1-(3,5-Dichloro-4-fluoro-phenyl)-2,2,2-trifluoro-ethanone

Endpoint summary

Description of key information

Oral:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat according to OECD 423.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight.

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2014-05-13 to 2014-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Batch No.: CPFOA1301
Purity: 98.5%

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 152-183 g
- Fasting period before study: overnight before dosing
- Housing: housed in groups of up to three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Water: ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

DOSAGE PREPARATION (if unusual):
The test item was formulated within two hours of being applied to the test system.

CLASS METHOD
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.

Doses:

300, 2000 and 2000 mg/kg

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days.
Individual body weights were recorded prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes, at the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Hunched posture was noted during the day of dosing in two animals treated at a dose level of 300 mg/kg. There were no signs of systemic toxicity noted in one animal treated at a dose level of 300 mg/kg. Signs of systemic toxicity noted at a dose level of

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized Classification System - Category 5, >2000 - 5000 mg/kg body weight).

Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat based on OECD 423.

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at a dose level of2000 mg/kg body weight. Dosing was performed sequentially.

There were no deaths.

Hunched posture was noted during the day of dosing in two animals treated at a dose level of 300 mg/kg. There were no signs of systemic toxicity noted in one animal treated at a dose level of 300 mg/kg.

Signs of systemic toxicity noted at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, pilo-erection and diarrhea. Animals treated at a dose level of 2000 mg/kg appeared normal 1 or 2 days after dosing.

All animals showed expected gains in body weight.

No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized Classification System - Category 5, >2000 - 5000 mg/kg body weight).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

1 (reliable without restriction)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Acute toxicity:

Oral, OECD 423: LD50 > 2500 mg/kg body weight

Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should be not classified.

 

Specific target organ toxicity-single exposure:

Oral:

Clinical Observations: 

Hunched posture was noted during the day of dosing in two animals treated at a dose level of 300 mg/kg. There were no signs of systemic toxicity noted in one animal treated at a dose level of 300 mg/kg.

Signs of systemic toxicity noted at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, pilo-erection and diarrhea. Animals treated at a dose level of 2000 mg/kg appeared normal 1 or 2 days after dosing.

Body Weight: All animals showed expected gains in body weight.

Necropsy: No abnormalities were noted at necropsy.

As there were no effects considered to support classification for Category 1 and 2 observed. Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should be not classified.