Registration Dossier
Registration Dossier
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EC number: 942-063-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, coco derivs., reaction products with glycine, potassium salts
- EC Number:
- 620-582-5
- Cas Number:
- 301341-58-2
- Molecular formula:
- R-CO-NH-CH2-COOK (Note: "R-CO-" is a fatty acid residue)
- IUPAC Name:
- Fatty acids, coco derivs., reaction products with glycine, potassium salts
Constituent 1
- Specific details on test material used for the study:
- Lot/batch No.: 110825
Expiration date: August 25, 2014
Purity: 100%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals: Crl:WI (Charles River, Germany)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 * 3 rats
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no
- Clinical signs:
- 0.5 - 4 hrs after dosing piloerection was noted in all 6 rats. In addition, all 6 rats showed a hunched posture 2 hrs after dosing. 6 hrs after dosing and from days 1-14 all rats were free of any abnormalities.
- Body weight:
- No adverse effects observed
- Gross pathology:
- No adverse effects observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The oral LD50 is > 2000 mg/kg bw
- Executive summary:
The acute oral toxicity of the test item was examined in female Wistar rats in a study according to OECD Guideline 423 with GLP compliance. Apart from piloerection and hunched posture seen 0.5 - 4 hrs after dosing no other adverse effects were reported. The oral LD50 was > 2000 mg/kg bw.
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