Fluometuron

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 to 28 July 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, §81-5 (1984) = EEC B.4 (1992). USA TSCA, Section HG ‘Primary Dermal Irritation’

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

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

Details on test animals or test system and environmental conditions:

- group of six New Zealand white rabbits (five males/ one female)
- 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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

distilled

Controls:

no

Amount / concentration applied:

singl dermal doses: 0.5 g, semi-occluded application of test material, moistened with distilled water

Duration of treatment / exposure:

4 hours

Observation period:

Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later

Number of animals:

six

Details on study design:

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.
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 score 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

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24 h

Score:

0.2

Max. score:

0.2

Reversibility:

no data

Remarks on result:

other: primary irritation index: 0.08

Irritant / corrosive response data:

A very slight erythema was noted in one animal at one and 24 hours after patch removal. No other adverse affects were noted see Table 7.3.1.-01

Any other information on results incl. tables

Table 7.3.1.-01: Individual and mean skin irritation scores

Animal No.	Erythema and Eschar (E) Oedema (O)	Hours
		1	24	48	72
140	E O	0 0	0 0	0 0	0 0
144	E O	0 0	0 0	0 0	0 0
148	E O	1 0	1 0	0 0	0 0
161	E O	0 0	0 0	0 0	0 0
174	E O	0 0	0 0	0 0	0 0
180	E O	0 0	0 0	0 0	0 0
Mean score	E O	- -	0.2 0	0 0	0 0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information in accordance with the provisions of regulation 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

In this study the mean skin scores for 24 to 72 hours after removal of the test article were < 2, therefore, in accordance with the provisions of regulation 1272/2008, Annex I, 3.2 , it is proposed fluometuron is not classified as a skin irritant.

Executive summary:

1. A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The study was designed to comply with the requirements of the U.S.A. Environmental Protection Agency (EPA).

 

2. A single 4-hour. semi-occluded application of the test material to the skin of six rabbits produced very slight erythema at one treated skin site, No other adverse skin responses were noted

 

3. The test material produced a primary irritation index of 0.08 and was classified as a mild irritant to rabbit skin.