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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
Guideline for the Testing of Chemicals (2001)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
Health Effects Test Guidelines (2002)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
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: 10-11 weeks
- Weight at study initiation: 226-238 g
- Fasting period before study: 16-18.5 hours prior to dosing
- 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
- 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

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Dose suspended in 0.5% aqueous methylcellulose
- Amount of vehicle: 10 mL per kg of body weight
Doses:
175 mg/kg
550 mg/kg
1750 mg/kg
5000 mg/kg
No. of animals per sex per dose:
175 mg/kg - 1 female rat
550 mg/kg - 1 female rat
1750 mg/kg - 1 female rat
5000 mg/kg - 3 female rats
Control animals:
no
Details on study design:
A single oral dose of the test substance suspended in 0.5% aqueous methylcellulose, was administered by oral gavage to one fasted female rat each at a dose of 175, 550, or 1750 mg/kg and to three fasted female rats at a dose of 5000 mg/kg. The rats were dosed one at a time at a minimum of 48-hour intervals.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for clinical signs at the beginning of fasting, just before dosing (test day 0), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter. The rats were weighed on test days –1, 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
A software package (A0T425StatPgm), prepared for U.S. EPA by Westat, May 2001, was used to determine the dose progression and to calculate the LD50.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: The rat dosed at 550 mg/kg exhibited high carriage and ataxia on the day of dosing. No clinical signs were observed in the remaining rats.
Gross pathology:
No gross lesions were found in the study

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: no classification
Executive summary:

The acute oral toxicity of the test item was investigated according to OECD Guideline 425.


A single dose of the test substance was administered by oral gavage to one fasted female rat each at a dose of 175, 550, or 1750 mg/kg and to three fasted female rats at a dose of 5000 mg/kg. The rats were dosed one at a time at a minimum of 48-hour intervals. The rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage or dysfunction.


No deaths occurred. The rat dosed at 550 mg/kg exhibited high carriage and ataxia on the day of dosing. No clinical signs were observed in the remaining rats. The rats exhibited no body weight losses after dosing. No gross lesions were found in the study.
Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.