Registration Dossier

Toxicological information

Eye irritation

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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:
2001
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

Constituent 1
Chemical structure
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

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.