sucrose laurate

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: granular

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6X07A106
- Expiration date of the lot/batch: May 16, 1997

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Instituut B.V.
- Age at study initiation: young adult
- Weight at study initiation: 1500-1900 g

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration: 100%

Duration of treatment / exposure:

Eye lids were held together for 1 second after dosing. Test substance was not removed.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: The following parameters were scored on a scale of 0-4, with 0 indicating no reaction, and 4 severe reaction - corneal opacity, area of cornea, and conjunctivae chemosis. The following parameters were scored on a scale of 0-3, with 0 indicating no reaction, and 3 severe reaction - ocular discharge, conjunctivae redness. The following parameters were scored on a scale of 0-2, with 0 indicating no reaction, and 2 severe reaction - Iris.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: mean of 2 highest scoring animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

other: mean of 2 highest scoring animals

Time point:

24/48/72 h

Score:

< 1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

other: Redness

Basis:

other: mean of 2 highest scoring animals

Time point:

24/48/72 h

Score:

< 2.3

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

other: Swelling

Basis:

other: mean of 2 highest scoring animals

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Irritant / corrosive response data:

Irritation effects in the cornea and conjunctivae was seen in all three animals at the 1 hour observation. All animals also showed discharge. Iris effects were seen in 2 of the three animals at this observation as well. By Day 7, irritation effects were no longer seen in 2 of the 3 animals. However, one animals showed irritation effects throughout the observation period of 21 days.

Other effects:

After installation of the test substance in the eye, the test substance turned into a paste. One animal showed ischemic necrosis of the conjunctivae, and hemorrhagic discharge at the 24 hr observation. The hemorrhaging was still seen at the 48 and 72 hr observations. This animal showed neovascularization at the observations on days 7, 14, and 21.

Any other information on results incl. tables

Eye Irritation Score (Mean Score at 24, 48, and 72 hrs)

Animal	Opacity	Iritis	Redness	Swelling
80	1.0	0.7	2.3	2.0
82	1.0	1.0	2.0	2.0
84	0.7	0.7	2.0	1.7

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

LMD was irritating to the eyes and caused damage to the eye that was not reversed in 21 days.

Executive summary:

The test substance LMD was tested for eye irritation potential. Three animals were exposed to 0.1 mL of the test substance in the eye. All animals showed irritation effects. In one animal, ischemic necrosis of the conjunctivae and hemorrhaging was observed. This animal also showed neovascularization of the cornea and irritation effects that were not fully reversed by 21 days post-exposure. The test substance is irritating to the eye and is considered a risk for serious damage to the eye.