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Key value for chemical safety assessment

Additional information

In vitro studies:

Ames test - In the key study for in vitro genetic toxicity (Machado, 1997, report number: 17865-0-409R) 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 to a supporting substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9) 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.

In vivo:

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. A reliability rating of 1 according to the criteria of Klimisch, 1997.


Short description of key information:
There are 2 key endpoints required for in vitro genetic toxicity:

Ames test - The results of the Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay indicate that, under the conditions of this study, in both an initial and a confirmatory assay. The test article did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from AroclorTM-induced rat liver (S9). No cytotoxicity was observed up to 10,000 µg/plate with the Salmonella tester strains or with WP2uvrA in either the presence or absence of S9 mix. Test article precipitate was observed on the plates at 5.00 µg/plate.

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:
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.

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.