4-(trifluoromethoxy)aniline

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June to October 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

first version adopted 1981

Deviations:

yes

Remarks:

Experimental procedures are only briefly described

GLP compliance:

no

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(trifluoromethoxy)aniline

EC Number:

207-317-5

EC Name:

4-(trifluoromethoxy)aniline

Cas Number:

461-82-5

Molecular formula:

C7H6F3NO

IUPAC Name:

4-(trifluoromethoxy)aniline

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen), Germany
- Weight at study initiation: 160-220 g
- Fasting period before study: 16 hours
- Housing: Makrolon cages, type III
- Diet: Altromin-R-haltungsdiät

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 1-3 L per minute of air was passed through the substance in a sintered wash bottle. The air enriched with the test material vapors was diluted with 0-9 L air per minute and then passed into the dynamic inhalation apparatus according to Kimmerele and Eben, 1973.
- Exposure chamber: not specified; however, it was mentioned in the study report that the exposure conditions were as such as to ensure vapor inhalation and avoid skin contact with the test material.

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: not reported
- Samples taken from breathing zone: not specified
- Time needed for equilibrium of exposure concentration before animal exposure : not specified

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.241, 0.519, 0.860, 0.950, and 1.185 mg/L air for males and females

No. of animals per sex per dose:

10 males and 10 females per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: up to 21 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Clinical signs of toxicity were observed and reported.

Statistics:

Not applied

Results and discussion

Preliminary study:

Preliminary test not conducted

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

1.1 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

0.9 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

For males, mortality occurred at doses of greater than or equal to 0.950 mg/L air. At these dose levels, 3/10 and 7/10 males died at 0.950 and 1.185 mg/L air, respectively. For females, mortality occurred at doses of greater than or equal to 0.860 mg/L air. At these dose levels, 1/10, 9/10, and 8/10 females died at 0.860, 0.950, 1.185 mg/L air, respectively.

Clinical signs:

other: apathy, ungroomed fur, piloerection, staggering, later sedation, lying on the side, prostrated,transient bluish coloration of the skin (5 days), behavioral and respiratory disorders up to 16 days following treatment.

Body weight:

Not reported

Gross pathology:

The following findings were made on necropsy for those rats that died during treatment: dark-brown mottled lungs; emphysema; mottled liver; pale discolored spleen; reddish slime in the small intestines; pale discoloration of the kidneys; and fluid in the thoracic cavity.

Slight emphysema of the lungs was observed at the end of the observation period following necropsy of the rats which survived concentrations of greater than or equal to 0.95 mg/L air. Some cases of pale-pink colored lungs with slight emphysematous changes were also observed amongst the remaining surviving rats at the end of the observation period at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

In a study conducted in a similar method to OECD 403, the LC50 values for male and female rats following exposure to the test material as a vapour for 4 hours were approximately 0.9 mg/L air and 1.1 mg/L air, respectively. Thus, the LC50 values were in the range of > 0.5 to ≤ 2 mg/L air.