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DL-LACTONE CAS N°:79-50-5 - page 12 / 113

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OECD SIDS

DL-LACTONE

Studies in Humans No data available. Conclusion

The NOAEL for repeated dose toxicity is 200 mg/kg bw based on aggression and restlessness of females treated at 1000 mg/kg bw during part of the study period.

3.1.6 Mutagenicity Studies in Animals In vitro Studies

An Ames test in Salmonella typhimurium strains TA97, TA98, TA100, TA102 and TA1535 (OECD 471) gave negative results with and without metabolic activation. No toxicity was observed at the highest concentration tested (5000 µg/plate) (Gocke, 1999).

In vivo Studies

DL-Lactone at an oral dose of 1500 mg/kg bw did not induce any increase in the incidence of micronucleated polychromatic erythrocytes in an in vivo micronucleus test in mice performed according to OECD 474. Animals were treated with 0, 375, 750 and 1500 mg/kg bw (5/sex/treatment, single dose). The test groups treated with DL-lactone did not show any decrease in the ratio of normochromatic to polychromatic erythrocytes, which reflects a lack of toxic effects of DL-lactone on erythropoiesis (Meerts, 2002).

Studies in Humans No data available. Conclusion

Based on the outcome of the tests available, it can be concluded that DL-lactone does not possess mutagenic properties.

3.1.7 Carcinogenicity No data available.

3.1.8

Toxicity for Reproduction

For reproduction toxicity a combined 28-day reproduction/developmental toxicity screening study was available, performed according to OECD 422.

Studies in Animals Effects on Fertility/Developmental Toxicity

Rats (10/sex/treatment) were treated by gavage with 0, 40, 200 and 1000 mg/kg bw DL-lactone during 14 days prior to mating (1:1) and 14 days (males) or maximum 56 days (females) thereafter. Females were allowed to litter and to nurse their pups until day 4 of lactation1.

1

Day 1 of lactation was identified as the day when a litter was found completed (i.e. membranes, placentas cleaned up, nest build up and/or feeding of pups started)

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