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EC number: 701-175-2 | CAS number: -
One hundred twenty-five presumed pregnant Crl:CD (SD)IGS BR VAF/Plus rats were randomly assigned to five dosage groups (Groups 1 through V), 25 rats per group. Solutions of the test substance in Neutral Oil 100 N, or the vehicle, Neutral Oil 100 N, were administered percutaneously once daily to rats in Groups II through V on days 6 through 20 of presumed gestation (DGs 6 through 20) at dosages of 0 (vehicle), 5, 15 and 45 mg/kg/day. The dosage volume was 2.0 mL/kg, adjusted daily on the basis of the individual body weights recorded immediately before application of the test substance. Rats assigned to Group I were not administered the test substance or vehicle; sham dosing procedures were completed each day with an empty syringe.
Viabilities, clinical observations, skin reaction grading, body weights and feed consumption values were recorded. All surviving rats were sacrificed on DG 21 and Caesarean-sectioned, and a gross necropsy of the thoracic, abdominal and pelvic viscera was performed. Uteri of apparently nonpregnant dams were examined to confirm the absence of implantation sites. Tissue with gross lesions were retained.
The fetuses were weighed and examined for gross external alterations and sex. Approximately on-half of the fetuses in each litter were examined fresh for soft tissue alterations; the remaining fetuses (approximately one-half of the fetuses in each litter) were examined for skeletal alterations after staining.
The number of rats (eight) sacrificed for humane reasons due to adverse clinical observations (excessive vocalization, hyperactivity and gasping) occurring immediately following test substance application in the 45 mg/kg/day dosage group was significantly increased as compared to the sham control and vehicle control groups. These signs were also observed in rats that were not sacrificced; however, the extent of and the duration of the vocaliztion and hyperactivity did not justify sacrifice. All other rats survived until scheduled sacrifice.
Test substance related increases or significant increases in the number of rats with hyperactivity, vocalization, gasping and brown discoloration of the skin occurred in the 15 and 45 mg/kg/day dosage groups. Test substance related significant increases in the number of rats with grade 1 flaking, grade 1 edema and erythema, grade 2 flaking and scabs at the administration site occurred in the 15 and 45 mg/kg/day dosage groups and grade 2 erythema and edema and grade 3 flaking occurred in the 45 mg/kg/day dosage group. An ulceration at the administration site was observed in the 45 mg/kg/day dosage group. No maternal gross lesions occurred at necropsy.
Body weight gains were significantly reduced in the 15 and 45 mg/kg/day dosage groups, as compared to the sham control group and/or vehicle control group values for the entire dosage period (calculated as DGs 6 to 21), for the entire gestation period (dgs 0 to 21) and at numerous tabulated intervals during the dosage period. Test substance related significant reductions in maternal body weights occurred on DGs 10 to 21 in the 45 mg/kg/day dosage group.
Gravid uterine weights were comparable among the test material treated groups as well as the control groups. Corrected maternal body weight gains for DGs 6 to 21C and 0 to 21C (21C = DG 21 body weight minus the gravid uterine weight) were significantly reduced, as compared to the sham control group and/or vehicle control group values, in the 15 and 45 mg/kg/day dosage groups.
Absolute (g/day) feed consumption values were significantly reduced in the 45 mg/kg/day dosage group, as compared to the sham control group and the vehicle control group for the entire dosage period (calculated as DGs 6 to 21). These values were also significantly reduced, as compared to the sham control group and/or the vehicle control group at each tabulated interval during the dosage period.
No Caesarean-sectioning or litter parameters were affected by dosages of the vehicle or test substance as high as 45 mg/kg/day.
No fetal gross external, soft tissue or skeletal alterations (malformations or variations) were caused by dosages of the test substance as high as 45 mg/kg/day. All alterations were considered unrelated to the test substance because: 1)they were not dosage dependent; 2)the litter incidence was not significantly different from either control group value; and/or 3) they were within the ranges observed historically at the Testing Facility.
On the basis of these data, the maternal no observed adverse effect level (NOAEL) is 5 mg/kg/day. Adverse clinical observations, skin reactions and reductions in body weights and feed consumption were observed in the 15 and/or 45 mg/kg/day dosage groups. An increase in the number of rats sacrificed for humane reasons was observed in the 45 mg/kg/day dosage group. No developmental effects were see at any dose that were related to the treatment with Amines, C12-C14 tert-alkyl. The developmental NOEL is 45 mg/kg/day.
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