Registration Dossier

Diss Factsheets

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:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Actual version not specified in the review document
Deviations:
not specified
GLP compliance:
not specified
Remarks:
data taken from a CIR review paper. Full details are not disclosed and the test was 1983 so GLP not necessarily required at that time.
Test type:
other: 100% Cocamide DEA in varying amounts was administered to five rats in a single dose by gavage

Test material

Constituent 1
Chemical structure
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
Specific details on test material used for the study:
Cocamide DEA (Amides, coco, N,N-bis(hydroxyethyl) is the ethanol derivative rather than the propionate equivalent, which is the substance under review.
It is essentially the same structural formula with an ethyl group instead of a propyl group and as such is assessed as being a good surrogate substance for read-across in the absence of actual oral toxicity data on the substance itself. It is not thought necessary to advise that further animal testing should be carried out.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Various
No. of animals per sex per dose:
5
Details on study design:
Cocamide DEA in varying amounts was administered to five rats in a single dose by gavage following a 16-h fast, then the rats were observed for 14 days.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
12.2 other: g/kg
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Undiluted Cocamide DEA was slightly toxic, with an LD50 of 12.2 g/kg and a 95% confidence limit of 10.7-14.4 ml/kg.
Limit tests on formulations containing either 10 or 12% Cocamide DEA were unremarkable.