Chlorimuron ethyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate

EC Number:

618-690-2

Cas Number:

90982-32-4

Molecular formula:

C15H15ClN4O6S

IUPAC Name:

ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate

Test material form:

solid

Remarks:

White

Details on test material:

95 to >99% purity

Specific details on test material used for the study:

Substance type: White powder; Analytical purity: 97.4%; Lot/batch # JUL05MA037;
Stability under test conditions: The test substance was expected to be stable for the duration of testing;
Storage conditions of the test material: Stored at room temperature; pH 6 in a 1% aqueous solution

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test animals: Source: Robinson Services, Inc. Clemmons, NC;
Age at study initiation: not stated;
Weight at study initiation: 1992-2120 g
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors;
Acclimation period: 6 days;
Environmental conditions: Temperature and Relative Humidity Ranges: 20-22°C and 25-38%, respectively; Photoperiod: 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

Five-tenths of a gram of the test substance (0.83g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site on each animal.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al. immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No irritation

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No irritation

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No irritation

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Not irritating

Other effects:

All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the United Nations Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.

Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application (OECD 404). At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al. immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above.

 

There was no dermal irritation observed at any treated dose site during the study. All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed.