Registration Dossier
Registration Dossier
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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment)
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Principles of method if other than guideline:
- A study was conducted to evaluate if palm oil have any clastogenic effects in Balb/c mice. 10 mice were used per group, one treated with palm oil, one with red palm oil and one control group treated with corn oil. The exposure period lasted 5 d and the dose was 4500 mg/kg bw. Analyses were made on bone marrow metaphase cells isolated 24 h p.a. for chromosome abberations and mitotic index.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- Cas Number:
- 67701-30-8
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Palm oil, refined and red palm oil, crude (CAS N° 8002-75-3, EC N° 232-316-1); under the SDA nomenclature the name of this substance is 'Glycerides, C16-18 and C18-unsatd.'
- Substance type: Triglycerides of vegetable origin
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- No data
- Details on exposure:
- No data
- Duration of treatment / exposure:
- 5 d
- Frequency of treatment:
- No data
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4500 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 10 female mice per group
- Control animals:
- yes
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Bone marow cells
- Details of tissue and slide preparation:
- No data
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No statistically significant difference in the frequency of chromosomal aberrations and mitotic index between either the treated groups and the control group
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of the test, the test substance did not show any clastogenic effects in mice bone marrow cells. - Executive summary:
A study was conducted to evaluate if ‘glycerides, C16-18 and C18-unsatd.’ (as palm oil) have any clastogenic effects in Balb/c mice.
10 mice were used per group, one treated with the test substance, one with red palm oil and one control group treated with corn oil. The exposure period lasted 5 d and the dose was 4500 mg/kg bw. Analyses were made on bone marrow metaphase cells isolated 24 h p.a. for chromosome abberations and mitotic index.
The study showed no statistically significant difference in the frequency of chromosomal abberations and mitotic index between either of the treated groups and the control group.
Under the conditions of the test, the test substance did not show any clastogenic effects in mice bone marrow cells.
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