2,6-difluoro-3-[(propylsulfonyl)amino]benzoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov-Dec 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: done under GLP condition and acc. to OECD guideline no. 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid

EC Number:

700-740-0

Cas Number:

1103234-56-5

Molecular formula:

C10H11F2NO4S

IUPAC Name:

2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid

Details on test material:

-Substance type: organic
-Physical state: white powder
-Storage condition of test material: at room temerature, protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Laboratories France, L'Arbresle Cedex, France
-Age at study initiation: 11 weeks (male)
15-17 weeks (females)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped with electric clippers

Vehicle:

other: PEG 300

Controls:

no

Amount / concentration applied:

0.5 g of test substance moistened with 0.5 mL PEG 300 and applied to the skin

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Test Item Administration
The test item was administered at 0.5 g/animal, the dose specified in the test guidelines for a
solid test item.
Four days before treatment, the left flank was clipped with an electric clipper, exposing an area
of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day
before treatment, and regrown fur of all animals was clipped again.
Animals with overt signs of skin injury or marked irritation which may have interfered with the
interpretation of the results were not used in the test.
On the day oftreatment, 0.5 g ofSAC-Sulfonamidsaure moistened with 0.5 mL
PEG 300 was placed on a surgical gauze patch (ea. 2.5 cm x 2.5 cm) held in contact with the skin
by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer
bandage wrapped around the abdomen.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed
with lukewarm tap water to clean the application site.
As it was suspected that the test item might produce irritancy, a single animal (one female) was
treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-
hour exposure, the test was completed using the two remaining animals for an exposure period of
four hours.
Rationale: The application form and dose were used to detect a possible irritating potential of the
test item applied.

Observations
Viability I Mortality:
Clinical Signs (systemic):
Body Weights:
Skin Reactions:

No necropsy was performed on the animals sacrificed at termination of observation.
All rabbits were sacrificed by an intravenous injection of pentobarbitone into the ear vein at a
dose of at least 1 mL/kg body weight and discarded.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1,24,48 and 72 hours

Score:

0

Irritant / corrosive response data:

none

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these results SAC-Sulfonamidsäure does not have to be classified and has no obligatory labelling requirements for skin irritation acc to the : GHS and EU CLP regulations

Executive summary:

The primary skin irritation potential of SAC-Sulfonamidsaure was investigated according to OECD test guideline No. 404 and Commission Regulation (EC) No. 440/2008. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), SAC-Sulfonamidsaure is not classified with respect to skin irritation.