isostearic acid monoisopropanolamide

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

A study was carried out to assess the effects of the read-across substance amides, C12-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) on the embryonic and foetal development in pregnant Sprague-Dawley CD rats according to OECD Guideline 414. The substance was administered to groups of 30 female rats by gavage at dose levels of 0, 100, 300 and 1000 mg/kg bw/day, once daily from Gestation Days (GD) 6 to 15 of gestation inclusive. Control animals were dosed with the vehicle alone (arachis oil, DAB 9). Clinical condition and reaction to treatment were recorded at least once daily. Body weights were reported on GD 0, 6, 16 and 20. All surviving females were sacrificed on GD 20 and the foetuses were removed by caesarean section. At necropsy, the females were examined macroscopically. Live foetuses were weighed, sexed and examined for visceral and skeletal abnormalities. No deaths or treatment-related changes in body weight gain and necropsy findings were observed in dams at any dose level. Treatment-related symptoms observed in all groups were salivation and propulsion of the head. The highest dose group showed severe salivation. Apart from the control (1 dead foetus) and the 100 mg/kg bw/day groups (7 dead foetuses), all females had viable foetuses. Pre-implantation loss and mean numbers of resorptions were not affected by treatment. The data for post-implantation loss, embryonic deaths and total foetuses showed some deviations, which were considered to be non-treatment-related. Mean placental and uterus weights were not affected by the treatment. Foetal sex ratio was comparable in all groups. No treatment-related foetal abnormalities were found at necropsy. The examined foetuses showed no treatment-related visceral and skeletal abnormalities/variations. One foetus at 300 mg/kg bw/day showed a stump tail and missing coccigycae vertebrae. Further, the data for skeletal ossifications showed some deviations in the two highest dose groups. However, all these effects were assessed to be non-treatment-related. Under the study conditions, the NOAELs for parental toxicity and developmental toxicity were considered to be 1000 mg/kg bw/day (Pitterman, 1994).