Registration Dossier
Registration Dossier
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EC number: 242-554-8 | CAS number: 18748-98-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-09-25 to 2001-10-12
- 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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Adopted July 31, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
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:
- trimethyl(octadecyloxy)silane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals
- Strain: Crl:KBL(NZW)BR (N.Zeal.White)
- Source: Cherles River GmbH, Kißlegg, Germany
- Diet: ssniff K-H (V2333), ad libitum and hay
- Water: tap water, ad libitum
- Body weight at start of the study: 3.2-3.7 Kg
- Acclimation oeriod: 1 week under study conditions
- Housing: in fully air-conditioned rooms in seperate cages arranged in a battery
Environmental Conditions
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20%
- Photoperiod:12 hours light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Test material:
0.1 mL test item - Duration of treatment / exposure:
- single dose conjunctival administration 24 hours
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Application of the substance (0.1 mL test item) to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other:
- Remarks:
- mean/ of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- other: mean/ of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- other: mean/ of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Redness
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Executive summary:
This study was performed to assess eye irritation/corrosion potential of the test item in New zealand White rabbits according to OECD TG 405. The result of the study showed that the test substance is not irritating to eyes according to the classification criteria of direcive 93/21/EEC.
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