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Chronic toxicity, oncogenicity, and mutagenicity studies with chlorotetrafluoroethane (HCFC-124)
L A Malley1, S R Frame, G S Elliott
1E.I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine, Newark, Delaware 19714, USA.
Drug and Chemical Toxicology
|December 5, 1998
Summary
Chlorotetrafluoroethane (HCFC-124) showed no toxicity or carcinogenicity in rats during a two-year inhalation study. The no-observed-adverse-effect level was 50,000 ppm, and HCFC-124 was not mutagenic in bacterial or human cell assays.
Area of Science:
- Toxicology
- Environmental Chemistry
Background:
- Chlorotetrafluoroethane (HCFC-124) is an industrial chemical requiring safety evaluation.
- Assessing chronic toxicity, oncogenicity, and mutagenicity is crucial for understanding HCFC-124's environmental and health impact.
Purpose of the Study:
- To evaluate the chronic toxicity, oncogenicity, and mutagenicity of chlorotetrafluoroethane (HCFC-124).
- To determine the no-observed-adverse-effect level (NOAEL) for HCFC-124 in a long-term inhalation study.
Main Methods:
- Rats were exposed to HCFC-124 (0–50,000 ppm) for 6 hr/day, 5 days/week, over 2 years.
- Comprehensive monitoring included body weight, food consumption, clinical signs, ophthalmology, clinical pathology, and histopathology.
- Mutagenicity was assessed using Salmonella typhimurium strains, cultured human lymphocytes, and mouse bone marrow micronucleus tests.
Main Results:
- No adverse effects on body weight, food consumption, survival, or clinical pathology were observed in rats at any exposure level.
- Increased urine and plasma fluoride levels were noted but considered non-adverse metabolic byproducts.
- HCFC-124 demonstrated no toxicity or carcinogenicity in rats and was not mutagenic or clastogenic in in vitro and in vivo assays.
Conclusions:
- HCFC-124 is not toxic or carcinogenic in rats following chronic inhalation exposure up to 50,000 ppm.
- The no-observed-adverse-effect level for HCFC-124 in rats was determined to be 50,000 ppm.
- HCFC-124 does not pose a mutagenic risk based on the conducted assays.
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