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Key value for chemical safety assessment

Additional information

In vitro gene mutation in bacteria:

Krul, 2002 was conducted according to OECD 471 guideline under GLP conditions.

The test substance Tetraoctyltin [CAS # 3590-84-9] was examined for mutagenic activity in the bacterial reverse mutation test using the histidine-requiring Salmonella typhimurium strains TA 1535, TA 1573, TA 98, and TA 100, the tryptophan-requiring Escherichia coli strain WP2 uvrA, and a liver fraction of Arochlor 1254 -induced rats for metabolic activation (S9 -mix).

The test substance was dissolved in DMSO. A dose range finding test was performed with TA 98 both in the absence and presence of S9 -mix with ten different concentrations of the test substance, ranging from 0.3-5000 µg/plate. Tetraoctyltin was not toxic at any concentration.

In the main bacterial reverse mutation test, five different concentrations were tested ranging from 62-5000 µg/plate. Negative controls (solvent) and positive controls were run simultaneously with the test substance.

Tetraoctyltin was not toxic to any strain at any concentration, as was evidenced by the absence of a decrease in the mean number of revertant colonies.

It is concluded that Tetraoctyltin was not mutagenic under the conditions employed in this study.

Mouse micronucleus test:

De Vogel, 2003 was conducted according to OECD 474 guideline under GLP conditions.

The test substance Tetraoctylstannane (TTOT) [CAS# 3590-84-9] was examined for its mutagenic potential in a bone marrow micronucleus test in mice. The study consisted of a dose-range finding acute toxicity test carried out with male and female mice and a main micronucleus test with male mice only.

Results of the dose range finding acute toxicity test indicated that there were no sex differences in response and that a limit dose of 2000 mg/kg-bw could be tolerated. Male mice were chosen for the main study and doses of 2000, 1000 and 500 mg/kg-bw were adopted.

For the main micronucleus test, animals were treated once by gavage with three graded dose levels of the test substance Tetraoctylstannane.

At both time points, 24 and 48 hours after treatment, the number of micronucleated polychromatic erythrocytes (MPE) per 2000 polychromatic erythrocytes (PE) were counted for each mouse. The mean number of MPE per 2000 PE, at dose levels of 2000, 1000 and 500 mg/kg-bw of Tetraoctylstannane, were not statistically significantly different than the vehicle control mean. Therefore, the test substance Tetraoctylstannane, at dose-levels up to 2000 mg/kg-bw, was not genotoxic to bone marrow cells in mice.

At 24 and 48 hours after treatment , the mean number of polychromatic erythrocytes (PE) per erythrocyte (E) in mice, at all treatment levels of Tetraoctylstannane, were not statistically significantly different from the mean of the vehicle control mice. Therefore, treatment with Tetraoctylstannane, at dose-levels up to 2000 mg/kg-bw, was not cytotoxic to the bone marrow of mice.

These data support the conclusion that, under the conditions used in this study, the test substance Tetraoctylstannane did not produce chromosomal damage or damage to the mitotic spindle apparatus in the bone marrow target cells of mice.


Short description of key information:
Reliable results for in vitro and in vivo genetic toxicology have been provided by Krul, 2002 and de Vogel, 2003 respectively. Both studies have been rated as 1 for reliability according to the criteria set-out by Klimisch, 1997. De Vogel, 2003 was conducted according to OECD 474 guideline and Krul, 2002 was conducted according to OECD 471 guideline.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based upon the information presented in these tests the registered substance does not meet the criteria for classification according to Directive 67/548/EEC or Regulation (EC) 1272/2008.