Registration Dossier
Registration Dossier
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EC number: 268-084-3 | CAS number: 68002-71-1 This substance is identified by SDA Substance Name: C16-C18 trialkyl glyceride and SDA Reporting Number: 19-001-00.
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Refer to the section 13 for details on the read across justification.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single dose of fully hydrogenated coconut oil was applied dermally to guinea pigs and animals were observed for 7 days.
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd.
- EC Number:
- 266-946-3
- EC Name:
- Glycerides, C8-18 and C18-unsatd.
- Cas Number:
- 67701-28-4
- Molecular formula:
- Triglycerides containing a glycerol backbone esterified to fatty acids with a carbon chain length of C8-18 as well as unsaturated C18 fatty acids
- IUPAC Name:
- Tri(C8-18 and C18-unsatd. fatty acyl)glycerol
- Details on test material:
- - Name of test material (as cited in study report): Fully hydrogenated coconut oil (CAS N° 84836-98-6, EC N° 284-283-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18, C18 unsaturated’
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No data
- Duration of exposure:
- Single dermal application
- Doses:
- 3,000 mg/kg bw
- No. of animals per sex per dose:
- 12
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality during 7 d observation period
- Clinical signs:
- other: No data
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under test conditions, the acute dermal LD0 of the test substance in guinea pigs was found to be 3,000 mg/kg.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the constituent glycerides, C8 -18 and C18 -unsatd. (in the form of fully hydrogenated coconut oil) in guinea pigs.
The test substance was applied at a dose of 3,000 mg/kg to the skin of 12 guinea pigs. No mortality occurred during the 7 d observation period.
Under test conditions, the LD0 of the substance in guinea pigs was found to be 3,000 mg/kg (CIR, 1986).
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