6-methoxy-m-toluidine

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed research study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Micronucleus assay using the peripheral blood as described by Hayashi et al., 1990; CSGMT, 1992)

Deviations:

not applicable

Principles of method if other than guideline:

Five male ICR mice were randomly assigned to each treatment group. p-Cresidine was given po twice at 24-h intervals in 10 ml/kg at 250, 500, 1000, or 2000 mg/kg per dose. The treatment range was based on the ip maximum tolerated dose (MTD, >2000 mg/kg), determined by the preliminary acute study. In the positive control group, MMC at 0.5 mg/kg was injected intraperitoneally once. The micronucleus assay using the peripheral blood was performed as described previously (Hayashi et ah, 1990; CSGMT, 1992).

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

6-methoxy-m-toluidine

EC Number:

204-419-1

EC Name:

6-methoxy-m-toluidine

Cas Number:

120-71-8

Molecular formula:

C8H11NO

IUPAC Name:

2-methoxy-5-methylaniline

Details on test material:

- Name of test material (as cited in study report): p-Cresidine
- Analytical purity: >99%

Test animals

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

Mice were used at 8 weeks of age, after 1 week acclimatization period. They were housed at 25 +- 2°C and 55 +-5% humidity under a 12 h light/dark cycle and were given commercial pellet and tap water ad libitum.

Administration / exposure

Route of administration:

other: double oral

Vehicle:

p-Cresidine and MMC (positive control) were dissolved in olive oil and phsiological saline respectively, immediately before administration

Duration of treatment / exposure:

p-Cresidine was given po twice at 24 h intervals in 10 ml/kg at 250, 500, 1000 or 2000 mg/kg per dose

Frequency of treatment:

twice at 24 h intervals

Post exposure period:

sampling time 24, 48, and 72 h after the second treatment

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
250
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
500
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
1000
Basis:
actual ingested

Doses / concentrations 4

Remarks:

Doses / Concentrations:
2000
Basis:
actual ingested

No. of animals per sex per dose:

5

Control animals:

yes

Positive control(s):

Mitomycin C at 0,5 mg/kg was injected intraperitoneally once.

Examinations

Tissues and cell types examined:

reticulocytes in the mouse peripheral blood

Evaluation criteria:

positive: statistically significant increased incidence of micronucleated reticulocytes

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

yes

Remarks:

Two mice died within 24 h of the second dose of p-cresidine at 2000 mg/kg

Vehicle controls validity:

not examined

Negative controls validity:

other: nagative control = sample before dosing: valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The test chemical does not induce micronulclei in male ICR mice up to the lethal dose.

Executive summary:

In this report, the clastogenicity of p-cresidine was evaluated in the mouse peripheral blood micronucleus test. The test chemical does not induce micronulclei in male ICR mice up to the lethal dose.