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DL-LACTONE CAS N°:79-50-5 - page 10 / 113

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2.3

Human Exposure

2.3.1

Occupational Exposure

Occupational exposure to DL-lactone is expected to be low, as the substance is used as an intermediate in a closed process. Exposure mainly occurs through completion of process sampling and potentially during drumming-off operations (COSHH assessment).

2.3.2

Consumer Exposure

In view of the use of the substance consumer exposure is not anticipated.

3

HUMAN HEALTH HAZARDS

3.1

Effects on Human Health

OECD SIDS

DL-LACTONE

3.1.1

Toxicokinetics, Metabolism and Distribution

No data available.

3.1.2

Acute Toxicity

The acute toxicity of DL-lactone was investigated in rats and mice.

Studies in Animals

The oral LD50 in rats and mice was 9700 and 4380 mg/kg bw, respectively. No information on clinical symptoms, body weight or macroscopy was available from these studies. Animals were observed for a total of 10 days (Bächtold, 1976).

In the range finding test for a micronucleus test in mice (Meerts, 2002) 2000 mg/kg bw dosed orally caused 4 of 8 animals to die within 1.5 hours. At 1500 mg/kg bw no mortality was found. No LD50 can be drawn from this study. Clinical signs were reported for all animals treated with 2000 mg/kg bw. Within 1.5 hours, all animals showed lethargy or convulsions, one animal had tremors. Lethargy and rough coat was also observed within 1.5 hours after treatment with 1500 mg/kg bw. At both doses the survivors showed no abnormalities anymore after 2 and 3 days.

Studies in Humans No data available. Conclusion The LD50 of DL-lactone via the oral route is > 2000 mg/kg bw.

3.1.3 Irritation Skin Irritation Studies in Animals

DL-lactone was not irritating to the skin of rabbits after 4 hours exposure under semi-occlusion (according to OECD 404). No symptoms of systemic toxicity were observed during the 72-hours treatment period (Teunissen, 2005a).

10

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