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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 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:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Guideline for the Testing of Chemicals (1987)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

Health Effects Test Guidelines (1998)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina.
- Age at study initiation: Young adults, 9-10 weeks
- Weight at study initiation: Male rats 299-315 g; female rats 209-239 g
- Housing: All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: Ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm on the dorsal skin
- % coverage: Approx. 10% of total body surface area
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 5000 mg/kg bw
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 0.9-1.2 mL deionized water used to moisten the test material and form a thick paste

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The male group and female group were dosed a week apart.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs of toxicity and dermal irritation were made daily throughout study, weighing on test day 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: The rats exhibited no clinical signs of toxicity or dermal irritation during the study.

Gross pathology:

No gross lesions were found in the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified

Executive summary:

The test material was investigated for acute dermal toxicity according to OECD Guideline 402.

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The male group and female group were dosed a week apart. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage or dysfunction at the end of the 15-day test period.

No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or biologically important body weight loss. No dermal irritation was observed. There were no gross lesions found in the study.
Under the conditions of this study, the skin absorption LD50 for the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.
Classification by the dermal route is not required based on the results of this study.