Benzoic acid, 2-fluoro-5-(methylsulfonyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2010-November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-fluoro-5-methanesulfonylbenzoic acid

EC Number:

689-137-0

Cas Number:

247569-56-8

Molecular formula:

C8 H7 F O4 S

IUPAC Name:

2-fluoro-5-methanesulfonylbenzoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Description : white solid
Batch number : BS11020465
Purity : 99.5%
Date received : 18 June 2012
Expiry date : 21 May 2013
Storage conditions : room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Duration of treatment / exposure:

One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 g of the test item,
moistened sufficiently with 0.5 ml of distilled water to achieve a paste, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was
secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped
in an elasticated corset for the duration of the exposure period.

One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.
Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.

After consideration of the skin reactions produced in the first animal, an additional two animals were treated with 0.5 g of test item, moistened sufficiently with 0.5 ml of distilled water to achieve a paste. One patch was applied to the back of each rabbit and was allowed to remain in contact with the skin for a
period of four hours.

Observation period:

Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Number of animals:

One rabbit was initially treated and then an additional 2 animals were treated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 7 days

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 7 days

Score:

0

Other effects:

Bodyweight :
all animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.

Executive summary:

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

The method was designed to be compatible with the following:

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

• Method 84 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.