Diphenylsilanediol

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

observations only up to 72 hours

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

000947-42-2

Cas Number:

000947-42-2

IUPAC Name:

000947-42-2

Constituent 2

Reference substance name:

Diphenylsilanediol

EC Number:

213-427-4

EC Name:

Diphenylsilanediol

Cas Number:

947-42-2

Molecular formula:

C12H12O2Si

IUPAC Name:

diphenylsilanediol

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

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.22

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

other: conjunctival erythema

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.17

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

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.