Registration Dossier
Registration Dossier
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EC number: 310-083-8 | CAS number: 102242-52-4 The complex residue resulting from the distillation of C6-24 and C6-24 unsatd. fatty acids methyl esters which is derived from natural fats having a carbon range of C6-24. It consists predominantly of satd. and unsatd. fatty acids methyl esters having carbon numbers greater than C20, dimerization products, and wax esters and boils at > 200°C (392°F) at 10 torr.
Endpoint summary
Administrative data
Description of key information
LD 50 = greater than 2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 2, 1988 to February 29, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described study conducted to recognized international test guidelines. No data about testing material
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- single dose of 10 ml/kg corresponding to 2000 mg/Kg bw per substance
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Non toxic
- Executive summary:
The acute oral toxicity of Edenor ME Ruckstand II was tested in young Wistar rats, breeder Winkelmann Borchen. The test compound was administered by single gavage in arachids oil as solvent and an application volume of 10 ml/Kg body weight to fasted animals. Five rats were used per sex.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The median lethal dermal dosage (LD50) for Fatty acids, C6-24 and C6-24 unsaturated, methyl esters, distillation residues in Sprague-Dawley rats was estimated to be greater than 2000 mg/kg.
Justification for classification or non-classification
Classification is only relevant for LD50 < 2000 mg/kg from any route of exposure and none of the tests have indicated such a result.
No classification for acute toxicity is warranted under 67/548/EEC or Regulation 1272/2008.
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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