Registration Dossier
Registration Dossier
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EC number: 947-548-5 | CAS number: -
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:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
- 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
- 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
Constituent 1
- 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.
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