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EC number: 947-817-7 | CAS number: -
Maternal toxic Effects
25, 50, 100, 200, and 400 mg test material /kg bw/day using 3 animals per dose group.
Dose of test substance (mg/kg bw/day)
2/3 (day 18,26)
3/3 (all day 10)
3/3 (all day 7)
At 50 and 100 mg groups, a clear fall in body weight was observed between days 12 and 18. At 25 mg, two of the three females showed anorexia. From first day of treatment food consumption was clearly decreased at 50 and 100 mg/kg.
No mortality, no difference of growth curve of treated groups compared to controls, no difference in food consumption. There was a higher number of non-pregnant females in group I. The rate of resorptions is considered low, and comparable in all groups. No histopathology was performed on the sacrificed dams end of term.
Preliminary study on 25, 50, 100, 200, and 400 mg test material/kg bw/day using 3 animals per dose group. At 50 mg, the two females showed resorption sites. The weight of foetuses of the 50 mg group were low. Macroscopic examination, number and mean weight of foetuses of the 25 mg group showed no embryotoxic effect. 50 mg/kg/day seems to be the threshold for an indirect embryotoxic action.
No foetal mortality was observed. External abnormalities In the high dose group, one foetus showed a torsion of the fore limbs. No other external abnormality was observed in any of the dose groups. Visceral abnormalities
- Dilated and haemorrhagic cerebral ventricles in one foetus of control group
- left hydro-ureter in one foetus of low dose group.
- Retinal folds in region of optic nerve in 13 foetuses: Control: 3 (11%); low dose: 2 (9%); mid dose: 4 (14%); and high dose: 4 (16%). These were considered to be caused by fixation artefact. Skeletal abnormalities: Incidence in treated groups are comparable to controls.
Table for Maternal effects (separate data for all dosage groups)
dose-response+ / -
Number of dams examined
Clinical findings during application of test substance
Mortality of dams
Body weight (day 28) g
gain day 0-28 (end of test) g,gain day 6-18 (treatment) g,
Food consumption (g/day/dam)day 0-5day 6-18 (treatment)day 19-29
if test substance is applied with drinking water
pregnancy rate or %
Necropsy findings in dams dead before end of test
Table for developmental effects (separate data for all dosage groups)
Litter response (Caesarean section data)
Number full-term pregnant females
number per pregnant female
total number of foetusesnumber per pregnant female
total number of litters
fetuses / litter
live fetuses / litter
dead fetuses / litter
fetus weight (mean)
placenta weight (mean)
crown-rump length (mean)
Fetal sex ratio
[state ratio m/f]
Table for developmental effects (separate data for all dosage groups)
Examination of the foetuses
Skeletal abnormal ossifications12thpair complete [%]13ribs left side [%]13ribs right side [%]13thpair complete [%]
incomplete ossifications sternebrae
incomplete ossifications skull
missing ossifications sternebrae
A study was conducted to determine the teratogenicity of read across substance, C12-14 TMAC (active: 35%), according to the method comparable to OECD 414. During gestation Days 6 -18, four groups of 13 female New Zealand White rabbits were dosed by stomach tube at dose levels of 0, 2, 8 and 24 mg/kg bw/day of test substance (35% C12-14 TMAC in dobanol 45E7 (i.e., C14 -15 AE7)), in 2 mL/kg bw/day daily prepared solutions in water. Animals were sacrificed on Day 29. Examinations included daily observations of behaviour and clinical symptoms, daily food consumption, and body weight every three days. Upon sacrifice, number of corpora lutea, implantations and resorptions were examined. For foetuses, number of viable and dead, macroscopic external examinations, sex, individual weights, skeletal examinations (2/3), and visceral abnormalities (1/3) were conducted. A preliminary study was undertaken under similar conditions, applying 5 dose groups: 0, 25, 50, 100, 200 and 400 mg/kg bw/day using three animals per dose group. At 50 mg, the two females showed resorption sites. The weight of foetuses of the 50 mg group were low. Macroscopic examination, number and mean weight of foetuses of the 25 mg group showed no embryotoxic effect. 50 mg/kg/day did seem to be the threshold for an indirect embryotoxic action. In the final study, no signs of maternal toxicity was observed. Also no foetal mortality was observed. Numbers of corpora lutea and resorptions were comparable. The number of pregnancies at the low dose group did seem to be diminished, but this was considered an incidental observation. There was no change in frequency of external, visceral and skeletal observations. No maternal toxic or embryotoxic/teratogenic effects were seen up to hightest tested dose of 24 mg/kg bw/day (i.e., equivalent to 8.4 mg a.i./kg bw/day). Under the conditions of the study, the NOAEL of read across substance for maternal and embryotoxic effects/teratogenicty was at 24 mg/kg bw/day (i.e., equivalent to 8.4 mg a.i./kg bw/day) (Fave 1980). Based on the results of the read across study, similar NOAELs for maternal and development toxicity is considered for the test substance, Oleyl TMAC.
