3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HanRcc:WIST(SPF) rats were supplied by RCC Ltd Laboratory Animal Services, Woelferstrasse 4, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 8 – 12 weeks
- Weight at study initiation: ca. 185 g
- Fasting period before study: at least 16 hours before administration, but water was available ad libitum
- Housing: Single housing in Makrolon cages, type III
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% CMC solution in double distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females in two trials

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 0/6 animals died; clinical signs were reversible on the day of application

Mortality:

0/6 animals died

Clinical signs:

other: Clinical observation revealed impaired general state, dyspnoea and piloerection and were observed from hour 1 through to hour 5 after administration.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (6 females) examined on the last day of observation.