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Key value for chemical safety assessment

Additional information

Two studies on genetic toxicity are available for C16-18AS Na (CAS 68955-20-4). To assess the mutagenic potential on mammalian cells in vitro a read across to structurally related alkyl sulfate (AS) for weight-of-evidence approach, i.e. C12AS Na (CAS 151-21-3) was performed. The possibility of a read-across to other alkyl sulfates in accordance with Regulation (EC) No 1907/2006 Annex XI 1.5. Grouping of substances and read-across approach was assessed. In Annex XI 1.5 it is given that a read-across approach is possible for substances, whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS category show structural similarity. The most important common structural feature of the category members is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the members of the AS category in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS of the AS category have similar physico-chemical, environmental and toxicological properties, validating the read across approach within the category. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

in vitro mutagenicity in bacteria

There are two studies available addressing genetic toxicity for C16-18AS Na (CAS 68955-20-4).

In the first study, performed according to OECD Guideline 471, Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 1538 and TA 100 were treated with C16-18AS Na (CAS 68955-20-4) in presence and absence of metabolic activation. The tester strains TA 102 or E.coli were not used during the conduct of the study (Banduhn, 1992). In this study the dose range was 8, 40, 200, 1000 and 5000 µg/plate in the first experiment and 6.25, 25, 100, 400 and 1600 µg/plate in a second experiment (and the repetition of the second experiment). Results achieved with negative control (untreated and medium), vehicle (water) and positive controls were valid. Cytotoxicity was observed in presence and absence of metabolic activation at and above 200 µg/plate. No genotoxicity was observed.

in vitro genotoxicity in mammalian cells

The mutagenicity of C12AS Na (CAS 151-21-3) in a mammalian cell line was investigated similar to OECD guideline 476 using the mouse lymphoma L5178Y cells with and without metabolic activation (McGregor, 1988). The test concentrations were 3.125, 6.25, 10, 12.5, 20, 25, 30, 40, 50, 55, 60, 65, 70, 80 and 100 µg/mL without and 50, 55, 60, 65, 70, 75, 80, 85, 90 and 95 µg/mL with metabolic activation. Results achieved with the negative (untreated), vehicle (DMSO) and positive controls were valid. Cytotoxicity was observed in presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for C12AS Na (CAS 151-21-3).

in vivo genoticity

The potential of C16-18AS Na (CAS 68955-20-4, analytical purity 55%) to induce micronuclei in vivo was assessed in a study conducted according to OECD guideline 474 with CFW-1 mouse (Wallat, 1986). The test substance was administered via gavage at doses of 400, 2000 and 4000 mg/kg bw to 7 animals per sex and dose. Bone marrow was sampled 24 h (400 and 2000 mg/kg bw) and 24, 48 and 72 h (4000 mg/kg bw) after gavage. Results achieved with the vehicle (water) and positive controls were valid. No signs of toxicity were noted. As no increased numbers of micronuclei were observed in this micronucleus test the test substance was considered to be not clastogenic.

In conclusion, the substance did not show any genotoxic potential. This is supported by the conclusions of the HERA Draft report “AS are not genotoxic, mutagenic or carcinogenic…” and the conclusions of the SIDS initial assessment profile “Alkyl sulfates of different chain length and with different counter ions were not mutagenic in standard bacterial and mammalian cell systems [...]. There was also no indication for a genotoxic potential of alkyl sulfates in various in vivo studies on mice […].”

 

[1] SIDS initial assessment profile, (2007);
http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002);
http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf


Justification for selection of genetic toxicity endpoint
No study selected as all three studies were negative.

Short description of key information:
In vitro gene mutation:
Bacterial reverse mutation assay (Ames test / OECD guideline 471): negative
In vitro mammalian cell gene muatation assay (MLA / OECD guideline 476): negative
In vivo clastogenicity:
Mammalian Erythrocyte Micronucleus Test (MNT / OECD guideline 474): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.