Registration Dossier
Registration Dossier
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EC number: 428-880-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro
The test material was examined for its mutagenic potential in the Ames Test conducted according to the OECD Guideline 471 (Safepharm Laboratories Ltd 1235/007, 1998). For this purpose the Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and the Escherichia coli strain WP2uvrA- were treated with the test material using the plate incorporation method, in triplicate, both with and without S9 mix. The dose range was determined in a preliminary toxicity assay and was set at 50 to 5000 µg/plate, using DMSO as vehicle. The mutagenicity test consisted of 2 experiments. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without S9 mix.
Conclusion: The test item was non-mutagenic in Salmonella typhiumurium and Escherichia Coli under the conditions of the study.
The clastogenic potential of the test material in human lymphocytes was tested in the chromosome aberration test according to the OECD Guideline 473 (Safepharm Laboratories Ltd 1235/055, 1999). Duplicate cultures of lymphocytes obtained from a healthy donor were treated with the test material and evaluated for chromosome aberrations in two experiments. In the first experiment (I), the dose levels selected for evaluation were 0 (vehicle control), 625, 1250 and 2500 µg/mL, both with and without S9-mix. In the second experiment (II), the dose levels selected for evaluation were 0 (vehicle control), 312.5, 625 and 1250 µg/mL, both with and without S9-mix. Positive control substances were ethylmethanesulphonate in absence of S9 mix and cyclophosphamide in presence of S9-mix. Cytotoxicity was assessed by determination of the mitotic index.
The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations in either the presence or absence of S9-mixing system in either of the 2 experiments conducted.
The vehicle controls had frequencies of cells with chromosome aberrations within the expected range, and the positive control treatments gave statistically significant increases in the frequency of cells with aberrations, thus confirming the suitability of the test system and conditions used.
Conclusion: The test item was not clastogenic to human lymphocytes under the conditions of the study.
The potential of Pigment Orange 79 (Strontium Salt) to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was tested according to the OECD Guideline 476 (BASF 50M0592/11X258, 2012). The test concentrations were 150, 300, 600, 1200, 2400, 3600, 4800 µg/mL. Testing was done in absence or presence of S9 mix. Positive control substances were ethylmethanesulphonate in absence of S9 mix and 7,12-dimethylbenzanthracene in presence of S9-mix. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the highest concentration tested, with and without S9 mix.The positive control substances both induced a distinct increase in mutant colonies and thus, confirmed the sensitivity of the test system and the activity of the S9 mix.
Conclusion: The test item was not mutagenic to the HPRT locus in V79 cells of the Chinese hamster under the conditions of the study.
Genetic toxicity in vivo
No data available.
Justification for selection of genetic toxicity endpoint
Valid guideline studies available.
Short description of key information:
The following reliable in vitro studies are available:
An in vitro Ames Test conducted according to OECD 471 revealed that the test material was not mutagenic in bacteria (Safepharm Laboratories Ltd 1235/007, 1998).
An in vitro chromosomal aberration test conducted according to OECD 473 revealed no clastogenic potential for the test material in human lymphocytes (Safepharm Laboratories Ltd 1235/055, 1999).
An in vitro hprt assay with Chinese hamster lung fibroblasts (V79) conducted according to OECD 476 was negative (Harlan 1450204, 2012).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for genetic toxicity is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for genetic toxicity is not warranted under Regulation (EC) No.1272/2008.
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