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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- 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:
- Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid
- Author:
- Unknown
- Year:
- 2 005
- Bibliographic source:
- Journal of the American College of Toxicology
Materials and methods
Test guideline
- Guideline:
- other: information not available
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- hexadecanoic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Commercial grade
Test animals
- Species:
- rat
- Details on test animals or test system and environmental conditions:
- Albino rats
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- Administration of doses up to 10.0 g/Kg
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- other: information not available
- Remarks on result:
- other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid
- Mortality:
- Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no deaths
- Clinical signs:
- other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive sali
- Gross pathology:
- Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no significant gross lesions at necroscopy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Administration of doses up to 10.0 g/Kg Palmitic Acid by galvage to albino rats resulted in no deaths and no significant gross lesions at necroscopy. Transient signs of toxicity were observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive salivation and serosanguineous discharge from the muzzle and eyes.
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.
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