3'-(trifluoromethyl)acetophenone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3'-(trifluoromethyl)acetophenone

EC Number:

206-490-4

EC Name:

3'-(trifluoromethyl)acetophenone

Cas Number:

349-76-8

Molecular formula:

C9H7F3O

IUPAC Name:

1-[3-(trifluoromethyl)phenyl]ethan-1-one

Test material form:

liquid

Specific details on test material used for the study:

- Stability under test conditions: no information available
- Solubility and stability of the test substance in the solvent/vehicle: no information available
- Treatment of test material prior to testing: no information available
- Final dilution of a dissolved solid, stock liquid or gel: 5999 mg test article with vehicle ad 30 ml (no further information (e.g. on correction factor) available

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 7-11 weeks
- Weight at study initiation: approx. 154-191 g
- Housing: Macrolon Type 4 cages; 5 same-sex animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): ca. 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5999 mg test article with vehicle ad 30 ml
- Volume applied: 10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment.

Gross pathology:

Necropsy examinations revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Groups of 5 male and 5 female rats were administered a single dose of the formulated test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 2000 mg/kg body weight.