Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Undiluted Cocamide DEA was tested on SD rats and found to have an LD50 of 12.2 g/kg and a 95% confidence limit of 10.7-14.4 ml/kg.

(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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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.
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
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.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
12.2 other: g/kg
Based on:
test mat.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
12 200 mg/kg bw

Additional information

Justification for classification or non-classification