N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Jan 1988 to 08 Feb 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Feb 1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide

EC Number:

410-690-9

EC Name:

N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide

Cas Number:

103055-07-8

Molecular formula:

C17 H8 Cl2 F8 N2 O3

IUPAC Name:

1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 - 8 weeks young adults
- Weight at study initiation: 169 - 204 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: housed in Macrolon cages type 4, with standardized soft wood, segregated by sex, group-housed (5 animals per cage)
- Diet: Rat chow, ad libitum
- Water: provided, ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Jan 1988 To: 08 Feb 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

The test substance was administered at a single dose volume of 10 mL/kg bw.

Doses:

2000 mg/kg bw

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 clinical signs: The animals were observed for signs of systemic toxicity twice (a.m. and p.m.) on working days, and once (a.m.) on weekend days
- The animals were weighed at the start and on day 7 and 14.
- The animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: Ruffled fur, dyspnea, hunched posture, and exophthalmos were seen, being common symptoms in acute tests. The animals recovered within 11 days.

Gross pathology:

No deviations from normal morphology were found.

Any other information on results incl. tables

Table 1 Mean body weight and standard deviation

	males			females
Dose (mg/kg)	Day 1	Day 7	Day 14	Day 1	Day 7	Day 14
2000	191/9.0	269/11.2	313/13.8	176/5.5	226/7.7	249/12.8

Table 2: Signs and symptoms

Observations

Exposure day (hours)

Days of post-exposure period

1

2

3

4

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

2000 mg/kg males

ruffled fur

x

xx

xx

x

x

x

x

x

x

x

x

x

x

x

x

dyspnea

xx

x

x

x

x

x

x

x

x

x

x

body position curved

x

x

x

x

x

x

x

exophtalmos

x

x

x

x

x

x

x

x

x

x

2000 mg/kg females

ruffled fur

x

xx

xx

x

x

x

x

x

x

x

x

x

x

x

x

dyspnea

xx

x

x

x

x

x

x

x

x

x

x

body position curved

x

x

x

x

x

x

x

exophtalmos

x

x

x

x

x

x

x

x

x

x

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test substance is estimated to be > 2000 mg/kg for both male and female rats.

Executive summary:

Groups of 5 young adult male and 5 female Tif: RAI f (SPF) rats received a single oral (gavage) dose of 2000 mg/kg bw of the test substance in a study performed according to OECD TG 401 following GLP principles. Prior to dosing, the animals were fasted overnight. The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their body weights were recorded at intervals throughout the study. All animals were subjected to a complete gross necropsy following their sacrifice or spontaneous death. Ruffled fur, dyspnoea, hunched posture, and exophthalmos were observed, being common symptoms in acute tests. The animals recovered within 11 days. Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined for the test substance. The LD50 in both male and female rats was greater than 2000 mg/kg bw.