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EC number: 270-681-9 | CAS number: 68476-40-4
The study assessed the potential toxicity, including neurotoxicity and reproductive performance in male and female rats following ethane exposure at 1600, 5000 and 16000 ppm (highest exposure level was 50% of the lower explosive limit). It also was designed to investigate effects in both sexes on mating behaviour and on gonadal function, as well as effects on conception, development, parturition and pup survival to lactation day 4. Male and female rats were exposed for 6 hours/day, 7 days/week for 2 weeks prior to mating initiation. Main study females were evaluated for subchronic effects and were exposed once daily (6 hours/day), seven days/week for 4 weeks (28 days). A satellite group of females was evaluated for reproductive effects only - exposed once daily (6 hours/day), seven days/week for at least two weeks prior to mating initiation, then once daily during mating and gestation (days 0-19). For satellite female rats without evidence of mating that appeared to be pregnant, exposure was terminated on the estimated gestation day 19. Main study male rats were exposed during the mating and post-mating periods until euthanized for a minimum exposure of 28 days.
There was no effect on survival. There were no exposure-related clinical effects or effects on body weight, food consumption, FOB or motor activity parameters for either sex (except the16000 ppm exposed animals showed marginally lower food consumption during the first week of exposures). There were no exposure-related differences in haematology, clinical chemistry and no macroscopic or microscopic changes at post-mortem.
Almost all mated female animals were found pregnant and delivered live pups. Mating indices for the ethane male rats were comparable to control. Mating, fertility and gestation indices for the female rats were comparable to control. All but one of the females in each group mated at the first opportunity. There were also no treatment-related differences in the other reproductive parameters up to the time of parturition including the percent off males completing delivery and the duration of gestation. There were no exposure-related differences in any parturition parameters including pre-implantation loss, post-implantation loss, the total number of pups delivered, the number of pups dying, the viability (4 day survival) index, the pup sex ratio and the number of live pups/litter, when compared to the air control group. There were no exposure-related differences in body weights or weight gains in the pups feeding from ethane exposed females during gestation compared to the pups feeding from air control animals. There were no macroscopic changes at post-mortem.
Exposure of male and female rats to target concentrations of 1600, 5000 or 16000 ppm of ethane by whole-body inhalation for 4-6 weeks resulted in no general systemic/neurotoxic effects apart from a very marginal reduction of food consumption during the first week of exposure at 16000 ppm and this transient difference was considered not to be adverse. There were no effects on fertility or reproductive performance, including offspring survival and weight development up to post-natal day 4.
A no-observed-adverse effect concentration (NOAEC) of 16000 ppm was determined for all endpoints. Equivalent to 19678 mg/m3 (MW 30.07g/mol).
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