3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Japanese Industrial Safety and Health Law guideline

Principles of method if other than guideline:

None

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

EC Number:

413-330-9

EC Name:

3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

Cas Number:

134724-55-3

Molecular formula:

C27H20O6

IUPAC Name:

6-{4-[(oxolan-2-yl)methoxy]phenyl}-12-phenyl-4,10-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1(12),2,6,8-tetraene-5,11-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

None

Test animals

Species:

mouse

Strain:

not specified

Details on species / strain selection:

None

Sex:

male

Details on test animals or test system and environmental conditions:

Specific Pathogen Free(SPF) male mice of BDF1(C57BL/6xDBA/2) strain Pilot study Main Study a) Receipt of animals Feb. 15, 1990 March 15, 1990 (age) (8 weeks old) (8 weeks old)b) Number ordered Male: 50 Male: 45c) Date of administration Feb. 26, 1990 March 26, 1990 (age) (9 weeks old) (9 weeks old)d) Body weight at 25.7-27.9g 24.3-28.7g administration period

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

Corn oil

Details on exposure:

None

Duration of treatment / exposure:

None

Frequency of treatment:

None

Post exposure period:

None

No. of animals per sex per dose:

Female: 1250 mg/kg; No. of animals: ; Sacrifice times: hoursFemale: 2500 mg/kg; No. of animals: ; Sacrifice times: hoursFemale: 5000 mg/kg; No. of animals: ; Sacrifice times: hours

Positive control(s):

Mitomycin C with saline

Examinations

Tissues and cell types examined:

None

Details of tissue and slide preparation:

None

Evaluation criteria:

None

Statistics:

None

Results and discussion

Test results

Key result

Sex:

female

Toxicity:

yes

Remarks:

Doses producing toxicity:>= 2500 mg/kg

Additional information on results:

Observations:The test substance induced significant cytotoxicity in mouse bone marrow cells at 5000 mg/kg (p<0.005). However, the incidence of MNPCE at any of the dose levels was comparable to that in the control group and there was no statistically significant increase.Mitomycin C-treated (2mg/kg) mice, the positive control, caused a statistically significant increase in the frequency of MNPCE. clinical symptoms: no lethal effects.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Negative is the in vivo chromosome aberration test.

Executive summary:

The in-vivo mouse micronucleus test was conducted using BDF (C57BL/6xDBA/2) hybrid to assess the potential of D-523 to induce micronucleated erythrocyte. Dose levels of 1250, 2500 and 5000 mg/kg were selected on the basis of a erythrocytes (MNPCE) and polychromatic erythrocytes (PCE) were counted 24 hours after a single intraperitoneal injection of FAT 40554.

The test substance, FAT 40554, induced significant cytotoxicity in mouse bone marrow cells at 5000 mg/kg (p<0.05). However, the incidence of MNPCE at any of the dose levels and comparable to that in the solvent control group and there was no statisticakky significant increase.