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EC number: 235-730-0 | CAS number: 12627-14-4
Eye irritation
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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe interministeriel des produits chimiques, France
Test material
- Reference substance name:
- Silicic acid, lithium salt
- EC Number:
- 235-730-0
- EC Name:
- Silicic acid, lithium salt
- Cas Number:
- 12627-14-4
- Molecular formula:
- Li2O*2.8SiO2 - Li2O*6.3SiO2
- IUPAC Name:
- Silicic acid, lithium salt
- 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)
Constituent 1
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
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