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Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
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