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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-March-2002 to 03-April-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

solid: particulate/powder

Remarks:

Appearance: white powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were approximately ten weeks of age when treatment was administered. Feed (PMI Certified Rodent Diet 5002) was provided continuously for ad libitum consumption during the acclimation period and throughout the study prior to dosing (with the exception of the overnight fasting period), as was tap water. Feed and water were periodically sampled and analyzed for a variety of potential impurities. Upon receipt, animals were examined and sacrificed if general appearance and/or behavior were considered abnormal. Those animals considered acceptable were individually housed in single cages and acclimated to their ambient laboratory conditions (set for a temperature of 19° to 25°C (66° to 77°F), relative humidity 30-70%, 12-hr light/dark cycles, an average of at least 11 air changes per hour) prior to placement on the study. For the holding period, animal care personnel observed the animals at least once daily for moribundity and mortality. One animal was sacrificed due to moribundity.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized water

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

6 animals per sex per dose

Control animals:

yes

Remarks:

vehicle only

Details on study design:

The oral route of exposure was employed in general accordance with the test guidelines for an acute oral toxicity study, based on this being a possible route of human exposure. Doses were prepared by weighing and mixing the appropriate quantity of Triflumuron and vehicle (10 mL/kg deionized water). Control and treated rats were treated in an identical manner, except controls received vehicle only. Each dose group consisted of 6 animals/sex. Dosing preparations (test substance plus vehicle) were stirred continuously during the dosing process and were administered as a single oral dose, utilizing appropriate dosing equipment, after which the animals were returned to their cages. Animals were sacrificed on Day 14. Dose amounts were based on individual body weights determined on Day 0 (day of exposure).

Cage-side observations were conducted at least once daily for mortality or clinical signs of moribundity with the following exception; On Day 12, animals were not observed for mortality, moribundity. No animals were sacrificed due to moribundity. Detailed physical examinations for clinical signs were carried out at least twice daily for three days (Day 0, 1 and 2) and once daily thereafter through Day 14 with the following exceptions; On Day 4, all animals were observed, however, observations for the female 5000 mg/kg level were not recorded, and on Day 12 animals were not observed for clinical signs of toxicity. These examinations were performed at approximately the same time of day. Body weight determinations were performed weekly.

Statistics:

Not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: other: There were no mortalities or compound-related clinical signs in the control or 5000 mg/kg dose groups. Clinical signs unrelated to the test compound included rough coat and thinning hair.

Gross pathology:

Gross observational findings consisted of alopecia in one control male.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

As no mortality was observed, an LD50 of greater than 5000 mg/kg was established in male and female rats following acute oral exposure to triflumuron.

Executive summary:

In a study performed to GLP and OECD 401, triflumuron formulated in deionised water (10 mL/kg bw) was administered to groups of fasted male and female rats by single gavage dose. Rats were observed for 14 days. The administration of triflumuron did not elicit any treatment-related findings in mortality, clinical signs, body weight and macroscopic pathology.  The acute oral LD₅₀ of triflumuron was therefore found to be >5000 mg/kg bw.