Registration Dossier
Registration Dossier
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EC number: 943-282-9 | CAS number: -
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trimethyl(octadecyloxy)silane
- EC Number:
- 242-554-8
- EC Name:
- Trimethyl(octadecyloxy)silane
- Cas Number:
- 18748-98-6
- Molecular formula:
- C21H46OSi
- IUPAC Name:
- Silane, trimethyl(octadecyloxy)-
- Test material form:
- other: liquid
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 Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.2-3.7 kg
- Housing: separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333 ad libitum and approximately 15 g hay daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): isotonic saline at approximately 37°C
- Time after start of exposure: 24 hours
The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination fluorescein was performed
SCORING SYSTEM:
Cornea:
- Opacity: degree of density (area most dense taken for reading)
0 - no ulceration or opacity
1 - scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 - easily disernible translucent area, details of iris slightly obscured
3 - nacrous area, no details of iris visible, size of pupil barely discernible
4 - opaque cornea, iris not discernible through the opacity
- Affected area (opacity or stained by fluoresceine test)
0 - no translucence
1- punctate to 1/4
2 - more than 1/4 to 1/2
3 - more than 1/2 to 3/4
4 - more than 3/4 to 4/4
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 reacion is positive)
2 - no reaction to light, haemorrhage, gross destruction (any or all of these)
Conjuctivae:
- Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
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 nicating membranes)
0 - no swelling
1 - any swelling above normal (includes nicating membrane)
2 - obvious swelling with partial eversion of lids
3 - swelling with lids about half closed
4 - swelling with lids more than half closed
- Discharge
0 - no discharge
1 - any amount different from normal (does not include small amounts normally observed in inner canthus)
2 - discharge with moistening of the lids and hairs just adjacent to the lids
3 - discharge with moistening of the lids hairs and considerable area around the eye
TOOL USED TO ASSESS SCORE: UV light, 0.01% fluorescein-sodium solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 16
- Remarks on result:
- other: Redness was observed in 2/3 animals and discharge in 3/3 animals 1 hour after treatment but was resolved by 24 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1 hour after treatment, the conjunctivae of the eyes showed hyperaemic blood vessels in 2 animals. Additionally serious and colourless eye discharge was observed. 24 hours after treatment all signs of irritations were reversed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study conducted according to OECD 405 and compliant with GLP, trimethyl(octadecyloxy)silane) was found to be not irritating to eyes.
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