5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Mar - 12 Apr 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted in 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

446-630-3

EC Name:

-

Cas Number:

181587-01-9

Molecular formula:

C13H9Cl2F3N4OS

IUPAC Name:

5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethanesulfinyl)-1H-pyrazole-3-carbonitrile

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Intox PVT. Ltd.
- Females nulliparous and non-pregnant: yes
- Age at start of treatment: 8 weeks
- Body weight at start of treatment: 145 - 155 g (females)
- Fasting period before study: Yes, rats were fasted overnight prior to dosing. Food was offered 3 - 4 h after dosing.
- Housing: group housing, 3 animals of the same dose group in one cage (cage size: 35 cm (L) x 22 cm (W) x 18 cm (H)), in sterilized solid bottom polypropylene cages with stainless steel grill tops and sterilized paddy husk bedding
- Diet: extruded pelleted rat feed Altromin (manufactured by M/s Altromin Spezialfutter GmbH & Co. KG, Germany, and supplied by ATNT Laboratories, Mumbai, India), ad libitum
- Water: filtered water of drinking water quality, ad libitum
- Acclimation period: 7 - 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 38 - 66
- Air changes (per hr): 11.03 - 14.6
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 Mar 2016 To: 12 Apr 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: analytical grade water with 0.2% Tween 80

Details on oral exposure:

VEHICLE
- Test substance concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: Formulations of the test substance were prepared freshly before dosing on each day. The test substance was suspended in analytical grade water with 0.2% Tween 80 as a wetting agent.

CLASS METHOD
- Rationale for the selection of the starting dose: A previous acute toxicity study revealed that the oral LD50 value in male and female rats is >7080 mg/kg bw. Based on the available information, the present study was started at the dose level of 2000 mg/kg bw, according to OECD TG 423.

Doses:

2000 mg/kg bw (step 1 and step 2)

No. of animals per sex per dose:

3 female animals per group; two groups were tested stepwise in 2 consecutively steps (referred as step 1 and step 2)

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality twice a day throughout the observation period. Following test substance administration, animals were observed for clinical signs of toxicity 10 min, 30 min, 1 h, 2 h and 4 h post dosing and periodically thereafter for the first 24 h post dosing. During the 14-day observation period, animals were observed at least once a day. Body weight was measured at one day prior to dosing (Day 0), on the day of dosing (Day 1, fasting body weight), on Day 7 and at study termination on Day 15.
- Necropsy of survivors performed: yes

Statistics:

Body weight gain and group mean values were calculated.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1. Acute oral toxicity

 

Dose [mg/kg bw]	Mortality	Clinical signs
	N*	N*
Females
2000	0/6	0/6

*N = number of animals/ number of animals used (shown as combined values from step 1 and step 2)

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

In the present acute oral toxicity study in rats no mortality (0/6 rats) occured after single gavage of 2000 mg/kg bw of the test substance.
CLP: not classified