β-methyl-3-(1-methylethyl)benzenepropanal

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:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

β-methyl-3-(1-methylethyl)benzenepropanal

EC Number:

412-050-4

EC Name:

β-methyl-3-(1-methylethyl)benzenepropanal

Cas Number:

125109-85-5

Molecular formula:

C13H18O

IUPAC Name:

3-[3-(propan-2-yl)phenyl]butanal

Test material form:

liquid

Specific details on test material used for the study:

Batch number 185809
Purity 97.9%

Test animals

Species:

mouse

Strain:

other: Fullinsdorf Moro Albino mice

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Standard Suspension Vehicle (SSV)

Details on exposure:

Once by oral gavage

Duration of treatment / exposure:

Once by oral gavage, exanimations at 24, 48 and 72 hours for the high dose and 24 hours only for the low dose

Frequency of treatment:

Single treatment

Post exposure period:

Up to 72 hours

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 000 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

2 000 mg/kg bw/day

No. of animals per sex per dose:

18 Males and 18 Females for the negative control
6M and 6F at 1000mg/kg -> 5M+5F were evaluated
18M and 18F at 2000mg/kg -> 15M and 15F were evaluated
6M and 6F for the positive control -> 5M and 5F were evaluated

Control animals:

yes, concurrent vehicle

Positive control(s):

Positive control: Procarbazine hydrochloride

Examinations

Tissues and cell types examined:

Erythrocytes of the bone marrow of mice

Details of tissue and slide preparation:

Sampling times at 24, 48 and 72 hours for the high dose and 24 hours only for the low dose.
2 slides per animal treated were made.
1000 PCE were per animal.

Evaluation criteria:

The ratio of PCE/NCE was determined on 1000 counts of erythrocytes.

Statistics:

The observed yields of MN-PCE were evaluated by means of the Mann-Whitney-U-test.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions described in this report, the test item did not show any genotoxic activity in the mouse bone marrow cells.Thus the test item is is considered to show no genotoxic effects under the described experimental conditions..