Amines, N-coco alkyltrimethylenedi-, acetates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

not specified

GLP compliance:

not specified

Remarks:

date of studies 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

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: unspecified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 other: g/kg

Based on:

test mat.

Clinical signs:

other:

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Published data report the LD50 of an analogue substance to be > 5 g/kg following oral administration.

Executive summary:

Results from three studies involving an analogue substance are available. In the first study, an acute oral toxicity test in male and female Sprague-Dawley rats, undiluted cocamide DEA had an LD50 of 12.2 g/kg. In the second study, the acute oral toxicity of cocamide DEA was determined using groups of 3 male and 3 female Wistar rats. Three or more animals per group died with doses of ≥ 6.3 g/kg. In the third study, LD50 of cocamide DEA was reported as > 5 g/kg or 5 mL/kg, which was the highest dose tested.