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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Amides, coco, N,N-bis (hydroxyethyl) (CASRN 68603-42-9)

Groups of gravid female Sprague-Dawley rats (number per group not specified) were gavaged with 5 ml/kg bw of 0, 100, 300, or 1000 mg/kg/day cocamide DEA, 90-95% pure, on days 6-15 of gestation.25Controls were dosed with arachis oil. The dams were killed on day 20 of gestation. No deaths occurred in any of the groups. Salivation and propulsion of the head was observed in all test groups; salivation was “severe” in the 1000 mg/kg group. Body weights and weight gains were comparable for all groups, as were fetal body weights. Post-implantation loss and total embryonic deaths were statistically significantly increased in all treated groups compared to the controls; these findings were considered incidental by the researcher because one single female accounted for these findings in each group. Retardation of ossification was statistically significantly increased in the 300 and 1000 mg/kg groups; again, the researcher found this effect to be incidental because the values were within the normal range of variation for this strain. The incidence of ossification of the skull bones was statistically significantly increased in the 1000 mg/kg group; two dams accounted for 10 of the 17 findings in this group.

The NOAELs for maternal toxicity and developmental toxicity were both reported as 1000 mg/kg/day.

Since diethanolamine may bepresent as an impurity in the diethanolamides data are presented also for CAS n. 111 -42 -2

Diethanolamine CAS N° 111 -42 -1

Diethanolamine was administered by gavage to Sprague-Dawley rats on days

6–15 of gestation at dose levels of 0, 50, 200, 500, 800 or 1200 mg/kg bw per day. The

rats were killed on day 20 and the uteri examined for number of implantation sites and

for live and dead implantations. Rats receiving 500 mg/kg bw or higher doses either

died or were in a moribund condition and were killed. Maternal body weight gain was

reduced in the 200-mg/kg bw group, but none of the gestational parameters in the

treated groups was significantly different from those of the controls.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal 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
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Data conclusive but not sufficient for classification

Additional information