Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from similar mixture/product
- Adequacy of study:
- key study
- Study period:
- 2015
- 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:
- Safety Assessment of Ethanolamides as Used in Cosmetics
- Year:
- 2 015
- Bibliographic source:
- International Journal of Toxicology 2015, Vol. 34(Supplement 1) 18S-34S - CIR database
Materials and methods
- Principles of method if other than guideline:
- Data are extracted from the 2015 review of the International Journal of Toxicology about the assessment of ethanolamides. Since the studies reported are dated back to 1993 (Andersen FA (ed). Final report on the safety assessment of acet- amide MEA. J Am Coll Toxicol. 1993;12(3):225-236), 2000 (European Commission—European Chemicals Bureau. IUCLID Dataset. N-(2-hydroxyethyl)dodecanamide; 2000. Web site. http://esis.jrc.ec.europa.eu/doc/existing-chemicals/IUCLID/data_ sheets/142789.pdf and European Commission—European Chemicals Bureau. IUCLID dataset. Amides, coco, N-(Hydroxyethyl); 2000. Web site. http://esis.jrc.ec.europa.eu/doc/existing-chemicals/IUCLID/data_ sheets/68140001.pdf. Accessed August 4, 2011), 2004 (Environmental Protection Agency. Appendix 1. Robust summa- ries. ACC FND Amides Category I—FND Amides; 2004. Web site. http://www.epa.gov/hpv/pubs/summaries/fantdrad/c133 19rr.pdf. Summaries of unpublished data) and 2010 (Environmental Protection Agency. Screening-level hazard char- acterization, fatty nitrogen derived (FND) amides category; 2010. Web site. http://www.epa.gov/chemrtk/hpvis/hazchar/Category_ FND%20Amides_September_2010.pdf. Summaries of unpub- lished data) we assume that it was performed according to OECD 401
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethanolamides
- IUPAC Name:
- Ethanolamides
- Test material form:
- solid: granular
Constituent 1
Test animals
- Species:
- rat
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- from 1 to 32 g/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Remarks on result:
- other: Cocamide MEA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Remarks on result:
- other: Cocamide MEA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 7 400 mg/kg bw
- Remarks on result:
- other: Cocamide MEA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 27 000 mg/kg bw
- Remarks on result:
- other: Acetamide MEA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Lauramide MEA
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not toxic for ingestion according to criteria set out in Regulation (EC) n. 1272/2008 (CLP)
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