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Safety assessment of lactate esters
J J Clary1, V J Feron, J A van Velthuijsen
1Bio Risk, Midland, Michigan, 48641, USA.
Regulatory Toxicology and Pharmacology : RTP
|July 22, 1998
Summary
Lactate esters show low acute toxicity and are not skin sensitizers. Recommended occupational exposure limits for vapors are 75 mg/m3, but aerosol exposure should be minimized to prevent nasal irritation.
Area of Science:
- Toxicology
- Occupational Health
- Environmental Science
Background:
- Lactate esters are widely used chemicals with potential for occupational exposure.
- Understanding their toxicological profile is crucial for setting safe handling guidelines.
Purpose of the Study:
- To evaluate the toxicity of various lactate esters via inhalation and dermal routes.
- To determine safe occupational exposure limits for lactate esters.
- To assess the environmental impact of lactate esters.
Main Methods:
- Acute oral and inhalation toxicity studies (LD50, LC50).
- Dermal and inhalation subacute toxicity studies, including teratogenicity and maternal toxicity assessments.
- Sensory irritation tests to establish human exposure limits.
- Biodegradability assessments.
Main Results:
- Lactate esters exhibit low acute toxicity (oral LD50 > 2000 mg/kg, inhalation LC50 > 5000 mg/m3).
- No teratogenic or maternal toxicity observed. Nasal cavity changes noted in subacute inhalation studies.
- NOAEL for vapors was 200 mg/m3 for ethyl, n-butyl, and isobutyl-l-lactate. Minimal nasal damage at 75 mg/m3 for 2-ethylhexyl-l-lactate aerosol.
- Recommended occupational exposure limit for vapor is 75 mg/m3; aerosol exposure should be minimized.
Conclusions:
- Lactate esters are generally safe with low systemic toxicity, primarily causing irritation at high concentrations.
- An occupational exposure limit of 75 mg/m3 for vapor is recommended to prevent irritation.
- Readily biodegradable nature suggests minimal environmental concern.