Prometryn

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: gene mutation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

29 Sep 1987 to 6 Oct 1988

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:

26 May 1983

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

19 September 1984

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)

Version / remarks:

June 19, 1987

GLP compliance:

yes

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Prometryn

EC Number:

230-711-3

EC Name:

Prometryn

Cas Number:

7287-19-6

Molecular formula:

C10H19N5S

IUPAC Name:

6-(methylsulfanyl)-N2,N4-di(propan-2-yl)-1,3,5-triazine-2,4-diamine

Test material form:

solid: particulate/powder

Test animals

Species:

mouse

Strain:

Tif:MAGf

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The results indicate that under the given experimental conditions (OECD 474, GLP) no evidence of mutagenic effects was obtained in mice treated with the test material.

Executive summary:

The test material was administered by oral gavage to groups of 8 female and 8 male mice each in the control, 480, 960 and 1920 mg/kg dose groups in a GLP compliant study performed according to OECD guideline 474. In the first part of this study the animals were treated once with the highest applicable dose of 1920 mg/kg and sacrificed 16, 24 and 48 hours thereafter. In the second part of this study the animals were treated once with doses of 480, 960 and 1920 mg/kg and sacrificed 24 hours thereafter. Smears were prepared from the bone marrow of all treated animals. The test material in suspension was analysed to confirm the intended concentration to be used in the mutagenicity tests. The measured concentrations were in agreement with the nominal concentrations. The experiments were performed to evaluate any mutagenic effect on polychromatic erythrocytes in bone marrow cells in vivo. In the first experiment the bone marrow smears for the animals treated with the dose of 1920 mg/kg of the test material showed no statistically significant increase (p>0.05) in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at the sampling times of 16, 24 and 48 hours. Therefore, the animals were sacrificed 24 hours after treatment in the second part of the experiment. Also in this second experiment the bone marrow smears from the animals treated with 480, 960 and 1920 mg/kg of test material showed no statistically significant increase (p>0.05) in the number of micronucleated polychromatic erythrocytes in comparison with the animals of the negative control group. The respective positive control experiments with cyclophosphamide (64 mg/kg) yielded an average of 2.22% (first part) and 2.25% (second part) polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.06% and 0.03% respectively) treated with the vehicle (CMC 0.5%) alone.

The results indicate that under the given experimental conditions no evidence of mutagenic effects was obtained in mice treated with the test material.