Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted to a design similar to an appropriate guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observations only up to 72 hours
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): diphenylsilanediol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River (Cleon, France)
- Age at study initiation: not stated
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: polystyrene cages with perforated floor
- Diet (ad libitum): Rabbit complete pelleted maintenance diet (U.A.R., Villemoisson sur Orge, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: minimum 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 25 to 28 August 1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 46 mg (equivalent to 0.1 ml)

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
not removed

SCORING SYSTEM:

Conjunctival lesions:

Chemosis: lids and/or nictitating membranes
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

IRIS
Normal 0
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) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

Cornea
Grade
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity....................................................................................0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details
of iris clearly visible...........................................................................................1
Easily discernible translucent area; details of iris slightly obscured..................2
Nacrous area; no details of iris visible; size of pupil barely discernible............3
Opaque cornea; iris not discernible through the opacity....................................4


TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein as required

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
other: conjunctival erythema
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.17
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.72
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

In a study conducted according to OECD 405 and in compliance with GLP, diphenylsilanediol was found to be slightly irritating to rabbit eyes, the effects on the iris showing evidence of reversibility after 72 hours in some animals (further observations were not conducted). The substance does not meet the criteria for classification as Eye Irritant Category 2 according to Regulation (EC) No. 1272/2008.