1-(3-Chloro-2-pyridinyl)-4,5-dihydro-3-[(phenylsulphonyl)oxy]-1H-pyrazole-5-carboxylic acid ethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 2006 - October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Methods for the Determination of Toxicity (1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Guideline for the Testing of Chemicals (2002)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

Health Effects Test Guidelines (1998)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 3-[(benzenesulfonyl)oxy]-1-(3-chloropyridin-2-yl)-4,5-dihydro-1H-pyrazole-5-carboxylate

EC Number:

846-153-4

Cas Number:

653592-41-7

Molecular formula:

C17H16ClN3O5S

IUPAC Name:

ethyl 3-[(benzenesulfonyl)oxy]-1-(3-chloropyridin-2-yl)-4,5-dihydro-1H-pyrazole-5-carboxylate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Kalamazoo, Michigan
- Age at study initiation: Young adult
- Weight at study initiation: 2722-3352 g
- Housing: Animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet: PMI Nutrition International, LLC Certified Rodent LabDiet (#5322), approximately 125 g daily
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16–22
- Humidity (%): 30–70
- Air changes (per hr): Not recorded
- Photoperiod (hrs dark / hrs light): Alternating 12-hour light and dark cycles

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

other: The adjacent areas of untreated skin served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g test substance moistened with approximately 0.4 mL of deionized water

Duration of treatment / exposure:

4 hours

Observation period:

4 days
Reading time points: 1, 24, 48 and 72 h
The rabbit treated initially was also evaluated immediately after test substance removal

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: Lumbar region of back, 6 cm²
- Type of wrap if used: The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were washed with warm water to remove excess test substance
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS: 1, 24, 48, 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

1/3 females showed very slight erythema 1 h after removal of the dressings. The effect was fully reversible within 24 h. No other skin reactions were observed.

Any other information on results incl. tables

Table 1: Dermal irritation scores according to Draize (1959)

Animal	No.	Parameter	0 h	1 h	24 h	48 h	72 h	Mean 24/48/72 h
1	256	Eryhtema Oedema	0 0	0 0	0 0	0 0	0 0	0 0
2	269	Eryhtema Oedema	- -	0 0	0 0	0 0	0 0	0 0
3	270	Eryhtema Oedema	- -	1 0	0 0	0 0	0 0	0 0

 

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified

Executive summary:

The test substance was investigated in a an Acute Dermal Irritation Study in Rabbits according to OECD Guideline 404.

The test substance was applied as a single 0.5-g dermal dose to the shaved intact skin of 3 female rabbits. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated by Draize (1959) for signs of dermal irritation 1, 24, 48, and 72 hours after test substance removal. The rabbit treated initially was also evaluated immediately after test substance removal.
Erythema (score of 1) was observed in one rabbit only at the 1 hour observation. No dermal irritation was observed in the remaining two rabbits. Based on the mean degree of skin reaction observed at 24 to 72 hours, and according to the provisions of Regulation (EC) No 1272/2008, classification is not required.