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Key value for chemical safety assessment

Additional information

Genetic Toxicity in vitro

In the study conducted by Thompson (1981), the test material, alkyl glycidyl ethers, were examined for their ability to cause genetic mutations when tested in strains of Salmonella typhimurium, specifically TA 98, TA 100, TA 1535, TA 1537 and TA 1538, in the presence and absence of metabolic activation. The test substance was tested at concentrations of 20.6, 61.7, 185.2, 555.5, 1667 and 5000 ug/plate. Based on the results of this study, the test susbtance induced a positive result when tested with and without metabolic activation. Under the conditions of the study and based on the results, the test substance should be considered to be a genotoxicity Category 2 mutagen and should have the signal word Warning and the hazard statement H341: Suspected of causing genetic defects, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as a Category 3 mutagen and should have the symbol Xn and the risk phrase R68 Possible risk of irreversible effects associated with it.

The supporting in vitro studies illustrated that the mutagenicity test gave positive results independent of the test system used.

Weight of evidence from published sources indicated that five assays based on the Ames test design all gave positive results for genotoxicity with or without metabolic activation. Investigations into induction of chromosomal changes were either positive or gave ambiguous results but none of the assays were clearly negative. The mouse lymphoma gene toxicity assay wasa also positive with or without metabolic activation. A number of other assays were also reported - covering sister chromatid exchange, SOS repair and a Comet assay, the results of all tests were indicative of positive genotoxic effects for glycidol.

Genetic Toxicity in vivo:

Glycidol was examined for its ability to cause toxicity when tested on male and female Cpb: WU : Wistar rats. Groups of 15 male rats were exposed to the test substance for 6 hours a day for 5 consecutive days at concentrations of 0, 40, 130 and 400 ppm. A positive control group of 6 rats was treated with intraperitoneal injection of 25 mg/kg body weight of methylmethane sulfonate. The rats were exposed via the inhalation route. Following exposure, each of the male rats were mated with 2 female virgin rats per week over a period of nine consecutive weeks. Observations made included general appearance and behaviuor, food intake and growth rate of the animal.

Under the conditions of this dominant lethal assay, the results obtained were positive. However, from the observations with methylmethane sulfonate, it can be concluded that the test system used was suitable to demonstrate dominant lethal effects.

Under the conditions of this study, the test substance should be classified as a Category 2 mutagen and have the signal word Danger and the hazard statement H340: May cause genetic defects in accordance with Regulation EC no. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as a Category 3 mutagen, with the symbol T and the risk phrase R46 associated with it.

The Dominant lethal test in rats (80 -0017 -DKM) led to ambiguous results, also the chromosome aberration test reported by Thompson and Gibson (1994). All reported MNT tests showed negative or weak positive reponse in mice and hamster after oral or peritoneal application. However, SLRL-Tests in Drosophila (Foureman etal, 1994 and Bishop etal, 1989) showed clear induced mutations by Glycidol.

Overall the in vivo results from a battery of tests indicated positive mutagenic potential for glycidol.


Short description of key information:
Several studies have been provided for the investigation of 2,3-epoxypropanol genetic toxicity in vitro and in vivo. 2,3-epoxypropanol was found to be positively genotoxic in the absence and presence of metabolic activation, in both in vitro and in vivo assays.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Genetic Toxicity in vitro:

Under the conditions of the key study and based on the results, the test substance should be considered to be a genotoxicity Category 2 mutagen and should have the signal word Warning and the hazard statement H341: Suspected of causing genetic defects, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as a Category 3 mutagen and should have the xymbol Xn and the risk phrase R68 Possible risk of irreversible effects associated with it.

Genetic Toxicity in vivo:

Under the conditions of this study, the test substance should be classified as a Category 2 mutagen and have the signal word Danger and the hazard statement H340: May cause genetic defects in accordance with Regulation EC no. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as a Category 3 mutagen, with the symbol T and the risk phrase R46 associated with it.