL cells under the activation and non-activation conditions used in this assay.

Justification for selection of genetic toxicity endpoint
The studies were conducted to OECD Guidelines. There were no deviations and the studies met the validation criteria. The chromosome aberration study was performed on a read-across substance.

Short description of key information:
- Ames Test 2007 (OECD 471, GLP, K, rel. 1): non mutagenic up to 5000 µg/plate in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 & WP2uvrA-
- Human lymphocyte chromosome aberration test 2007 (OECD 473, GLP, K, rel. 1, but K2 for the purposes of read-across): non clastogenic up to cytotoxic limit
- Gene mutation assay in mouse lymphoma L5178Y cells 2013 (OECD 476, GLP, K rel. 1): non mutagenic up to maximum cytotoxic limit

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for mutagenicity according to the Regulation (EC) No. 1272/2008 including the ATP2.

Self classification:

Based on the available data, no additional classification for mutagenicity is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.