Ethanone, 1-(3-methyl-2-benzofuranyl)-

Endpoint summary

Description of key information

In a skin irritation study in rabbits according to OECD guideline 404, the test item was found to be not irritating to the skin.

 

In an eye irritation study according to OECD guideline 405, the test item was found to be not irritating to the rabbit's eye.

 

Conclusion: The test item was not skin or eye irritating in vivo.

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:

1997-02-24 to 1997-02-28

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:

1992-12-29

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: The rabbits were caged individually in PPO/HIPS Noryl®) cages (floor area: 2576 cm^2) with perforated floor. The trays under the cages were cleaned 2-3 times a week.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

not specified

Preparation of test site:

clipped

Vehicle:

other: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 100%, 25%, 10%, 5% and 1%

VEHICLE
- Amount applied: 0.5 mL
- Concentration: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w)

Duration of treatment / exposure:

4 hours

Observation period:

From the beginning of treatment until 72 hours after treatment

Number of animals:

4 rabbits, each was treated with 6 different concentrations of the test item

Details on study design:

TEST SITE
- Area of exposure: An area of 10 x 10 cm was clipped and divided into 6 test sites. Each test site was covered with a 2.5 x 2.5 cm gauze patch.
- % coverage: Not specified
- Type of wrap: The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, the treated skin was cleaned with lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
The skin reactions were read 1 hour after the end of treatment. Reading was also made 24, 48 and 72 hours after termination of exposure.

SCORING SYSTEM
- Method of calculation: The scores for erythema and oedema formation for the last 3 readings at 24, 48 and 72 hours for each rabbit were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation for the individual rabbits for each test concentration. The scoring system is described under "Any other information on materials and methods, incl. tables", table 1.

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Remarks:

The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

probability of weak irritation

Remarks:

The results are given for a 100 % test concentration. A test concentration of 25% showed an erythema score of 0.33 and 10%, 5% and 1% test concentrations showed a score of 0.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to be not irritating to the skin.

Executive summary:

The primary skin irritant effect of the test item was investigated in a GLP-compliant study according to the method recommended in OECD Guideline 404. The study was extended to investigate five different concentrations of the test article and a vehicle control on each animal. Four rabbits were exposed to different concentrations of the test article at six skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Under the experimental conditions described in this report, the mean score for erythema and oedema in the four rabbits used was as follows:

 

Test concentration	100%	25%	10%	5%	1%	Vehicle
Erythema	0.3	0	0	0	0	0
Oedema	0	0	0	0	0	0

 

The test item should thus not be classified as a skin irritant.

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:

1998-09-07 to 1998-09-11

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:

1992-12-29

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: Individually in PPO cages (floor area: 2576 cm^2) with perforated floor
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Undiluted

Duration of treatment / exposure:

The substance remained in the eye throughout the whole study period (last reading 72 hours after beginning of treatment)

Observation period (in vivo):

72 hours (1, 24, 48 and 72 hours after treatment)

Number of animals or in vitro replicates:

Four animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No washing was done

SCORING SYSTEM
See "Any other information on materials and methods, incl. tables" (table 1-3)

TOOL USED TO ASSESS SCORE: Fluorescein (24 hour reading), tool for other readings not specified

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks:

The score was 1 one hour after treatment

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One hour after application of the test article all animals showed some vessels definitely injected and swelling and discharge more than normal. After 24 hours there were no signs of irritation observed due to the test article in the eyes of all animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to be not irritating to the rabbit's eye.

Executive summary:

The eye irritant effect of the test item was investigated in a GLP compliant study according to OECD guideline 405. Four female albino rabbits were exposed to 0.1 mL of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing. Very slight signs of irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

	Cornea opacity	Iris lesion	Redness of conjunctiva	Oedema of conjunctiva
Test item	0.0	0.0	0.0	0.0

 

According to Regulation (EC) No 1272/2008, the test item shall not be classified as eye irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation, rabbit, RL1

The primary skin irritant effect of the test item was investigated in a GLP-compliant study according to the method recommended in OECD Guideline 404. The study was extended to investigate five different concentrations of the test article and a vehicle control on each animal. Four rabbits were exposed to different concentrations of the test article at six skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Under the experimental conditions described in this report, the mean score for erythema and oedema in the four rabbits used was as follows:

 

Test concentration	100%	25%	10%	5%	1%	Vehicle
Erythema	0.3	0	0	0	0	0
Oedema	0	0	0	0	0	0

 

The test item should thus not be classified as a skin irritant.

 

Eye irritation, rabbit, RL1

The eye irritant effect of the test item was investigated in a GLP compliant study according to OECD guideline 405. Four female albino rabbits were exposed to 0.1 mL of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing. Very slight signs of irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

	Cornea opacity	Iris lesion	Redness of conjunctiva	Oedema of conjunctiva
Test item	0.0	0.0	0.0	0.0

Based on the obtained results, the test item was considered not irritating to the eye.

 

Conclusion: The test item was not skin or eye irritating in vivo.

Justification for classification or non-classification

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

The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is considered to be not classified for skin and eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/1182.