H112323

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 4266-4412 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

1-2 h, Day 1, 2 , 3, 4, 6 and 7 of application

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scale to assess the grade of ocular reaction and A modified form of the Kay and Calandra system was used to interpret and classify the numerical scores. As an aid in the assessment of corneal damage, fluorescein staining was used at the 1, 2 (2 animals), 3, 4, 6 and 7-d readings.

TOOL USED TO ASSESS SCORE: Fluorescein staining

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Remarks on result:

other: Redness could not be fully assessed due to staining of the cornea but is unlikely to have occurred

Irritant / corrosive response data:

Application of the test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the remaining rabbits were treated with a local anaesthetic prior to application and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test sample obscured any underlying redness which may have been present. However as the conjunctival effects were limited to a severe, but transient, discharge in one animal and an intermittent slight discharge in another animal, it is considered unlikely that significant redness was present in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance was considered to be not irritant to the rabbit eye

Executive summary:

A study was conducted to assess the eye irritation potential of test substance to the rabbit eye equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP.

Instillation of the undiluted test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the other two rabbits were therefore treated with a local anaesthetic prior to dosing and these animals showed no initial pain following application.

Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test substance obscured any underlying redness that may have been present. However, as the observed ocular effects were limited to transient/intermittent conjunctival discharge it is considered unlikely that significant conjunctival redness was present in any of the animals.

As the staining is limited to the conjunctiva and no corneal effects occurred It is hence concluded that the test substance has no irritating effects on the rabbit eye.