Amines, N-coco alkyltrimethylenedi-, acetates

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

The NOAEL for maternal toxicity toxicity was reported as the highest dose level of 1000 mg/kg/day in a study involving an analogue substance (EC 271-657-0].

Link to relevant study records

Reference

Reference 1

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

not specified

GLP compliance:

not specified

Remarks:

date of study not specified

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

other: no adverse effects reported at the highest dose level of 1000 mg/kg bw/day

Critical effects observed:

no

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Remarks:

maternal dose

Sex:

male/female

Remarks on result:

other: no adverse effects reported at the highest maternal dose of 1000 mg/kg bw/day

Critical effects observed:

no

Reproductive effects observed:

no

Conclusions:

NOAEL values for maternal toxicity and developmental toxicity were both reported as 1000 mg/kg/day.

Executive summary:

Groups of gravid female Sprague-Dawley rats (number per group not specified) received 5 mL/kg bw of 0, 100, 300, or 1000 mg/kg/day cocamide DEA, 90-95% pure, by gavage, on days 6-15 of gestation. Controls 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. NOAEL values for maternal toxicity and developmental toxicity were both reported as 1000 mg/kg/day.

Reference 2

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

See read-across justification attached in Section 13.

Reason / purpose for cross-reference:

read-across source

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

other: no adverse effects reported at the highest dose level of 1000 mg/kg bw/day

Critical effects observed:

no

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Remarks:

maternal dose

Sex:

male/female

Remarks on result:

other: no adverse effects reported at the highest maternal dose level of 1000 mg/kg bw/day

Critical effects observed:

no

Reproductive effects observed:

no

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Groups of gravid female Sprague-Dawley rats (number per group not specified) received 5 mL/kg bw of 0, 100, 300, or 1000 mg/kg/day cocamide DEA, 90-95% pure, by gavage, on days 6-15 of gestation. Controls 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. NOAEL values for maternal toxicity and developmental toxicity were both reported as 1000 mg/kg/day.

Effects on developmental toxicity

Description of key information

The NOAEL for developmental toxicity was reported as the highest maternal dose level of 1000 mg/kg/day in a study involving an analogue substance (EC 271-657-0].

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Additional information

Groups of gravid female Sprague-Dawley rats (number per group not specified) received 5 mL/kg bw of 0, 100, 300, or 1000 mg/kg/day cocamide DEA, 90-95% pure, by gavage, on days 6-15 of gestation. Controls 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. NOAEL values for maternal toxicity and developmental toxicity were both reported as 1000 mg/kg/day.

Justification for classification or non-classification

NOAELs for maternal toxicity and developmental toxicity were both reported as the highest dose level of 1000 mg/kg/day in a study involving an analogue substance (EC 271-657-0]. Classification for reproductive or developmental toxicity is therefore not required under the criteria given byRegulation (EC) No. 1272/2008.