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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

in vivo mammalian germ cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
The study is pre-guideline, non-GLP and reported in limited detail.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
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:
Test was conducted pre-GLP
Type of assay:
rodent dominant lethal assay

Test material

Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
not specified

Test animals

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
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
male mice only
Control animals:
yes, concurrent vehicle


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
no effects
Vehicle controls validity:
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

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.