Sodium 4-propoxycarbonylphenoxide

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-propoxycarbonylphenoxide

EC Number:

252-488-1

EC Name:

Sodium 4-propoxycarbonylphenoxide

Cas Number:

35285-69-9

Molecular formula:

C10H12O3.Na

IUPAC Name:

propyl 4-hydroxybenzoate

Test material form:

other: solid

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 10

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.

Applicant's summary and conclusion

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).