Tetravinylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2019-06-04 to 2019-06-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2017

Deviations:

yes

Remarks:

Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetravinylsilane

EC Number:

214-192-0

EC Name:

Tetravinylsilane

Cas Number:

1112-55-6

Molecular formula:

C8H12Si

IUPAC Name:

tetraethenylsilane

Test material form:

liquid

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.5%

Test animals / tissue source

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 98-115 days
- Weight at study initiation: 2373.6-2517.0 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 8-15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 48-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL test item

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Initial Test: 1
Confirmatory Test: 2

Details on study design:

ADMINISTRATION METHOD
- Dosing: The rabbits were held firmly but gently until quiet. 0.1 mL of the test item was placed in the conjunctiva! sac of right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were gently held together for approximately one second in order to prevent loss of the material. The left eye remained untreated and served as a control.
- Dosing Frequency: Each animal was dosed once.
- Dosing Time: In the morning.
The time interval between initial test and confirmatory test was about 6 days

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein sodium and slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration
There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration.

Other effects:

- Clinical Observations:
No adverse systemic effects were observed in any animals during the study.
- Body Weights
The body weights of all animals showed growth trends during the observation periods.

Any other information on results incl. tables

Eye Reaction Scoring:

No.	Conjunctivae				Chemosis				Cornea opacity				Iris
	24h	48h	72h	Mean	24h	48 h	72 h	Mean	24h	48h	72 h	Mean	24h	48h	72 h	Mean
1100	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1101	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1102	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The test item was considered to not be irritating to eye in rabbits.

Executive summary:

The study was performed to assess the acute eye irritation/corrosion of test item in rabbits in accordance with OECD 405.

Three male rabbits were used for the study. Each animal was administered about 0.1 mL of the test item into right eye. Untreated left eye served as the control.

No adverse systemic effects were observed in any animals during the study.

Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration

There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration.

Individual and mean scores of Cornea Opacity, Iris, Conjunctival Redness and Chemosis were all 0 for three treated eyes at approximately 24, 48, 72 hours after administration.

The body weights of all animals showed growth trends during the observation periods

The test item was considered to not be irritating to eye in rabbits.