2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 16 2002 - April 19 2002.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

EC Number:

264-980-3

EC Name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Cas Number:

64628-44-0

Molecular formula:

C15H10ClF3N2O3

IUPAC Name:

3-(2-chlorobenzoyl)-1-[4-(trifluoromethoxy)phenyl]urea

Test material form:

solid: particulate/powder

Remarks:

White powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Age: Young adult.

Source: Received from Davidson’s Mill Farm, South Brunswick, NJ on April 4, 2002.

Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.

Animal Room Temperature Range: 19-23°C

Photoperiod: 12 hour light/dark cycle

Acclimation Period: 12 days

Food: Pelleted Purina Rabbit Chow #5326

Water: Filtered tap water was supplied ad-libitum by automatic water dispensing system.

Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Five-tenths of a gram of the test substance (0.71 g of the test mixture) was placed on a 1 inch x 1 inch, 4-ply gauze pad and applied to one 6 cm^2 intact dose site on each animal.

Duration of treatment / exposure:

4 hours.

Number of animals:

3 rabbits (2 females, 1 male).

Details on study design:

Preparation and Selection of Animals:
On the day before application, a group of animals was prepared by clipping (Oster model #A5-small) the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Only healthy animals without preexisting skin irritation were selected for the test.

Application of Test Substance:
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 70% w/w mixture. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 inch Micropore tape, to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit, and they were returned to their designated cages. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites gently wiped with water and a clean towel to remove any residual test substance.

Evaluation of Test Sites:
Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48 and 72 hours after patch removal. The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72 hour scoring intervals and dividing by the number of evaluation intervals (4). The resulting Primary Dermal Irritation Index (PDII) was classified as follows: 0, Non-irritating, > 0 - 2.0, Slightly irritating, 2.1 - 5.0 Moderately irritating, > 5.0 Severely irritating.

Cage-Side Observations:
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Edema

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Erythema

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Triflumuron was found to be non-irritant under the conditions of this study and does not require classification for skin corrosion or irritation according to the CLP criteria.

Executive summary:

Triflumuron (0.5 g) was applied to the shorn intact skin of 3 rabbits using a 70% (w/w) mixture (test substance/distilled water). The contact period was 4 hours; dermal reactions were scored for up to 72 hours.  No signs of dermal irritation were seen in any rabbit at any time point. Triflumuron was therefore found to be non-irritant under the conditions of this study and does not require classification for skin corrosion or irritation according to the CLP criteria.