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EC number: 234-796-8 | CAS number: 12033-89-5
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 February 2005 - 18 February 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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
Test material
- Reference substance name:
- Trisilicon tetranitride
- EC Number:
- 234-796-8
- EC Name:
- Trisilicon tetranitride
- Cas Number:
- 12033-89-5
- Molecular formula:
- N4Si3
- IUPAC Name:
- 1Si-hexacyclo[3.1.1.0¹,⁴.0²,⁵.0³,⁶.0³,⁷]trisilazane
- Details on test material:
- - Name of test material (as cited in study report): "SILICON NITRIDE Si3N4"
- Molecular formula (if other than submission substance): Si3N4
- Physical state: Light grey powder
- Analytical purity: > 97 %,
- Lot/batch No.: 2607/04-FS
- Stability under test conditions: In closed container: at least 1 year
- Storage condition of test material: Dry. Ambient temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, 0-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, adlibitum. Hay-briquettes are offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
-Acclimatisation: 5 days (animal No. 11) and 12 days (animals Nos. 12 and 13)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.0°C (continuous control and recording)
- Humidity (%): Average of 50.6 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light):12/12
The animals were killed by inhalation of 80 % C02 + 20 % air.
Test system
- Controls:
- other: the untreated (left) eyes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The weighed amounts of the individual doses were 43, 46 and 45 mg (equivalent of 0.1 mL). - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a.
No further examinations were performed thereafter.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined, using an otoscope lamp. - Number of animals or in vitro replicates:
- 3 (females)
- Details on study design:
- SCORING SYSTEM:
Scoring scheme for eye lesions
CORNEA
Opacity: degree of density (area most dense is taken for reading).
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre), details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The following mean scores were calculated for each animal from the examinations 24 h, 48 hand 72 h p.a.:
Mean Scores for Animal No.:
11 12 13
Cornea 0.0 0.0 0.0
Irises 0.0 0.0 0.0
Conjunctivae, redness 0.0 0.0 0.3
Conjunctivae, chemosis 0.0 0.0 0.0
Ocular lesions were reversible in all animals within 48 h p.a.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to Commission Directive 2001/59/EC "SILICON NITRIDE Si3N4" does not require classification for eye irritation.
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