Ceramic materials and wares, chemicals

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: lack of details on test substance

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

: lack of details on test substance

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

LDSF® LT

IUPAC Name:

LDSF® LT

Details on test material:

- Name of test material (as cited in study report): LDSF® LT
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 90122

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated right eye served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Until the observation period of 16 days.

Observation period (in vivo):

16 days (because of the intensity of the lesions and according to the qualified veterinarian diagnosis, the study was stopped on D16)

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.33

Max. score:

2

Reversibility:

other: Iris lesions were observed 24 hours after instillation and on day 8.

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

3.33

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

One hour after instillation, the animal had a severe chemosis (score 4) with lacrimation (score 2) and a severe redness of the conjunctivae (score 3). Chemosis (score 3 to 4) and redness of conjunctivae (score 2 to 3) persisted up to D 16.
Iris lesions were observed 24 hours after instillation and on D 8.
On D 15, corneal lesions (score 2) involved an aera of a quarter or less of the total aera were observed.
On D 16, greater than three-quarters, up to whole aera was observed.
Pus in the conjunctival sac was also observed 24 hours after instillation.
Because of the intensity of the lesions and according to the qualified veterinarian diagnosis, the study was stopped on D16.

Any other information on results incl. tables

Table 1: Mean index:

Treatment	Animal number	Chemosis	Redness	Iris	Cornea
LDSF^®LT	1	3.33	3	0.33	0

Applicant's summary and conclusion

Interpretation of results:

other: severe irritating

Remarks:

Criteria used for interpretation of results: other: DSD and CLP

Executive summary:

Bouchard, A. (2010)

In a primary irritation study, the eye irritation potential of LDSF^® LT (Batch No.90122) was tested. 0.1 g of the test substance was introduced into the conjunctival sac of the left eye of each of the four animals. The untreated right eye served as a control.

Only one animal was used for the study because LSDF^® LT caused local pain and was probably severely irritating or corrosive. Therefore, exposure of two additional animals was not done.

 

The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.

 

Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours for two animals and 8 days, 15 days and 16 days after instillation of LDSF^® LT (monitoring was stopped before the end of reversibility period).

Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours.

Results obtained were as follows:

One hour after instillation, the animal had a severe chemosis (score 4) with lacrimation (score 2) and a severe redness of the conjunctivae (score 3). Chemosis (score 3 to 4) and redness of conjunctivae (score 2 to 3) persisted up to D 16.

Iris lesions were observed 24 hours after instillation and on D 8.

On D 15, corneal lesions (score 2) involved an area of a quarter or less of the total area were observed.

On D 16, greater than three-quarters, up to whole area was observed.

Pus in the conjunctival sac was also observed 24 hours after instillation.

Because of the intensity of the lesions and according to the qualified veterinarian diagnosis, the study was stopped on D16.

 

Because ocular lesions and animal pain increased during the reversibility period and under the experimental conditions adopted, LSDF^®LT (Batch No. 90122) should be classified as Irritant-Category 1 for the eye of the rabbit.

Classification according to DSD Directive No. 67/548/EC and subsequent amendments:

Symbol: Xi.

Indication of danger: Irritant.

Risk phrase: R41: Risk of serious damage to eyes.