Hydroxyoctadecanoic acid, monoester with glycerol

Genetic toxicity: in vivo

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Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April, 1988-July, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study by GLP

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Castor oil (CAS 8001-79-4), lot #L-5G30-01, was obtained from Cas Chemical, Inc., Bayonne, NJ. Purity analysis indicated that it was consistent with the USP specifications and the reported composition for castor oil: Analysis was conducted by Midwest Research Institute (MRI), in Kansas City, MO, utilizing infrared, UV/Vis and NMR spectroscopy, Karl Fischer water analysis, TLC and HPLC, and a battery of USP standard analyses for castor oil.

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals weight-randomized into groups by sex, assigned to cages and cages assigned to dose groups. Mice were caged individually.
Animals obtained from Simonsen Laboratories, Gilroy CA, USA
Animal room temperature: 68-76 degrees F, relative humidiay 42-72%.
Fluorescent light 12 h/day, 10 room air changes/hour.
Age at initiation of study: 6 weeks
Quaranteed 15 days prior to study.

Administration / exposure

Route of administration:

oral: feed

Vehicle:

NIH 07, available ad libitum

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION
- Rate of preparation of diet (frequency): Prepared every 21 days. Feed within animal cages was changed every 3 days.
- Mixing appropriate amounts with (Type of food): NIH07, ad lib
- Storage temperature of food: at 5degrees C, in the dark

VEHICLE
- Justification for use and choice of vehicle (if other than water): NIH07, ad lib

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

ad libitum

Post exposure period:

not applicable; test is performed on peripheral blood from a subchronic study.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.62 other: % in diet

Remarks:

Doses / Concentrations:
0, 0.62%, 1.25%, 2.5%, 5.0% and 10%
Basis:
nominal conc.

Doses / concentrations 2

Dose / conc.:

1.25 other: % in diet

Doses / concentrations 3

Dose / conc.:

2.5 other: % in diet

Doses / concentrations 4

Dose / conc.:

5 other: % in diet

Doses / concentrations 5

Dose / conc.:

10 other: % in diet

No. of animals per sex per dose:

20

Control animals:

yes, plain diet

Positive control(s):

Urethane (0.2%) was used as a positive control. Three male mice were dosed for 4 weeks with this positive control in the drinking water.

Examinations

Tissues and cell types examined:

Peripheral blood, obtained at sacrifice from cardiac puncture.

Details of tissue and slide preparation:

Slides were stained with Hoechst 33258/pyronin Y, according to the method of MacGregor, et al., 1983). At least 2000 PCE and 10,000 NCE from each animal were scored for micronuclei.

Statistics:

Values are Mean +/- Standard Error of the Mean. Significant differences were assessed using Shirley's test (Shirley, 1977), at p <0.05.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Remarks:

no increase in micronucleated erythrocytes

Toxicity:

no effects

Remarks:

no adverse hematologic effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No significant elevation in the frequency of micronucleated erythrocytes was observed in either male or female mice administered castor oil in dosed feed.

Applicant's summary and conclusion

Conclusions:

Castor oil, when administered in the feed to B6C3F1 mice for 13 weeks, did not result in an increase in micronucleated erythrocytes. The substance is not a genotoxicant, under the conditions of the study.