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Diss Factsheets

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:
13 Feb to 17 Feb 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethoxydiphenylsilane
EC Number:
229-929-1
EC Name:
Dimethoxydiphenylsilane
Cas Number:
6843-66-9
Molecular formula:
C14H16O2Si
IUPAC Name:
dimethoxydiphenylsilane
Details on test material:
- Name of test material (as cited in study report): DYNASYLAN D 6010 (dimethoxydiphenylsilan)
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Less than one year
- Storage condition of test material: Protected from moisture

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische fabrik
- Age at study initiation: 'adult'
- Weight at study initiation: 2.2-2.5 kg
- Housing: Individually in stainless steel cages
- Diet: Ssniff K4 (rabbit diet), Ssniff GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12

IN-LIFE DATES: From: 13.02.1995 to 17.02.1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring scheme

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24. 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 chemosis at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 chemosis at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 chemosis at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 reaction at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 reaction at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Grade 1 reaction at 24 hours, but no reaction evident at 48 and 72 hours.
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
other: No effect on iris observed in any animal at any time point.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
other: No corneal effects observed in any animal at any time point.
Irritant / corrosive response data:
Grade 2 conjunctival redness was observed in all three rabbits one hour after treatment, and declined to grade 1 by 24 hours. Grade 1 conjunctival chemosis was observed at 1 hour and 24 hours in all three animals. There was no sign of irritation in any of the animals by 48 hours. There were no signs of irritation in the corneal or iris.
Other effects:
There was some discharge in two of the animals after one hour.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) dimethoxydiphenylsilane was not irritating to the eyes of rabbits.