Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There is not enough available data for this endpoint for CAS: 96152-43-1, therefore studies from supporting, structurally similar substances have been used as for read-across purposes to address some endpoints.

In vitro studies

Ames test - In this key study for in vitro genetic toxicity (Dakoulas, 2010) the study was conducted according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) and GLP. A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997.

Mouse lymphoma - In this key study for in vitro genetic toxicity (Wininger et al, 1985, report number: SOCAL 2322) there was no guideline specified, however it was considered to be comparable to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test). The study was conducted in line with GLP. The reliability rating for this study is 1, however this is being used as read across as there was not enough available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997.

In vivo study

In the key study for in vivo genetic toxicity (Ivett, 1997, Corning Hazleton report number: 17865-0-455CO) the study was conducted according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test). The study was conducted in line with GLP. The reliability rating for this study is 1, however this is being used as read across from a supporting substance (Phenol, tetrapropenyl-, sulfurized, calcium salts CAS No. 68855-45-8) as there was no available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997.


Short description of key information:
There are 2 key endpoints available to fulfil requirements for in vitro genetic toxicity:
Ames test
The test material was tested in the histidine-deficient strains of Salmonella typhimurium TA98, TA100, and TA102 and in the tryptophan-deficient strain of Escherichia coli WP2 uvrA at dose levels of 0.033 to 3.33 mg/plate with and without metabolic activation provided by Aroclor-induced rat liver S-9. The test material was suspended in 25% Pluronic 127 (w/w in ethanol). The suspension was miscible with the top agar. It was not cytotoxic at any concentration tested. Under the conditions tested, the test material was not mutagenic to TA98, TA100, TA102, or E. coli WP2 uvrA.

Mouse lymphoma
The test material was tested in the L5178Y TK+/- Mutagenicity Screen with and without S-9 metabolic activation. The cultures with activation were tested at concentrations ranging from 75 µg/ml to 275 µg/ml; cultures without activation were tested at concentrations ranging from 60 µg/ml to 110 µg/ml. The results indicated that the test material did not induce a significant increase in the mutant frequencies of cultures tested either with or without metabolic activation. Under the conditions tested the test material was not mutagenic in this screen.

In vivo genotoxicity:
Based on the results of the dose selection study, the maximum tolerated dose was estimated as >5000 mg/kg. The test article did not induce a statistically significant increase in micro-nuclei in bone marrow polychromatic erythrocytes under the conditions of this assay and is considered negative in the mouse micronucleus assay.

Overall conclusions are that the materials of this category (and the REgistration material) are negative for genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results for the key parameters chosen for genetic toxicity were negative and so the criteria set out in Directive 67/548/EEC and also Regulation (EC) no 1272/2008 do not apply, therefore classification for genetic toxicity was not considered to be necessary.