Tetrapropyl orthosilicate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.04.2002 to 13.08.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrapropyl orthosilicate

EC Number:

211-659-0

EC Name:

Tetrapropyl orthosilicate

Cas Number:

682-01-9

Molecular formula:

C12H28O4Si

IUPAC Name:

tetrapropyl silicate

Details on test material:

- Name of test material (as cited in study report): Silan TPN
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions: >1 year at 25 oC
- Storage condition of test material: Room temperature, dry, tightly closed

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT
- Age at study initiation: 2.5-3 months
- Weight at study initiation: 1.8-2.1 kg
- Housing: Animals were kept singly in cages with dimensions of 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.04.2002 To: 03.05.2002

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of animals served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

The eyes were held together for about one second in order to prevent loss of the material. The eyes were not rinsed.

Observation period (in vivo):

72 hours after administration

Number of animals or in vitro replicates:

Three male animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: According to OECD 405.

TOOL USED TO ASSESS SCORE: Eyes were exmined ophthalmoscopically with a hand-slit lamp and 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: All animals grade 1 at one hour

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: One animal grade 1 at one hour.

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 2 and 3

Time point:

other: Mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Grade 1 at one hour, which had reversed by 24 hours.

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: All animals Grade 1 at one hour.

Irritant / corrosive response data:

No additional data.

Other effects:

No other effects.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation study conducted to OECD 405 and to GLP (reliability score 1), tetrapropyl orthosilicate was not irritating to the eyes of rabbits.

Executive summary:

In an eye irritation study conducted according to OECD 405 and GLP, Silan TPN (0.1 ml) was instilled into the conjunctival sac of the right eye of three male Himalayan rabbits. The left eyes served as controls. The right eyes were held shut for approximately one second to prevent loss of the test substance. Eyes were examined ophthalmoscopically with a slit lamp prior to the administration and at 1, 24, 48 and 72 hours after the treatment. Reactions were scored according to OECD 405. All animals were observed to have grade 1 corneal opacity, conjunctival redness, and conjunctival chemosis at one after treatment. One animal also had grade 1 iris irritation one hour after treatment. Conjunctival redness (grade 1) was observed in one animal 24 hours after treatment. All of these effects were reversed by 72 hours.