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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Apr - 23 May 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Groupe interministeriel des produits chimiques, France

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lithium silicate
- Physical state: white powder
- Analytical purity: >99%
- Lot/batch No.: 2010850928gf
- Expiration date of the lot/batch: 2011-11-18
- Storage condition of test material: room temperature
- Other:
Molar Ratio SiO2/Li2O: 4.8 (information provided in the product information sheet for Lithium polysilicate by the data owner)

Test animals / tissue source

Species:
rabbit
Strain:
other: albino New Zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 11 or 13 weeks
- Housing: individual in boxes, bedding: Aspen brick
- Diet (e.g. ad libitum): SDS - C15, ad libitum
- Water (e.g. ad libitum): tap-water from public distribution system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 Apr 2011 To: 23 May 2011

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
single exposure
Observation period (in vivo):
21 days
Reading time points: 1, 24, 48 and 72 h, 4, 7, 8, 9, 10, 11, 14, 15, 16, 17, 18 and 21 days
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 16 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7days
Irritation parameter:
iris score
Basis:
other: mean out of animals #2 and #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 16 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
for details on results refer to table 1-3
Other effects:
Animal #1: swelling of the cornea on day 4 and day 7; corneal neovascularisation between day 7 and day 14, on day 11 and day 15
Animal #2: swelling of the cornea between day 2 and day 4
Animal #3: white secretion requiring a physiological rinse on day 1 and day 2; swelling of the cornea between day 2 and day 18; corneal neovascularisation betwenn day 10 and day 21

Any other information on results incl. tables

Table 1: Individual scores of ocular irriation of animal #1

Observation time

Conjunctivae

Iris

Cornea

redness

swelling

1 h

3

3

1

1

24 h

3

2

1

2

48 h

3

3

1

3

72 h

2

2

1

3

Day 4

2

2

1

3

Day 7

1

0

0

3

Day 8

1

0

0

3

Day 9

1

0

0

2

Day10

1

0

0

2

Day 11

1

0

0

2

Day 14

1

0

0

2

Day 15

1

0

0

2

Day 16

0

0

0

0

 

Table 2: Individual scores of ocular irriation of animal #2

Observation time

Conjunctivae

Iris

Cornea

redness

swelling

1 h

2

3

1

0

24 h

3

3

1

2

48 h

2

1

1

2

72 h

2

1

1

2

Day 4

2

1

0

2

Day 7

2

0

0

0

Day 8

1

0

0

0

Day 9

1

0

0

0

Day10

0

0

0

0

 

Table 3: Individual scores of ocular irriation of animal #3

Observation time

Conjunctivae

Iris

Cornea

redness

swelling

1 h

3

3

1

2

24 h

3

3

1

2

48 h

3

2

1

2

72 h

3

2

1

2

Day 4

2

2

0

2

Day 7

0

1

0

2

Day 8

0

0

0

2

Day 9

0

0

0

2

Day10

0

0

0

2

Day 11

0

0

0

2

Day 14

0

0

0

2

Day 15

0

0

0

2

Day 16

0

0

0

2

Day 17

0

0

0

2

Day 18

0

0

0

2

Day 21

0

0

0

2

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye Damage 1, H318
DSD: Xi, R41