Registration Dossier
Registration Dossier
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EC number: 603-157-9 | CAS number: 12676-29-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD testing guideline and under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Boron silicate
- EC Number:
- 603-157-9
- Cas Number:
- 12676-29-8
- Molecular formula:
- H7 B7 Si57 O128
- IUPAC Name:
- Boron silicate
- Details on test material:
- Name of test item: silicon boride oxide
Homogeneity: The test item was homogeneous by visual inspection.
Expiry date: January 01, 2036
Storage conditions: Room temperature, protect against humidity
Physical state/ color: Solid / white
pH-value: Approx. 2 (moistened with water, determined by
Bioassay)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: Approx. 3 months
- Sex: Females
- Weight at study initiation: 2.45 kg – 3.01 kg
- Housing: Single
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 16 mg of the comminuted test item) - Duration of treatment / exposure:
- 24 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
SCORING SYSTEM: The evaluation of eye irritation was performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0.7
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Irritant / corrosive response data:
- Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to 24 or 48 hours after application, respectively.
Slight conjunctival chemosis (grade 1) was noted in two out of three animals 1 hour after application and in the third animal 24 hours after application.
Slight discharge (grade) was noted in two out of three animals 1 hour after application.
Additional findings like injected scleral vessels in a circumscribed area were noted in one animal from hour 1 until hour 48 after application. Test item residues were observed in two out of three animals 1 hour after application only.
The ocular reactions were reversible in all animals within 72 hours after application at the latest.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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