α,α,α-trifluorotoluene

Endpoint summary

Description of key information

Skin Irritation

Based on the results of an OECD 404 study the test item is not requiring classification for skin irritation (UN GHS: No Category) (reference 7.3.1-1).

Eye Irritation

Based on the results of an OECD 405 study the test item is not requiring classification for eye damaging potential (UN GHS: No Category) (reference 7.3.2-1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

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

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.

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.6 - 3.1 kg

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: washed with physiological saline
- Time after start of exposure: 24 hrs after exposure

SCORING SYSTEM:
The effects were evaluated in accordance with the Draize scheme, 1, 24, 48 and 72 hours after instillation.

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was evaluated as not irritating to the eye.

Executive summary:

The primary irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The treated eyes were rinsed gently with physiological saline solution approximately 24 hours after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

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 (reference 7.3.1-1). 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.

Eye Irritation

The primary irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits in an OECD 405 study (reference 7.3.2-1). The treated eyes were rinsed gently with physiological saline solution approximately 24 hours after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered to be classified for skin irritation and for eye damaging potential under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) No 2019/521.