4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 August 2019 to 7 October 2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

EC Number:

850-929-8

Cas Number:

1584-79-8

Molecular formula:

C15H13F3N2O3S

IUPAC Name:

4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

Test material form:

solid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
Number: 12
Age at study initiation: 7 weeks
Weight at study initiation:
1st step: 196.8g to 202.5 g
2nd step: 202.7-204.4 g
3rd step: 207.4 to 216.7
4th step: 195.2-212.9 g
Six days of quarantine/acclimatization in groups of 3 animals per cage.
After Quarantine, the animals were acclimatized under group housing of three of fewer animals per cage until group allocation. The animas were housed in a barrier system animal rooms
pellet diet: ad libitum
water: ad libitum

ENVIRONMENTAL CONDITIONS
Temperature: 21-25 °C
Rel. Hum. 40-79%
Air change per hour: 15
Photoperiod of 12 hours light per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Rationale for the selection of the starting dose: In absence of data regarding the toxicity of the test item, 300 mg/kg bw was chosen as starting point.

Doses:

1st/2nd step: 300mg/kg; 10 mL/kg
3rd/4th step: 2000 mg/kg, 10 mL/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The animals were fasted for 17-19 hours before the administration, and for three to four hours after the administration. The administration was performed once by gavage. The administration was conducted with a syringe at the volume of 10 mL/kg based on the body weight measured on the administration day.
Duration of the observation period following administration: 14 days.
Frequency of observations and weighing: body weights were recorded on days 0 (before administration) , 7, 14, or at death, clinical signs; 10 mins, 30 mins, 1 hour, 2 hours, 3 hours, 4 hours, and 5 hours after dosing, once daily thereafter.
Necropsy of survived animals was done after 14 days, of dead animals immediately after dead. External surface of the body, all orifices, subcutis, cranial, thoracic, abdominal, and pelvic cavities with their contents were observed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 500 mg/kg bw

Based on:

test mat.

Mortality:

1

Clinical signs:

other: Adverse effects on the digestive tract and nervous system was observed. Mucous stool was observed at 300 and 2000 mg/kg. It was considered as adverse effects on the digestive tract. The effects had good reversibility.

Gross pathology:

In the general clinical observation, salivation, restlessness, lacrimation, decreased spontaneous locomotion, decreased respiratory rate and incomplete eyelid opening were observed mainly at 2000 mg/kg. Salivation and restlessness were considered to be caused not by irritation of the test substance but by adverse effects on the nervous system, since no findings associated with the irritability was observed in the necropsy of the dead animal. Lacrimation might be caused by the adverse effects on the nervous system. Decreased spontaneous locomotion, decreased respiratory rate and incomplete eyelid opening were caused by the adverse effects on the digestive tract and/or nervous system. Since these toxic symptoms disappeared by one day after the administration except for the dead animal, and since the body weight increase was normal seven days after the administration, the adverse effects had good reversibility.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The hazard class of the acute oral toxicity of the substance was classified to Category 5 since no mortality or moribundity occurred in any animals of the 1st or 2nd step at 300 mg/kg or 4th step at 2000 mg/kg, but one animal was dead in the 3rd step at 2000 mg/kg.

Executive summary:

The hazard class of the acute oral toxicity of the substance was classified to Category 5 since no mortality or moribundity occurred in any animals of the 1st or 2nd step at 300 mg/kg or 4th step at 2000 mg/kg, but one animal was dead in the 3rd step at 2000 mg/kg.

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