Sodium 4-propoxycarbonylphenoxide

Endpoint summary

Description of key information

Skin irritation/corrosion (OECD 404): not irritating

Eye irritation (OECD 405): corrosive

The test material, when evaluated for primary skin irritation by a 4 -hour patch test conducted on intact rabbit skin, was found to be not irritating.
The test item ether was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on cornea and conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs were irreservible.

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:

Aug 1982

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:

not specified

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Not required, the untreated sites of the same animal served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water

Duration of treatment / exposure:

4 h

Observation period:

7 d
reading time points: 1, 24, 48, 72 h and 7 d

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within:

Remarks on result:

other: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Dermal application of the test substance did result in slight erythema in only one of three animals and no edema in any of the animals tested at any observation time point.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

When evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin the test material was found to be not irritating.

Executive summary:

The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Dermal application of the test substance did result in slight erythema (fully reversible within 7 days) in only one of three animals and no edema in any of the animals tested at any observation time point.

With reference the reported effect in one of three animals and its reversibility the test substance does not need to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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:

Aug - Sept 1982

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:

not specified

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: Not required, the untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL finely powdered test substance (corresponding to max. 0.1 mg test substance)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

20 d
reading time points: 1, 24, 48, 72 h, 16 d and 20 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: At the 24 h reading time point, 1% fluorescein solution was used to stain the cornea.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Time point:

24/48/72 h

Remarks on result:

not determinable

Irritant / corrosive response data:

1 h after application all animals showed strong irritant eye effects which were not reversible within the 20 d observation period. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16.

Interpretation of results:

other: Eye Dam. 1 according to Regulation (EC) No 1272/2008

Conclusions:

Based on the observed effects and the irreversibility the substance has to be classified as Eye Dam. 1 (H318).

Executive summary:

The test item ether was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) as well as on the cornea and were observed in all animals one hour after application. These signs were not reversible within 20 d. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16.

With reference the reported scores and the irreversibility of the observed effects test substance has to be classified as Eye Dam. 1 (H318) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin irritation potential of the test substance was determined in an in vivo skin irritation test (Bayer, 1983) in New Zealand White rabbits according to OECD Guideline 404. 0.5 g of the test substance moistened with water were applied to the clipped skin of three male rabbits under semi-occlusive conditions. After an exposure period of 4 h the patch was removed and the skin sites were washed with water. Scores were taken 1, 24, 48 and 72 hours and 7 days after patch removal using the Draize scoring system. Dermal application of the test substance did result in slight erythema in only one of three animals (fully reversible within 7 days) and no edema in any of the animals tested at any observation time point. The mean scores for 24/48/72 h reading for erythema were 0, 1 and 0 and for edema 0, 0 and 0 for the 3 animals. Based on the results, the undiluted test substance was not irritating to the skin under the conditions of the test.

The test substance was tested for its eye irritant properties in 3 New Zealand White rabbits (Bayer, 1983) according to OECD Guideline 405. 1 mL of the test material was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined for effects on conjunctivae (redness and swelling) as well as on the cornea and scored according to Draize 1, 24, 48, 72 hours, 16 and 20 days after application. The mean scores for 24/48/72 h reading for corneal opacity were 3, 3.3 and 4 for each of the 3 rabbits, respectively. For conjunctivae redness and chemosis mean scores were 2 and 3 for all animals, respectively. These signs were not reversible within 20 d. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16. Based on the results of this study, the test substance was corrosive to the eye under the conditions of the test.

Justification for classification or non-classification

With reference the reported scores and the reversibility of the observed effects test substance does not have to be classified as irritant to the skin according to the criteria laid down in theEU Classification Labelling and Packaging Regulation (1272/2008/EC).

Based on the available results thetest substance has to be classified as Eye Dam. 1 (H318) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Justification for selection of skin irritation / corrosion endpoint:
Well reported guideline conform study.

Justification for selection of eye irritation endpoint:
Well reported guideline conform study

Effects on eye irritation:corrosive