Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 620-582-5 | CAS number: 301341-58-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- 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:
- dipotassium 2-dodecanamidoacetate 2-tetradecanamidoacetate
- 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:
- dipotassium 2-dodecanamidoacetate 2-tetradecanamidoacetate
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
