Isobutylisopropyldimethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 September 1987 to 15 October 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in acccordance with an acceptable scientific method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

According to the score system in "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" U.S. Department of Health, Education and
Welfare, Food and Drug Administration Washington, D.C. 20204.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isobutylisopropyldimethoxysilane

EC Number:

402-580-4

EC Name:

Isobutylisopropyldimethoxysilane

Cas Number:

111439-76-0

Molecular formula:

Hill formula: C9H22O2Si

IUPAC Name:

dimethoxy(2-methylpropyl)(propan-2-yl)silane

Details on test material:

Batch No. of ZK 119.649
)riginal formulation: W87/75-82
Stability of ZK 119.649: at least stable till April/May 1988, if stored in closed vessels at room temperature.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Number of animals and strain: 4 New Zealand White rabbits, 2M, 2F
Animal quality: conventional
Breeder: Schriever
Acclimatization time: > 25 days; during this period a diet containing 0.03% sulfaquinoxaline was offered for 7 consecutive days as coccidiosis prophylaxis.
Caging conditions: conventional
Cage type: metal cage
Animals per cage: 1
Number of groups: 1
Body weight: males: 3.1-3.3 kg, females: 3.0-3.2 kg
Feed type: pell. Altromin K
Feeding time: ad libitum
Type of drinking water: demineralized water
Watering time: ad libitum
Room temperature: 20-23°C
Relative humidity: 46-86%
Light period: 12 hours day-night cycle
Identification: ear tattooing

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated left eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 mL
- Concentration (if solution): Original formulation

Duration of treatment / exposure:

15 or 17 days

Observation period (in vivo):

Observations were performed before, 0.5, 1 and 2h after application and once daily until day 15 or 17 of the test.

Number of animals or in vitro replicates:

4 (2 female and 2 male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: Not applicable

SCORING SYSTEM: According to the score system in "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" U.S. Department of Health, Education and Welfare, Food and Drug Administration Washington, D.C. 20204.

TOOL USED TO ASSESS SCORE: No information.

Results and discussion

In vivo

Results

Remarks on result:

other: According to the score system in "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" 1 out of 4 animals reacted positively. See table attached under background information.

Irritant / corrosive response data:

According to the score system in "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" 1 out of 4 animals reacted
positively. See table attached under background information.

In all treated animals, the outer eyelids revealed very slight to severe swellings of the margin of eyelid and secretions with moistening of eye-surrounding fur. The skin of the outer eyelid displayed very slight to moderate reddening and complete or incomplete eyelid closure in all treated animals, too.
Concerning conjunctival alterations the treated animals showed very slight to severe reddening, swellings of conjunctiva palpebrae and injections of blood vessels of conjunctiva sclerae (in toto or only visible at the temporal part of sclerae). The remaining conjunctival alterations as reddening, swellings, injections of blood vessels of membrana nictitans and injections of blood vessels of conjunctiva palpebrae in all treated animals as well as purulent secretion in 3 out of 4 animals were evaluated as very slight to moderate changes. In only one animal the surface of cornea was uneven and blunt on day 1 and day 2 of the study. With the exception of one animal, which in addition to the substance caused lesions still revealed a secondary bacterial conjunctivitis between day 5 and day 14 of the study, the remaining animals exhibited local findings on the treated eye only between day 1 (all animals) and day 6 (2 animals).

Other effects:

The control eyes (left eye) were without any local findings over the whole observation period in all animals.
Body weight was unchanged during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the score system in "Illustrated Guide for Grading Eye Irritations by Hazardous Substances" 1 out of 4 animals reacted positively.
The substance is not classified as an eye irritant according to the CLP regulation.

Executive summary:

A local tolerance test on the rabbit conjunctiva was conducted with a single application of the test substance.

According to the score system in "Illustrated Guide for Grading Eye Irritations by Hazardous Substances" 1 out of 4 animals reacted positively.

The substance is not classified as an eye irritant according to the CLP regulation.