2-(4-methyl-3-pentenyl)anthraquinone

Genetic toxicity: in vivo

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is a well-documented, GLP-guideline study performed to standard protocols.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid - liquid: suspension

Details on test material:

Test substance in suspension with peanut oil, administered by gavage.

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: males 27.1-33.2 g, females 23.9-29.3 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-22.0°C
- Humidity (%): 53-57%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24.09.1996 To: 26.09.1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

negative control: peanut oil
positive control: cyclophosphamide

Details on exposure:

All animals were given a single oral administration of 10ml/kg bw by gavage.
The test material group animals (male and fermale) received the maximum tolerated dose (1780 mg/kg bw) suspended in peanut oil.
The positive control animals received 31.6mg/kg bw cyclophosphamide dissolved in 0.9% saline solution.

Frequency of treatment:

Single dose by gavage.

Post exposure period:

Animals were sampled at 24 and 48 hours post-treatment.

Doses / concentrations

Remarks:

Doses / Concentrations:
1780 mg/kg bw
Basis:
actual ingested
by gavage

No. of animals per sex per dose:

Negative Controls:12 males and 12 Females
Positive Control: 6 males and 6 Females
Test Material Group: 14 males and 14 Females

Control animals:

yes, concurrent vehicle

Positive control(s):

12 animals (6male, 6female) received a dose of 31.6mg/kg bw cyclophosphamide dissolved in 0.9% saline solution.

Examinations

Tissues and cell types examined:

Bone marrow from femur.

Details of tissue and slide preparation:

Bone marrow cells were flushed into centrifuge tubes with 1.5 ml fetal calf serum and centrifuged. The supernatant was discarded and a small drop of marrow serum was smeared onto slides. Smears were stained using the panoptic stain method (Pappenheim).

Results and discussion

Test results

Test results 1

Sex:

female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Sex:

male

Genotoxicity:

negative

Toxicity:

yes

Remarks:

Slight hypokinesia and sunken sides

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Test-material related symptoms were observed only in male animals, manifesting as slight hypokinesia and sunken sides.
Female animals showed no clinical symptoms.
No test material animals died.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The test substance at 1780mg/kg body weight (Males and Females, single oral administration) is non-mutagenic in the mouse micronucleus test under the described conditions.