Fluometuron

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 July to 03 September 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study The experiments were done according to the EPA FIFRA, Subdivision F, §81-1 (1984) = EEC B.1 (1992) USA TSCA, Section HG ‘Acute Oral Toxicity Study’

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fluometuron

EC Number:

218-500-4

EC Name:

Fluometuron

Cas Number:

2164-17-2

Molecular formula:

C10H11F3N2O

IUPAC Name:

fluometuron

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: fluometuron, 1,1-dimethyl-3-[3-(trifluoromethyl)phenyl]urea
- Physical state white powder
- Analytical purity:96.8% (w/w)
- Batch number: batch no. 1223
- Date of arrival: 12 July 1989
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- groups of five male and five female fasted Sprague-Dawley fasted rats
- Source: Bantin & Kingman Ltd. Grinston, Aldborrough, Hull, U.K.
- weight: males: 120-135 g, females: 120-126 g
- age: five to eight weeks
- free access to mains drinking water and food
- room tempersture: 22-25°C

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

solution/suspension

Details on oral exposure:

All animals were dosed once only by gavage using a metal cannula attached to a gratuated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

A group of ten rats (five males and five females) was dosed as follows: 5000 mg/kg (Dose Level), 500 mg/ml (Concentration), 10 ml/kg (Dose Volume).

No. of animals per sex per dose:

one group of five male and five female rats, 10 animals/dose

Control animals:

no

Details on study design:

Animals were observed 1 and 4 hours after dosing. The observation period was for 14 days following dosing.
Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
EVALUTION OF DATA:
Using the mortality data obtained, an estimate of acute oral median lethal dose (LD50) of the test material was made.
Clinical observations, bodyweight and necropsy were examined for any adverse but non-lethal effects resulting from treatment.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

dissolved

Remarks:

suspension in arachis oil

Mortality:

There were no mortalities observed (Table 1).

Clinical signs:

other: There were no clinical signs of reaction to treatment. All animals were comatose at one and four hours after treatment, decreased respiratory rate was also noted at four hours, however all animals recovered and signs of toxicity were confined to hunched p

Gross pathology:

No abnormalities were recorded at post mortem examination at study termination.

Other findings:

Fluometuron is of very low acute toxicity to rats, as the LD50 is greater than 5000 mg/kg bw.

Any other information on results incl. tables

Table 1: Acute oral toxicity of fluometuron in rats

Males		Females
Dose	Mortality	Dose	Mortality
5000 mg/kg	0/5	5000 mg/kg	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information In accordance in accordance with the provisions of regulation 1272/2008, Annex I, 3.1, it is proposed classification is not required. Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of fluometuron technical is greater than 5000 mg/kg bodyweight. In accordance with the provisions of regulation 1272/2008, Annex I, 3.1, it is proposed classification is not required.

Executive summary:

1. A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution/suspension in arachis oil B.P., in the Sprague-Dawley strain rat. The study was designed to comply with the requirements of the U.S. Environmental Protection Agency (EPA).

2. A group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation at a dose level of 5000 mg/kg bodyweight.

3. There were no deaths. All animals were comatose, with or without decreased respiratory rate, one and four hours after treatment. Animals recovered and appeared normal two to three days after treatment.

4. All animals showed expected gain in bodyweight during the study period.

5. No abnormalities were noted at necropsy of animals killed at the end of the study.

6. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 5000 mg/kg bodyweight.