A study was conducted to determine the developmental toxicity / teratogenicity of the read across substance, C16 TMAC (active: 25%), according to a method similar to OECD Guideline 414, in compliance with GLP. This experiment was performed in New Zealand White rabbits. Twenty mated female rabbits per group were exposed topically (daily for 2 hours) from Days 7 to 18 of gestation at concentrations of 0, 0.5, 1.0, or 2.0% (equivalent to 0, 10, 20 and 40 mg a.i./kg bw/day, respectively). The control group was treated with deionised water only. Clinical condition and reactions to treatment were recorded at least once daily. Body weights were recorded on Days 0, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 29 of gestation. All surviving females were sacrificed on Day 29 of gestation and the foetuses were removed by caesarean section. At necropsy the females were examined macroscopically. Live foetuses were weighed, sexed and were examined for visceral and skeletal abnormalities. Two control animals, one intermediate and one high dose died during the study. Two of the rabbits that died, aborted prior to death (one control and one intermediate dose). Two additional abortions occurred, one each in the intermediate and high dose groups. Deaths or abortions were not considered to be related to the test substance. No treatment-related maternal body weight or food intake effects were noted. The incidence of foetal malformations, as well as genetic and developmental variations in the treated groups was comparable to that of the control group. No other treatment-related effects were noted.Under the conditions of the study, the NOAEL of the test substance for maternal as well as developmental toxicity was established at 40 mg/kg bw/day in rabbits (Albridge, 1985). Based on the results of the read across study, similar NOAELs for maternal and development toxicity is considered for the test substance, Oleyl TMAC.
A study was conducted to determine the developmental toxicity of the read across substance, C18 TMAC (active: 98.8%), according to a method similar to OECD Guideline 414. Pregnants rats were exposed dermally to the test substance from Day 6 to Day 15 of gestation. Volumes of 0.5 mL were applied on shaved skin. The concentrations of the test substance ranged from 0.0 to 2.5% (i.e., corresponding to 0, 18, 30 and 50 mg/kg bw/day). Signs of systemic reaction and local reaction of the exposed area of skin were assessed on a daily basis. Body weights were recorded on Days 1, 3, 6, 10, 17, and 20 of pregnancy. Food and water consumption were measured at regular intervals throughout the study. On Day 20 of pregnancy, congenital abnormalities and macroscopic pathological changes in maternal organs as well as in ovaries and uteri (number of corpora lutea, number/distribution of live young and embryo/foetal deaths (early and late, stages of implantation)) and post implantation loss were evaluated. Litter weights (from which the mean pup weight was calculated), foetal abnormalities (external and internal), and sex determination were also recorded on Gestation Day 20. Under the study conditions, a dermal application of the test substance did not induce toxic effects on dams or foetuses, except for a local irritation (erythema and oedema) on the skin of pregnant animals. The maternal NOAELs (systemic and local) were therefore established at 50 and 18 mg/kg bw/day, respectively. The developmental NOAEL was determined at 50 mg/kg bw/day (Palmer, 1983). Based on the results of the read across study, similar NOAELs for maternal and development toxicity is considered for the test substance, Oleyl TMAC.
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