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DL-LACTONE CAS N°:79-50-5 - page 92 / 113

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OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Result:

The contents of the tubes were mixed and poured immediately onto Vogel-Bronner minimal agar plates. Three replicates for the test compound at each treatment and concentration and for the negative control or two replicates for the positive controls were incubated at 37°C, uspide down, for 2 days. Liquid pre-incubation assay The following solutions are added in order: 0.1 ml of test compound at different concentrations or of the solvent or 0.05 ml of the different reference substances; 0.5 ml of S9 mix or, for tubes without metabolic activation, 0.5 ml sodium-phosphate-buffered saline at 0.2M, pH7.4; 0.1 ml of overnight cultures of the bacterial strain. The test tubes are incuibated and shaken for 30 min at 37°C. 2.2 ml soft agar supplemented with 21 µg L-histidine and 24.4 µg biotin was added afterwards and the content of the tubes were mixed and poured onto Vogel-Bronner minimal agar plates. Three replicates for the test compound at each treatment and concentration and for the negative control or two replicates for the positive controls were incubated at 37°C, uspide down, for 2 days. Data reporting COlonies are usually counted electronically using a Domino automatic image analysis system (Perceptive Instruments, Haverhill, England). Microscopic examination of the bacterial background lawn, resulting from the trace of histidine added, is an aid to determine the toxicity of the test compound. Toxicity was noted if apparent. The dose compund was soluble in water. No toxic effects were seen up to the highest dose tested of 5000 µg/plate. The test compound did not induce any dose-related increase in the number of revertant colonies per plate in any of the five tester strains (full details given in two tables, one each for standard Ames procedure and for liquid pre-incubation). The mutant frequencies in the controls were in the range of the lab's historical control values and of data from literature. The positive controls induced significant increases in the mutant frequencies, verifying the sensitivity

Test substance:

Conclusion:

Reliability:

Flag: 16-NOV-2005

of the strains used. Ro 01-4479/000 (=dl-Lactone pure) from Roche Dalry, batch no. 805046, Analysis no. A9819037, assay 100% (anhydrous), expiry date 05/2002. In a bacterial reverse mutation assay assay as described with five strains of Salmonella typhimurium, at doses of 50-5000 µg/plate, with and without metabolic activation by S9 mix, with standard Ames procedure and with liquid pre-incubation,

of

mutagenic

activity.

(23)

dl-lactone did not show any indication

GLP.

(1)

valid without restriction

test

under

endpoint

International

standard

Critical

study

for

SIDS

Type:

Micronucleus assay

Species:

mouse

Strain:

other: NMRI BR

Route of admin.:

gavage

Exposure period:

24 and 48 hours

92

UNEP PUBLICATIONS

5.6 Genetic Toxicity 'in Vivo'

Sex: male/female

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