Fluometuron

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 July to 26 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, §81-6 (1984) = EEC B.6 (1996).

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 81-6 (Skin Sensitisation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

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: 98.3% (w/w)
- Batch number: batch no.1223
- Date of arrival: 12 July 1989
- Storage conditions: room temperature
For the purpose of this study the test material was used as follows:
Topical Induction: 50% (w/w) in arachis oil B.P.
Topical Challenge: 50% (w/w) in arachis oil B.P.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

- group of thirty (twenty treated and ten control) female guinea pigs of the Dunkin-Hartley strain
- Source: David Hall Ltd., Moston, Burton-on-Trent, Staffordshire, U.K.
- weight: 333 - 410 g
- age: five to eight weeks old
- free access to mains drinking water and food
- animal room temperature: 21 - 24°C
- relative humidity: 65 - 70%

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Induction 2

Concentration / amount:

50% (w/w)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Challenge 2

Concentration / amount:

50% (w/w)

No. of animals per dose:

20 treated, 10 control

Details on study design:

Based on the results of preliminary studies the following dose levels were selected:
Induction topical application: 50% (w/w) in arachis oil B.P.
Thirty (twenty treated and ten control) albino female guinea pigs of the Dunkin-Hartley strain were used for the main study. The induction topical application was applied to the left shorn flank and covered by an occlusive dressing for 6 hours. The induction procedure was repeated at the same site on Days 7 and 14, giving a total of 3 induction applications at weekly intervals.

Challenge controls:

Based on the results of preliminary studies the following dose levels were selected:
Topical challenge: 50% (w/w) in arachis oil B.P.
The challenge application was applied to the right shorn flank on day 28, and occluded for 6 hours. Observation of any erythematous reactions were quantified approximately 24 and 48 hours after the removal of the patches.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50% (w/w) in arachis oil B.P.

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w) in arachis oil B.P.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

50% (w/w)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.

Results 3

Reading:

other: Control

Hours after challenge:

24

Group:

negative control

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no

Remarks on result:

other: Reading: other: Control. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.

Any other information on results incl. tables

No effects on bodyweight were observed over the test period. No adverse skin responses were noted at the 24 and 48 hour observations see Table 7.4 -1

Table 7.4-1: Number of animals exhibiting skin reactions after challenge with fluometuron

 

Group	Observation time (hours)	No. of animals	Skin responses				Severity	Incidence
			0	1	2	3
Treated	24	20	20	0	0	0	0	0/20
	48	20	20	0	0	0	0
Control	24	10	10	0	0	0	0	0/10
	48	10	10	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this study, fluometuron technical did not produce evidence of skin sensitisation. in accordance with the provisions of regulation 1272/2008, Annex I, 3.4, it is proposed classification is not required.

Executive summary:

1. A study was performed to assess the skin sensitisation potential of the test material in the albino guinea pig. The study was designed to comply with the requirements of the U.S. Environmental Protection Agency (EPA).

 

2. Twenty test and ten control animals were used for the main study. Based on the results of a sighting test, the test material was used as follows for the main study:

Topical Induction	50% (w/w) in arachis oil B.P.
Topical Challenge	50% (w/w) in arachis oil B.P.

3. The test material was found to be a non-sensitiser to guinea pig skin.