Amines, N-coco alkyltrimethylenedi-, acetates

Toxicity to reproduction

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Diethanolamides as Used in Cosmetics; Amended Final Safety Assessment

Author:

Cosmetic Ingredient Safety Review (CIR) panel

Year:

2011

Bibliographic source:

1101 17th Street, NW, Suite 412, Washington DC 20036-4702, United States of America

Report date:

2011

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Amides, coco, N,N-bis(hydroxyethyl)

EC Number:

271-657-0

EC Name:

Amides, coco, N,N-bis(hydroxyethyl)

Cas Number:

68603-42-9

Molecular formula:

C16H33NO

IUPAC Name:

N,N-Bis(2-hydroxyethyl)dodecanamide

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

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

Target system / organ toxicity (P0)

Critical effects observed:

no

Results: F1 generation

Effect levels (F1)

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

Target system / organ toxicity (F1)

Critical effects observed:

no

Overall reproductive toxicity

Reproductive effects observed:

no

Applicant's summary and conclusion

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.