Registration Dossier
Registration Dossier
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EC number: 606-938-2 | CAS number: 2212-11-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002-06-19 until 2002-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Good laboratory practice guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Chloromethyl)trimethoxysilane
- EC Number:
- 611-813-0
- Cas Number:
- 5926-26-1
- Molecular formula:
- C4H11ClO3Si
- IUPAC Name:
- (Chloromethyl)trimethoxysilane
- Details on test material:
- - Name of test material (as cited in study report): Silane 434106 VP
- Substance type: intermediate
- Physical state: liquid
- Stability under test conditions: pure: stable, in Water: hydrolysis in water
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 3.3- 4.0 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12hdark, 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untrated eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Observation period (in vivo):
- 168 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: as laid down in OECD Guideline 405
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 168 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- 24/48/72 h
- Score:
- >= 0.67 - <= 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 120 h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance has not to be classified as irritant according to the EU regulations.
- Executive summary:
An eye irritation study was conducted with (Chloromethyl) trimethoxysilane on three New Zealand White Rabbits by administering 0.1 ml of the substance. The mean scores of the 24, 48 and 72 hour readings did not exceed the limit values according to Directive 93/21 EEC in any case.
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