3'-(trifluoromethyl)acetophenone

Endpoint summary

Description of key information

Skin irritation/corrosion:

A dermal irritation/corrosion test according to OECD TG 404 was conducted with test article. The test article (0.5 ml) was applied to the shaved skin of three male rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48, and 72 hours after patch removal. Very slight erythema was observed in all animals at the 1-hour and 24-hour examination. At the 48-hour examination, very slight erythema was still detectable in two animals. All skin reactions were fully reversed within 72 hours after patch removal. There was no mortality, and there were no remarkable clinical observations. Body weights were not affected by treatment.

Eye irritation:

An eye irritation/corrosion test was conducted with test article according to OECD TG 405. The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment. Redness of the conjunctiva was observed in all animals at the 1-hour reading. All eye reactions were clear by day 1 after treatment. There was no mortality, and no remarkable clinical observations. Body weights were not affected by treatment.

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:

June 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: ca. 2-3 months
- Weight at study initiation: approx. 2870-3000 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

72 h (sufficient to determine reversibility)

Number of animals:

3 males

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Very slight erythema was observed in all animals at the 1-hour and 24-hour examination. At the 48-hour examination, very slight erythema was still detectable in two animals. All skin reactions were fully reversed within 72 hours after patch removal.

There was no mortality in the test.

There were no remarkable clinical observations.

Body weights were not affected by treatment.

Interpretation of results:

GHS criteria not met

Executive summary:

A dermal irritation/corrosion test according to OECD TG 404 was conducted with test article. The test article (0.5 ml) was applied to the shaved skin of three male rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48, and 72 hours after patch removal. Very slight erythema was observed in all animals at the 1-hour and 24-hour examination. At the 48-hour examination, very slight erythema was still detectable in two animals. All skin reactions were fully reversed within 72 hours after patch removal. There was no mortality, and there were no remarkable clinical observations.

Body weights were not affected by treatment.

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:

June - July 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: ca. 2-4 months
- Weight at study initiation: approx. 2750-3240 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye remained untreated and served as a control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

app. 24 h

Observation period (in vivo):

3 days (sufficient to determine reversibility of effects).

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with distilled water for 1 minutes
- Time after start of exposure: after the reading at 24 hours post-treatment

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Hyperaemic conjunctival blood vessels (score of 1) were observed in all rabbits at the 1 -hour reading. All eye reactions were clear by day 1 after treatment.

There was no mortality in the test.

There were no remarkable clinical observations.

Body weights were not affected by treatment

Interpretation of results:

GHS criteria not met

Executive summary:

An eye irritation/corrosion test was conducted with test article according to OECD TG 405. The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment. Redness of the conjunctiva was observed in all animals at the 1-hour reading. All eye reactions were clear by day 1 after treatment. There was no mortality, and no remarkable clinical observations. Body weights were not affected by treatment.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study results for skin and eye irritation no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.