Isobutylisopropyldimethoxysilane

Endpoint summary

Description of key information

The substance is a skin irritant according to the results of an in vivo study conducted in New Zealand White rabbits (OECD Guideline 404).

The substance is not an eye irritant according to the results of an in vivo study conducted in New Zealand White rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data.

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

No data

Number of animals:

4

Details on study design:

No data

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 48hours

Score:

2

Max. score:

2

Reversibility:

no data

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

2

Max. score:

2

Reversibility:

no data

Irritant / corrosive response data:

No data

Other effects:

No data

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The results of an in vivo study conducted in New Zealand White rabbits (OECD Guideline 404) showed that the test substance is irritating to the skin. The test substance was not irritating to the eyes in an in vivo study conducted in New Zealand White rabbits.

Justification for selection of skin irritation / corrosion endpoint:

Only one study is available.

Justification for selection of eye irritation endpoint:

Only one study is available.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered classification under the CLP Regulation (EC No 1272/2008) as a category 2 skin irritant. No classification is required for effects on the eyes.