α,α,α-trifluorotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

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:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluorotoluene

EC Number:

202-635-0

EC Name:

α,α,α-trifluorotoluene

Cas Number:

98-08-8

Molecular formula:

C7H5F3

IUPAC Name:

α,α,α-trifluorotoluene

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.8 - 3.1 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Amount / concentration applied:

- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

2 weeks

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Skin of back and sides.

SCORING SYSTEM:
The findings at test sites were evaluated 30 and 60 min after the end of exposure and after 24, 48 and 72 hours. The findings were expressed numerically in accordance with the Draize scheme.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

other: eschar score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Irritant / corrosive response data:

Areas of very mild edema and mild to moderate erythema were observed in all rabbits up to 72 hours after application. While the erythema and edema had almost completely disappeared by the end of the observation period, the skin surface remained dry and rough, and was parchment-like and flaky in parts. Scab formation was seen in 1 animal after 7 days. The average irritation value was 2.0 for erythema and eschar formation and 0.2 for edema formation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered to be not irritating to rabbit skin.

Executive summary:

The primary skin irritation potential of the test item was investigated by topical application of 0.5 mL to skin of the back and sides of each of three young adult New Zealand White rabbits in an OECD 404 study. The duration of treatment was four hours. The scoring of skin reactions was performed 0.5, 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. Areas of very mild edema and mild to moderate erythema were observed in all rabbits up to 72 hours after application. While the erythema and edema had almost completely disappeared by the end of the observation period, the skin surface remained dry and rough, and was parchment-like and flaky in parts. Scab formation was seen in 1 animal after 7 days. The average irritation value was 2.0 for erythema and eschar formation and 0.2 for edema formation. The test item was accordingly assessed as a mild skin irritant in rabbits. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the above results, the test item is considered to be not irritating to rabbit skin.