Fluometuron

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 August to 16 August 1984

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, §81-2 (1984) = EEC B.3 (1992) USA TSCA, Section HG ‘Acute Dermal 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 81-2 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- group of six New Zealand white rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.42 - 3.38 kg
- age:twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 17 - 22°C

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

PROCEDURE
Approximately twenty-four hours prior to the commencement of the test, each group of six rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of a 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approximate size patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period of four hours.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

Duration of exposure:

4 hours

Doses:

singl dermal doses: 0.5 g, semi-occluded application of test material

No. of animals per sex per dose:

one group of

Control animals:

no

Details on study design:

Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later, the test sites were examined for evidence of primary irritation and scorde according the scale i.e. Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin Texas, "The Appraisal of the safety of the Chemicals in Foods, Drugs and Cosmetics".

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortalities

Clinical signs:

other: no irritation reactions were noted at the sites of application

Gross pathology:

no abnormalities were noted in the necropsy

Any other information on results incl. tables

7.2.3-01          Acute dermal toxicity of fluometuron in rabbits

Males		Females
Dose	Mortality	Dose	Mortality
2000 mg/kg	0/5	2000 mg/kg	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information In accordance with the provisions of regulation 1272/2008, classification is not required Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) to rabbits of fluometuron technical was demonstrated to be greater than 2000 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 assess the acute dermal toxicity of the test material in the New Zealand White rabbit. The study was designed to comply with the requirements of the U.S. Environmental Protection Agency (EPA).

 

2. A group of ten animals (ftve males and five females) was given a single, 24-hour. semi occluded application of the test material to intact skin, at a dose level of 2000 mg/kg bodyweight.

 

3. There were no deaths. No evidence of systemic toxicity or skin irritation was noted during the study period.

 

4. No toxicologically significant effects on bodyweight were noted during the study.

 

5. Ho abnormalities were noted at necropsy of animals killed at the end of the study.

 

6. The acute dermal median lethal dose (LD50) of the test material in the New Zealand White rabbit was found to be greater than 2000 mg/kg bodyweight.