Registration Dossier
Registration Dossier
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EC number: 935-756-9 | CAS number: 1344-95-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 October - 11 November 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- crystalline calcium silicate hydrate (xonotlite - tobermorite)
- IUPAC Name:
- crystalline calcium silicate hydrate (xonotlite - tobermorite)
- Reference substance name:
- calcium oxosilanebis(olate)
- EC Number:
- 935-756-9
- Cas Number:
- 1344-95-2
- Molecular formula:
- Xonotlite Ca6Si6O17(OH)2 Tobermorite Ca5(Si6O16)(OH)2.4H2O
- IUPAC Name:
- calcium oxosilanebis(olate)
- Reference substance name:
- Amorphous silicic acid, calcium salt
- Molecular formula:
- CaSiO3.nH2O
- IUPAC Name:
- Amorphous silicic acid, calcium salt
- Details on test material:
- - Name of test material (as cited in study report): crystalline calcium silicate hydrate (xonotlite - tobermorite)
- Physical state: solid
- Analytical purity: confidential information
- Lot/batch No.: confidential information
- Expiration date of the lot/batch: confidential information
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quafier Labaste - F40260 Linke)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.65-3.17 kg during test
- Housing: individual wire floored stainless steel cages of dimensions 61 cm x 46 cm x 36 cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): from 30% to 70%
- Air changes (per hr): at least 10 cycles per hour
- Photoperiod (hrs dark / hrs light): circadian cycle (12 hrs day/12 hrs darkness)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- At 1 hour after test item instillation, remaining test item was rinsed
- Observation period (in vivo):
- 9 days (observations after 1, 24, 48, 72 hrs and 4, 8, and 9 days)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological rinse
- Time after start of exposure: 1 hour
SCORING SYSTEM: in accordance with OECD Guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hrs mean
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs mean
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hrs mean
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hrs meand
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hrs score
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- - conjunctivae: moderate redness noted after 1 hr, totally reversible between day 6-9, moderate to important chemosis noted after 1 hr, totally reversible between day 6-8
- iris: congestion noted after 24 hr, totally reversible on day 2
- corneal: slight corneal opacity after 1 hr, totally reversible between 3-6 - Other effects:
- After 1 hr, lachrymation with moistening of the eyelids and large areas aroound the eye was observed in all animals. This effect was fully reversible within 24 hours (animal 2 and 3) or 48 hrs (animal 1).
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information according to CLP Criteria used for interpretation of results: EU
- Conclusions:
- Crystalline calcium silicate hydrate (xonotlite - tobermorite) induced corneal opacity and conjunctival redness. Based on the calculated means, the test item must according to Annex I of 1272/2008/EC (CLP/EU-GHS) be classified in category 2 "irritating to eyes".
- Executive summary:
An in vivo eye irritation test was performed in accordance with OECD Guideline 405 to assess the eye irritation potential of crystalline calcium silicate hydrate (xonotlite - tobermorite). The test item induced corneal opacity and conjunctival redness, but all effects were fully reversible within 9 days. Based on the calculated means, the test item must according to Annex I of 1272/2008/EC (CLP/EU-GHS) be classified in category 2 "irritating to eyes".
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