Fluometuron

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 July to 04 August 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, §81-4 (1984) = EEC B.5 (1992). USA TSCA, Section HG ‘Primary Eye 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 81-4 (Acute Eye Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- group of six New Zealand white rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.54 - 3.09 kg
- age:twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 16 - 22°C

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1ml of the test material fluometuron, purity 96.8%

Duration of treatment / exposure:

1, 24, 48, 72 hour

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

six

Details on study design:

Six New Zealand White rabbits each received 0.1ml of the test material (as measured by gently compacting the required volume into an adapted syringe) by a singular ocular instillation without irrigation to the lower everted lid of one eye of each animal. The upper and lower eyelids were held together for about one second immediatly after application, to prevent loss of the test material, and then released.
The left eye remained untreated and was used for control purposes.
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treeatment. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: maximum group mean score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

0 - 4

Max. score:

4

Remarks on result:

other: mean irritancy score for the 24 and 72 hours was 0-0.3

Results 2

Irritation parameter:

overall irritation score

Remarks:

mean irritancy score

Basis:

mean

Time point:

other: 24,72 hours

Score:

>= 0 - <= 3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: no adverse effects were noted at the 72-hour observation and the study was terminated

Irritant / corrosive response data:

No adverse corneal or iridial effects were noted during the study period.
Minimal conjunctival irritation was noted in all rabbits one hour after treatment and in two treated eyes after 24 hours. No other adverse conjunctival effects were noted see Table 7.3.2.-01

Other effects:

no other effects were recognized

Any other information on results incl. tables

Table 7.3.2.-01: Individual and mean eye irritation scores

 

 

Animal No.	Region of eye	Hours
		1	24	48	72
189	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 1 1	0 0   0 1 0 0	0 0   0 0 0 0	0 0   0 0 0 0
207	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 1 1	0 0   0 0 0 0	0 0   0 0 0 0	0 0   0 0 0 0
168	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 0 0	0 0   0 0 0 0	0 0   0 0 0 0	0 0   0 0 0 0
146	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 0 0	0 0   0 0 0 0	0 0   0 0 0 0	0 0   0 0 0 0
206	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 1 1	0 0   0 0 0 0	0 0   0 0 0 0	0 0   0 0 0 0
182	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 0 0	0 0   0 1 0 0	0 0   0 0 0 0	0 0   0 0 0 0
Mean score	Cornea – degree of opacity area of opacity                        Iris Conjunctiva – redness chemosis discharge	0 0   0 1 0.5 0.5	0 0   0 0.3 0 0	0 0   0 0 0 0	0 0   0 0 0 0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information According to the provisions of regulation 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

In this study the mean irritancy score for the 24 and 72 hours was 0-0.3. Therefore, fluometuron was only minimally and transiently irritating to the rabbit eye.In accordance with the provisions of regulation 1272/2008, Annex I, 3.3, it is proposed classification is not required. It is proposed fluometuron technical it is not classified as an eye irritant.

Executive summary:

1. A study was performed to assess the irritancy potential of the test material to the eye 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 application of the test material to the non-irrigated eye of six rabbits produced minimal conjunctival irritation in all treated eyes. No other adverse effects were noted.

 

3. The test material produced a maximum group mean score of 4.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.