5-Brom-2-[(3,4,5-trifluorphenoxy)-difluormethyl]-1,3-difluorbenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 Jun 2006 - 14 Aug 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene

EC Number:

610-623-5

Cas Number:

511540-64-0

Molecular formula:

C13 H4 Br F7 O

IUPAC Name:

5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 6-7 weeks
- Weight at study initiation: 158 - 180 g (range)
- Fasting period before study: yes, overnight (17 hours before - 4 h after treatment)
- Housing: the rats were housed in an air-conditioned room of ca. 25 m² in the Institute of Toxicology in Macrolon cages type III with a shelter, placed on mobile racks. Animals were kept on conventional softwool granulate as bedding which was changed 2x per week.
- Diet: Provimi Kliba 3433.0, ad libitum
- Water: tap water from Makrolon drinking bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
Directly before the preparation the test metariel was solved in the vehicle using a shaking device (Vortex Genie) and and Ultra Turrax device.

The vehicle chosen was Methocel(R) K4M Premium solution (Batch ZDP 24/2006 and 26/2006, stable until June 30 and July 14 2006)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The behaviour and general condition of all animals was monitored for at least 6 h after administration of the test material and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes, all surviving animals were sacrificed at the end of the experimental period by CO2 asphyxia and subjected to gross pathological investigation.

Statistics:

Body weight data were recorded with the PC software "akudat", the statistical evaluation of the body weight were carried out with the software "Tox 511A", the body weight development of each rat and group was determined. The group mean value was calculated for each measurement.

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:

There was no mortality during the study period.

Clinical signs:

other: No clinical signs were observed during the study period.

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Mortality and clinical signs during the study period

 

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males & Females
2000	0/0/6	---	---	0
LD50 > 2000 mg/kg bw

                                                                                           

* first number = number of dead animals                                 

 second number = number of animals with clinical signs         

 third number = number of animals used                               

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, it is concluded that the test item has no acute toxic potential and the the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.

Executive summary:

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw. Directly before administration the test material was prepared with aqueous Methocel Premium Solution as the vehicle. The study was performed according to OECD Guideline 423.

No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. The body weight development was inconspicuous. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Based on the results of this study, it is concluded that the test item has no acute toxic potential and the the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.