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EC number: 945-893-6 | CAS number: -
The teratology of diesel fuel was examined by whole body exposure of pregnant female (CRL: COBS CD (SD) BR) rats to graded measured airborne (vapour) of 0, 101.8, or 401.5 ppm (equivalent to 0, 530, and 2110 mg/m3, respectively) on days 6 through to 15 of gestation. The pregnant female rats were approximately 11 weeks of age at the time of the first dose and were assigned sequentially to treatment groups of 20 animals each. They were exposed to diesel fuel for 6 hours/day in 0.25 m3 stainless steel and plexiglass chambers operated under negative pressure. The animals were assessed daily for body weight changes, food consumption, and clinical observations.
There were no deaths during the course of the study and all females were normal in appearance. Mean body weights indicated no significant differences between control and treated pregnant rats, although the food consumption of the high-dose group was significantly lower (p < 0.05) than the controls during treatment.
On day 20 of gestation, the study was terminated and the rats were anaesthetised with chloroform. Following anaesthesia, gross examination of the organs, examination of the uterus (number of implantation sites, live/dead foetuses, number of resorption sites) and foetal examinations (soft tissue and skeletal) were performed.
Examination at necropsy revealed two high-dose females with dark, mottled lungs. One of these animals had a rough spleen but no further description was provided for this and the authors did not consider either of these effects to be treatment related.
Diesel fuel did not appear to have any effect on the uterus and examination of the offspring revealed no visible abnormalities except for the occurrence of subcutaneous haematomas in 1/188, 4/227 and 4/188 in the control, low-, and high-dose groups, respectively. All litters appeared normal and the sex ratio did not differ significantly between treated and control groups. Some unusual skeletal variations related to retarded bone ossification were observed, including reduced ossification of the parietal bones and the frontal bones, and wavy ribs. These changes were noted in 7 and 17 pups from 3 and 8 litters of the control and low-dose animals only, and were not dose related. The authors concluded that neither the frequency nor the character of these changes indicated an adverse effect on foetal growth and development or a teratogenic potential. Other skeletal variations were considered to be common to animals of this strain.
The authors concluded that exposure of ratsto diesel fuel (vapour) did not result in compound-induced terata, variation in sex ratio, embryo toxicity or inhibition of foetal growth and development. Therefore the NOAEC was 2,110 mg/m3 (401.5 ppm), the highest concentration tested.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because the study is well-documented and generally followed OECD 414 guidelines. No information was available on GLP.
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