(1-[2-[5-METHYL-3-(TRIFLUOROMETHYL)-1H-PYRAZOL-1-YL]ACETYL]-4-HETEROMONOCYCLECARBOTHIOAMIDE)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

Purity: 92.1%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 171-177 g
- Fasting period before study: fasted overnight
- Housing: The animals were individually housed in plastic solid bottom polycarbonate cages
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting.
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 6 or 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 30-67%
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: administered as a 45% w/w mixture in a 0.5% w/v aqueous solution of methylcellulose

Details on oral exposure:

The test substance was administered as a 45% w/w mixture in a 0.5% w/v aqueous solution of methylcellulose.

Doses:

5000 mg/kg

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
-Frequency of weighing: Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Apart from one female exhibiting reduced faecal volume on Day 1, there were no other signs of gross toxicity or abnormal behaviour.

Body weight:

All animals survived test substance administration and gained body weight during the study.

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 >5000 mg/kg

Executive summary:

An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for the test substance to produce toxicity from a single dose via the oral route. An initial limit dose of 5000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously. Since these animals survived, no additional animals were tested. All animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days after dosing.

All animals survived test substance administration and gained body weight during the study. Apart from one female exhibiting reduced faecal volume on Day 1, there were no other signs of gross toxicity or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the acute oral LD₅₀ of the test substance is greater than 5000 mg/kg of body weight in female rats.