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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one

EC Number:

829-719-5

Cas Number:

1190865-44-1

Molecular formula:

C8H2Cl2F4O

IUPAC Name:

1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Not provided

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: carboxymethyl cellulose

Details on oral exposure:

VEHICLE
- Test substance was administered as solution in 1% carboxymethyl cellulose
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified

Doses:

300 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

Clinical signs and bodyweight development were monitored during the study over a period of up to 7 days.

Results and discussion

Mortality:

One animal was killed for humane reasons, approximately four hours after dosing due to the occurrence of severe clinical signs.

Clinical signs:

other: Ataxia and hunched posture were noted in all animals during the day of dosing. Ptosis and dark red stained urine was also noted in one animal and noisy respiration was also noted in one other animal.

Gross pathology:

Abnormalities noted at necropsy of the animal that was humanely killed were dark liver, dark kidneys, raised limiting ridge in the stomach, reddened non-glandular epithelium of the stomach and pale red coloured fluid filled bladder. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Any other information on results incl. tables

Table 1: Clinical signs observed during the study

Dose level mg/kg	Animal number and sex	Effects noted after dosing (hours)				Effects noted during period after dosing (days)
		0.5	1	2	4	1	2	3	4	5	6	7
300	1-0 Female	HARn	HARn	HA	HA	0	0	0	0	0	0	0
	1-1 Female	HA	HA	HA	HA	0	0	0	0	0	0	0
	1-2 Female	HA	HA	APtU	APtUX*
0 = no signs of systemic toxicity; H = Huntched posture; A = Ataxia; Pt = Ptosis; U = Dark red stained urine; Rn = Noisy respiration; X* Animal killed for humane reasons due to the occurrence of severe clinical signs of toxicity

Table 2: Bodyweight information

Dose level mg/kg	Animal number and sex	Bodyweight (g)			Bodyweight (g) at death	Bodyweight gain (g) day 0 to day 7
		Day -1	Day 0 (day of dosing)	Day 7
300	1-0 Female	158	152	161		9
	1-1 Female	167	159	167		8
	1-2 Female	166	157	-	152	-

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the results of the study, the oral LD50 of the substance in the rat was estimated to be greater than 300 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was tested on three female rats of the Wistar strain by administering a single oral dose of 300 mg/kg bodyweight in 1% carboxymethyl cellulose by gavage. The study was not conducted under GLP, but followed the basic principles of the standard acute method as laid down in EU Method B.1. Ataxia and huntched posture were observed in all animals following oral administration. Noisy respiration was also observed in one animal after dosing. One animal showed severe signs of systemic toxicity on the day of dosing, including ptosis and dark red stained urine. This animal was killed for humane reasons, approximately four hours after dosing. During necropsy a number of abnormalities were observed for this animal, including dark liver, dark kidneys, raised limiting ridge in the stomach, reddened non-glandular epithelium of the stomach and pale red coloured fluid filled bladder. No abnormalities were noted at necropsy of the other two animals that were killed at the end of the study. These two animals were also gaining bodyweights as expected. Based on the study it was estimated that the oral LD50 value for the substance in the rat was greater than 300 mg/kg bw.