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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / 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:
documentation insufficient for assessment

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

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:
mammalian bone marrow chromosome aberration test

Test material

Constituent 1
Chemical structure
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
Molecular formula:
Triglycerides containing a glycerol backbone esterified to fatty acids of chain length varying from C16 to C18, including unsaturated C18
IUPAC Name:
Mono-di- and tri-(C16-18 and C18-unsatd. fatty acyl)glycerol
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

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female

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
Dose / conc.:
4 500 other: mg/kg bw
Remarks:
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

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, the 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. 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 post application 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 substance did not show any clastogenic effects in mice bone marrow cells (IUCLID, 2000).