2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

The study is pre-guideline, non-GLP and reported in limited detail.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test: A dominant lethal assay on male mice to determine mutagenic potential of a test substance.
- Short description of test conditions: Male test animals were given a single oral dose of the test substance and water and pelleted feed were provided ad libitum. Females remained untreated and were solely for reproductive purposes.
- Parameters analysed / observed: fertilisation quota, pre-implantation loss, post-implantation loss.

GLP compliance:

no

Remarks:

Test was conducted pre-GLP

Type of assay:

rodent dominant lethal assay

Test material

Test material information

1

Reference substance name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

EC Number:

264-980-3

EC Name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Cas Number:

64628-44-0

Molecular formula:

C15H10ClF3N2O3

IUPAC Name:

3-(2-chlorobenzoyl)-1-[4-(trifluoromethoxy)phenyl]urea

Test material form:

not specified

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

At the start of the study, the male mice weighed 31 to 42 grams, and the females weighed 28 to 33 grams. The mice were between 8 and 12 weeks old. Each group consisted of 50 males and 600 females. The mice were housed in Type I Makrolon cages, as follows: a) During mating, each male was caged with one virgin female. b) After mating, the females were caged singly. Standardized housing conditions with 12 hours of electric light daily, room temperature of 20 to 26°C and average relative humidity of approx. 60%. The mice were fed pelleted ®Altromin Laboratory Small Animal Diet and tap water ad libitum.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

yes - 0.5 % Cremophor emulsion used with test substance for oral dose.

Details on exposure:

All the females used in the study remained untreated. The males of the treated group received a single oral dose of 400 mg triflumuron /kg body weight in 0.5 % Cremophor emulsion, administered in a volume of 20 mL/kg body weight. The males of the control group received 0.5 % Cremophor emulsion containing no triflumuron , in a volume equivalent to that given to the treated mice.

Duration of treatment / exposure:

Not applicable for single dose study

Doses / concentrations

Dose / conc.:

20 other: mL/kg bw

Remarks:

male mice only

Control animals:

yes, concurrent vehicle

Examinations

Evaluation criteria:

After an interval of about 14 days counted from midway through a mating period, the uterus of each female was examined to determine pre-implantation and post-implantation losses, the criteria of the assessment. For this purpose, the total implants as well as the live and the dead implants (sum of the deciduomata, the resorptions and the dead embryos) and the Corpora lutea were counted.

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Additional information on results:

The dose tested was tolerated well. It did not lead to toxic signs or mortalities. The mice's fertility was not affected by the dose used. No treatment-related variations between control and treatment group were noted in respect to the parameters relevant to assessment of a mutagenic effect (dead implants, live implants, total implants, pre-implantation loss).

Applicant's summary and conclusion

Conclusions:

Triflumuron was not mutagenic in the dominant lethal test on male mice.

Executive summary:

A dominant lethal assay was conducted on male mice to evaluate triflumuron for mutagenic potential. The male mice each received a single oral dose of triflumuron at a level of 400 mg/kg bw. The tested dose was well tolerated, and it did not cause any symptoms of poisoning or any mortalities. The fertility of the mice was not affected by the tested dose. No treatment-related differences were seen between the treated group and the controls with respect to those parameters of importance to the assessment of a mutagenic effect (dead implants, viable implants, total implants, pre-implantation loss). The dominant lethal assay on male mice thus provided no indication of triflumuron having a mutagenic effect at the oral dose level of 400 mg/kg body weight.