2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

475207-59-1

Cas Number:

475207-59-1

IUPAC Name:

475207-59-1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: not specified
- Mean weight at study initiation: 193-211 g (males) or 180-195 g (females)
- Housing: in groups of 5 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): approx. 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: test item was suspended in 15 % Pluronic F68 (42.5 % propylene glycol and 42.5 % polyethylene glycol 400)

Details on oral exposure:

- Application volume: 10 mL/kg bw

Doses:

500 and 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died after administration of 500 or 2000 mg/kg bw.

Clinical signs:

other: After administration of 500 and 2000 mg/kg bw soft feces were observed in all animals up to day 3 of the observation period.

Gross pathology:

No gross pathological findings were observed.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test item BAY 54-9085 was low with an LD50 exceeding 2000 mg/kg bw in rats according to OECD TG 401. A single oral administration of the test substance by gavage to male and female rats in doses up to 2000 mg/kg bw was tolerated without mortalities, effects on body weight gain or gross pathological findings.

Executive summary:

In an acute oral toxicity study according to OECD Guideline 401, groups of fasted Wistar rats (5/sex) were given a single oral dose of BAY 54-9085 in 15 % Pluronic F68 (42.5 % propylene glycol and 42.5 % polyethylene glycol 400) at doses of 500, or 2000 mg/kg bw and observed for 14 days.

A single oral administration of the test substance by gavage to male and female rats in doses up to 2000 mg/kg bw was tolerated without mortalities, effects on body weight gain or gross pathological findings. The LD50 was >2000 mg/kg bw for males and females.