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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 Mar - 29 Mar 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

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

Current version adopted in 2017

Deviations:

yes

Remarks:

number and sex of test animals; males and females were used, 5/sex

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Guideline in place during study conduct: adopted in 1987

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:

standard acute method

Limit test:

yes

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Intox PVT. Ltd., Pune, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Body weight range at study initiation: 207 - 252 g
- Housing: individually, in sterilised solid bottom polypropylene cages (sized: 35 cm (L) x 22 cm (W) x 18 cm (H)) with stainless steel grill tops and with bedding of clean and sterilised paddy husk
- 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 and UV irradiated water in drinking water quality, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- Humidity (%): 42 - 66
- Air changes (per hr): 11.03 - 11.50
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 8 Mar 2016 To: 29 Mar 2016

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Remarks:

The test substance was moistened with water.

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal skin
- % coverage: 10% of the body surface
- Type of wrap: The applied test substance was covered with a gauze patch, the latter being fixed with a gauze bandage wrapped around the animal and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was wiped off with water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw: males: 480 - 514 mg, females: 412 - 472 mg
- Constant volume used: no
- For solids, paste formed: The test substance was moistened with water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality twice a day throughout the observation period. All animals were observed for clinical signs of toxicity at 30 min, 1 h, 2 h, and 4 h after treatment on the day of treatment and once daily thereafter for 14 days. The body weights of rats were individually recorded at one day prior to treatment (Day 0), on the day of treatment (Day 1), and at weekly intervals thereafter.
- Necropsy of survivors performed: yes

Statistics:

Body weight gain and group mean values were calculated over Day 0 body weights.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

no indication of skin irritation up to the relevant limit dose level

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. No skin reaction was observed at the site of application in treated rats during this observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1. Acute dermal toxicity

Dose [mg/kg bw]	Mortality	Clinical signs
	N*	N*
Males
2000	0/5	0/5
Females
2000	0/5	0/5

*N = number of animals/number of animals used

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 dermal toxicity study in rats no mortality occured after single topical application of the limit dose level of 2000 mg/kg bw of the test substance for 24 h.
CLP: not classified