Ethyl acetoacetate

Endpoint summary

Description of key information

The test item EAA was tested for skin and irritation on rabbits. In the key study according to OECD Guideline 404 (Acute dermal irritation / corrosion) similar or equivalent to EU Method B.4. The test item was not irritant to the skin of the rabbit and no corrosive effects were noted. In the key study according to OECD Guideline 405 (Acute eye irritation / corrosion) similar or equivalent to EU Method B.5), EAA was found to be non-irritating to rabbit eyes. There is no data available on respiratory irritation. However, there is no indication for respiratory irritation from handling and use.

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:

July 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Batch-no: 15.07.83
- Storage: at 22°C in the dark

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- number of animals: 3
- Weight at study initiation: 2800-3200 mg/kg
- Housing: single housing

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml test item was applied on a 2.5 x 2.5 cm patch

Duration of treatment / exposure:

4 hours

Observation period:

Observation 30 minutes, 24 hours, 48 hours and 72 hours after removal of patch

Number of animals:

3 animals

Details on study design:

no data

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Neither erythema nor oedema were observed throughout the study.

Other effects:

none

The results are summarized below:

 

Observation	Mean values over 24, 48 & 72 hours			Mean value
	No.1	No.2	No.3
Erythema	0	0	0	0
Oedema	0	0	0	0

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was classified as non-irritant to rabbit skin

Executive summary:

The study was performed in 1983 under GLP according to OECD 404. Three albino rabbits were treated semi-occlusive with 0.5 ml test item was applied on a 2.5 x 2.5 cm patch. Observation times were 24, 48 and 72 hours after removal of the patch. Neither erythema nor oedema were observed in this study. Therefore, EAA is 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Batch-no.: 15.07.83
- Storage: at room temperature in the dark

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- number of animals: 3
- Weight at study initiation: 3200-3500 mg/kg
- Housing: single housing

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

Duration of treatment was 24 hours

Observation period (in vivo):

Obervations were done at 1, 24, 48 and 72 hours and 7, 14 and 21 days after application

Number of animals or in vitro replicates:

3 animals were used in this study

Details on study design:

The treated eyes were rinsed 24 hours after application.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: scores observed one hour after treatment

Irritant / corrosive response data:

The test item showed irritating effects in this test. All effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 48 or 72 hours after treatment.

Other effects:

Slight secretion was noted in the treated eye of one animal one hour after application.

See table above.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is slightly irritating to the rabbit eye; however classification/labelling according GHS-criteria is not necessary.

Executive summary:

The study was performed in 1983 under GLP according to OECD 405. Three albino rabbits were treated; 0.1 ml test item was applied into the conjunctival sac of the eye. Observation times were 1, 24, 48 and 72 hours and 7 days after treatment . The test item showed slight irritating effects in this test. The effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 48 and 72 hours after treatment.

In conclusion, EAA needs not to be classified as eye-irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Key – Skin irritation

A study was performed in 1983 as GLP-study according to OECD 404. Three albino rabbits were treated semi-occlusive with 0.5 ml test item was applied on a 2.5 x 2.5 cm patch. Observation times were 24, 48 and 72 hours after removal of the patch. Neither erythema nor oedema were observed in this study. Therefore, EAA is not irritating to rabbit skin.

Supporting – Skin irritation

Another study was performed in 1974, following the DOT (Transport Classification) Guidelines. 6 rabbits were used in this test. The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested (0.5 ml, was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. Erythema of score 2 were noted in 5 out of 6 animals 4h hours after removal of the patch. No oedema were observed. These findings were completely reversible within 48 hours. Therefore, EAA is not irritating to rabbit skin

Key - Eye irritation

The study was performed in 1983 according to OECD 405. Three albino rabbits were treated; 0.1 ml test item was applied into the conjunctival sac of the eye. Observation times were 1, 24, 48 and 72 hours and 7 days after treatment . The test item showed slight irritating effects in this test. The effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 48 and 72 hours after treatment.

In conclusion, EAA needs not to be classified as eye-irritant.

Waiver - Respiratory irritation

There is no data available on respiratory irritation.

Justification for selection of skin irritation / corrosion endpoint:
Guideline study; Klimisch 1

Justification for selection of eye irritation endpoint:
Guideline study; Klimisch 1

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).