4-chloro-α,α,α-trifluorotoluene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline FEDERAL REGISTER vol. 38 n. 187, s.27019/1973

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-α,α,α-trifluorotoluene

EC Number:

202-681-1

EC Name:

4-chloro-α,α,α-trifluorotoluene

Cas Number:

98-56-6

Molecular formula:

C7H4ClF3

IUPAC Name:

1-chloro-4-(trifluoromethyl)benzene

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Parachlorbenzotrifluorid
- Physical state: colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1,5 -2,0 kg
- Housing: individually caged
- Diet: ERKA 8300 ad libitum
- Water: ad libitum


IN-LIFE DATES: From: 3 February To: 7 February

Test system

Vehicle:

other: sesame oil

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL undiluted

Duration of treatment / exposure:

24 hs

Observation period (in vivo):

Up to 72 hs

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological solution
- Time after start of exposure: 24 hs

SCORING SYSTEM: According to FDA Classification , 1959 s.51, reported in the Table below.

TOOL USED TO ASSESS SCORE: fluorescein in dilution 0.01 %, instilled after 48 and 72 hs.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Time point:

24/48/72 h

Remarks on result:

other: not reported

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The test item results not irritant to the rabbit eye.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The test item results not irritating to the rabbit eye.

Executive summary:

The test item was instilled into the right eye of 6 rabbits, while the left eye served as control. 0.1 mL of undiluted product was instilled in the eye and washed after 72 hs. The observation period was up to 72 hs. Fluorescein was instilled after 48 hours and 72 hours to assess the scores. The irritation index was calculated based on effects on cornea, iris and conjunctiva after 1, 7, 24, 48 and 72 hours. The maximum score was 2 and it was observed after 7 hours. The effect was fully reversible after 24 hours. Therefore, the product is classified as not irritant to eyes.