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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The dataset for covering the endpoint in vitro genotoxicity compiles 30 studies performed with different non- as well as surface-treated forms of the substance and BET values ranging from 30 to 420 m²/g. Several different test methods were used, and all studies meet the criteria of Klimisch score 1 or 2.

15 Bacterial reverse mutation assays were carried out according to OECD TG 471 or similar protocols, both with and without metabolic activation, of which 14 under GLP. None of these studies occasioned positive results.

Using mammalian cells, 7 chromosome aberration assays were carried out according to OECD TG 473 or similar protocols, both with and without metabolic activation and under GLP, except for 1 supporting study. None of these studies evidenced any clastogenic potential.

Gene mutation testing on mammalian cells was carried out in 2 studies according to EPA OPP 84-2 and OECD TG 490 and under GLP. No positive effects were detected in both studies.

One additional test for Unscheduled DNA Synthesis (UDS) carried out, under GLP, with rat primary hepatocytes according to OECD TG 482 yielded negative results.

Genetic toxicity in vivo

Description of key information

The in vivo genotoxicity potential of the substance was evaluated in 5 studies launched from 1974 to 2013 with materials having BET range from 175 to 349 m²/g. All these studies meet the criteria of Klimisch score 2.

A rodent dominant lethal test (similar to OECD guideline 478), was performed in 1974 on the substance and no chromosome aberration was detected. A Mammalian bone marrow chromosome aberration was performed according to OECD 475 and no genotoxicity was detected. No clastogenic activity has been observed in the chromosome aberration test in Chinese hamster ovary (CHO) cells.

In vivo tests on somatic cells (a mammalian erythrocyte micronucleus test according to OECD guideline 474) and in vivo comet assay were performed on a form of surface treated SAS in 2013.-No genotoxicity and no increased DNA damage, respectively, were detected.

Additional information

Justification for classification or non-classification

Available studies did not identify any potential towards genotoxicity. According to Annex I of the Regulation (EC) 1272/2008 (table 3.5.1) and GHS (Globally Harmonized Classification System), the test substance requires no classification and has no mandatory label requirement.