3'-(trifluoromethyl)acetophenone

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Study period:

July - September 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.2 (Acute Toxicity (Inhalation))

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1981

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

1996 ("Public Draft")

GLP compliance:

yes (incl. QA statement)

Test type:

fixed concentration procedure

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: Considered to be stable
- Preparation of test articel: The test article was used as supplied by the Sponsor. The test aerosol was generated in ambient conditions using a nebuliser connected to a syringe pump.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-10 weeks
- Weight at study initiation: approx. 193-227 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 +/- 1
- Humidity (%): between 50 -80
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Remarks:

flow-past exposure

Vehicle:

air

Remark on MMAD/GSD:

Attempts to measure particle size during the exposure produced faulty and unrepresentative results, because of evaporation of the test article, and consequently condensation inside the impactor used for measuring particle size. Therefore particle size data and a mean mass aerodynamic diameter (MMAD) were not reported.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

target concentration 5 mg/l air
Achieved concentrations:
- Nominal: 9.217 mg/l air
- Gravimetric: 5.287 mg/l air
- Analytical: 6.913 mg/l air

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

The LOGIT-Model was not used as only one group was exposed and there were no deaths.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.913 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: analytical mean value

Remarks:

with a standard deviation of +- 0.472 mg/l air

Mortality:

no deaths occured

Clinical signs:

other: The principal clinical signs observed were the findings of ruffled fur, decreased spontaneous activity and uncoordinated movements/gait. From the nature and severity of these clinical signs, systemic exposure of the animals to the test article was conclud

Body weight:

Body weights were not affected in male animals. A slight, transient retardation in mean body weight gain of female animals from test day 1 (prior to exposure) to test day 4 may have been treatment-related.

Gross pathology:

There were no macroscopical pathology findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC 50 of the test item was estimated to be greater than 6.913 mg/l air (analytical mean value), as no deaths occured.

Executive summary:

Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings.