Undec-10-enoic acid

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-09-22 till 1987-12-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

1893

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

Remarks:

(bone marrow)

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enoic acid

EC Number:

203-965-8

EC Name:

Undec-10-enoic acid

Cas Number:

112-38-9

Molecular formula:

C11H20O2

IUPAC Name:

undec-10-enoic acid

Details on test material:

- Physical state: solid
- Batch 1410

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chalres River, Cléon, France
- Age at study initiation: 7 weeks
- Weight at study initiation: 29g (males) 22g (females)
- Housing: wire mesh bottom stainless steel cages
- Diet / Water (e.g. ad libitum): ad lib.
- Acclimation period:2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 60+/-10
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

10% gum arabic, freshly prepared

Details on exposure:

no

Duration of treatment / exposure:

single

Frequency of treatment:

single treatment on day 1

Post exposure period:

24, 48 and 72 h

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 000 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

2 000 mg/kg bw/day

Doses / concentrations 3

Dose / conc.:

4 000 mg/kg bw/day

No. of animals per sex per dose:

15

Control animals:

yes, concurrent vehicle

Positive control(s):

Cyclophosphamide ip (15 males and 15 females)

Examinations

Tissues and cell types examined:

bone marrow smears

Details of tissue and slide preparation:

DETAILS OF SLIDE PREPARATION:
both femurs severed, bone marrow flushed out with calf`s serum, cells opbtained by mild centrifugation and spread over slides after mild homogenization; fixed with methanol and stained automatically

Evaluation criteria:

An increase in micronucleated polychromatic cells shows a possible genotoxic effect.
When the ratio PCE / NCE decreases, this represents marrow cytotoxicity.

Statistics:

no

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Remarks:

for all doses similar to that of control animals

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RESULTS OF DEFINITIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): similar for control and 24/48h-groups; 72 h not evaluated
- Appropriateness of dose levels and route: 3 cases of mortality (high dose, only males, 24/48h)

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions, undecylenic acid did not reveal any in vivo genotoxic activity in the micronucleus test in mice.

Executive summary:

The in vivo genotoxic potential of undecylenic acid was assessed in the mouse by micronucleus test according to OECD guideline 474 and EU method B.12. Undecylenic acid was administered once by oral gavage at dose levels of 1,2 and 4 g/kg bw to CD-1 mice. Each group consisted of 15 male and 15 female animals. Cyclophosphamide served as positive control.

No clinical signs were reported throughout the study, but three maled of the highest dose group were found dead 24 or 72 h after treatment. The PCE/NCE ratio obtained in all treated animals (24 and 48h after treatment) was similar to that of the control animals, and evaluation of the samples obtained 72 h after treatment was not considered necessary.

Under the experimental conditions, undecylenic acid did not reveal any in vivo genotoxic activity in the micronucleaus test in mice.