Linseed oil, ester with pentaerythritol

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 applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1994

Materials and methods

Principles of method if other than guideline:

Three groups of Balb/C female mice were dosed with red palm oil supernatant and red palm oil sediment and a mixture of two, respectively, for 5 consecutive d. A negative group was dosed with corn oil and the positive control group was injected intraperitoneally with cyclophosphamide. 24 h after the last treatment each animal were killed by cervical dislocation. The femurs from each animal were dissected and stripped clean of muscles, for cytological preparations from bone marrow. For each animal 100 bone marrow metaphase cells were analysed for evaluation of chromosome aberration and 1000 cells for determination of mitotic index. The types of chromosomal aberrations considered were chromatid and chromosome gaps, breaks, fragments and exchanges. The mitotic index was statistically analysed by the x^2 test and the frequency of chromosome aberration was analysed using a conditional test based on approximation to the Poissin distribution.

GLP compliance:

not specified

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

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): Red palm oil (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

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-10 wk
- Weight at study initiation: 25-30 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ̊C
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Not applicable

Details on exposure:

Not applicable

Duration of treatment / exposure:

5 d

Frequency of treatment:

daily

Post exposure period:

None

Doses / concentrations

Dose / conc.:

4 500 mg/kg bw/day

Remarks:

Basis:
nominal conc.

No. of animals per sex per dose:

10

Control animals:

yes

Positive control(s):

cyclophosphamide
- Route of administration: injection intraperitoneally
- Doses / concentrations: 20 mg/kg bw

Examinations

Tissues and cell types examined:

Bone marrow metaphase cells

Details of tissue and slide preparation:

DETAILS OF SLIDE PREPARATION: The slides were stained in 10% aqueous Giemsa solution

Evaluation criteria:

The types of chromosomal aberrations considered were chromatid and chromosome gaps, breaks, fragments and exchanges

Statistics:

The mitotic index was statistically analysed by the chi square test and the frequency of chromosome aberration was analysed using a conditional test based on an approximation to the Poisson distribution.

Results and discussion

Test results

Key result

Sex:

female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the study conditions, test substance did not induce chromosomal aberrations in mouse bone marrow cells, in vivo, after daily expositions of 4500 mg/kg bw/d. Furthermore, this dose did not promote any alteration in the mitotic index, suggesting that test substance had no cytotoxic effects.

Executive summary:

A study was conducted to evaluate possible clastogenic and cytotoxic activity of glycerides, C16-18 and C18-unsatd. (in the form of red palm oil) in mouse bone marrow cells in vivo. Three groups of Balb/C female mice, 10 per group, were dosed with test substance supernatant, test substance sediment or a mixture of the two at a dose level of 4500 mg/kg bw/d by gavage for 5 consecutive days. A negative group was dosed (by gavage) with corn oil and the positive control group was injected intraperitoneally with cyclophosphamide. 24 h after the last treatment each animal were killed by cervical dislocation. The femurs from each animal were dissected and stripped clean of muscles, for cytological preparations from bone marrow. For each animal 100 bone marrow metaphase cells were analysed for evaluation of chromosome aberration and 1000 cells for determination of mitotic index. No statistically significant differences were observed in the frequency of chromosomal aberrations and the mitotic index in bone marrow samples in any of the three groups. Under the study conditions, test substance did not induce chromosomal aberrations in mouse bone marrow cells, in vivo, after daily expositions of 4500 mg/kg bw/d. Furthermore, this dose did not promote any alteration in the mitotic index, suggesting that test substance had no cytotoxic effects (Oliveria, 1994).