Silanediol, 1-methyl-1-(1-methylethoxy)-, 1,1-diacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 May - 24 Jul 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-070-9

EC Name:

-

Cas Number:

329039-38-5

Molecular formula:

Hill formula: C8 H16 O5 Si CAS formula: C8 H16 O5 Si

IUPAC Name:

(acetyloxy)(methyl)(propan-2-yloxy)silyl acetate

Details on test material:

- Name of test material (as cited in study report): Methyldiacetoxyisopropoxy Silane
- Physical state: Clear, colorless liquid
- Analytical purity: 85.8 %
- Impurities (identity and concentrations): 12.9 % Acetoxydiisopropoxymethtylsilane, 1.3 % hydrolisis product (siloxane)
- Purity test date: 04.10.2001
- Lot/batch No.: AA001 (04/10/01)
- Stability under test conditions: Hydrolyzes to form poly(silicone); store under Nitrogen
- Storage condition of test material: Use ground strap and store under nitrogen in original container below 30 °C (85 °F) in hood.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Age at study initiation: 10 weeks
- Weight at study initiation: 2.08 - 2.20 kg
- Housing: Individual housing (suspended stainless-steel cages), bedding in hardwood chips (non-contact), Prochip, Harlan Teklad, Madison, WI
- Diet: TEK 8630 Rabbit Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Minimum 5 days, under the same conditions as for the actual test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12, full spectrum fluorescent lights

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

4 (2 males and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed after instillation

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

ADDITIONAL INFORMATION: An initial procedure using a 10% dilution of the test substance was performed on one animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 11 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 10 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 11 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 15 days

Irritant / corrosive response data:

The undiluted test substance caused severe eye irritation in all three animals. Corneal opacity, iris response, conjunctival redness, and chemosis were observed in all treated eyes. The irritation response resolved slowly and the effects were reversible between Day 5 for cornea and iris effects and Day 15 for chemosis (Table 1).
No irritation effects were observed in an initial procedure using a 10% dilution of the test substance on one animal (Table 2).

Any other information on results incl. tables

Table 1. Individual results of the eye irritation study (undiluted test substance)

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1	2	3	1	2
	24	3	4	2	4
	48	3	4	2	4
	72	3	4	2	4
	average	3.0	4.0	2.0	4.0	Time to reversion	Day 11	Day 15	Day 14	Day 9
2	1	2	3	1	1
	24	2	3	1	2
	48	2	3	1	1
	72	2	3	1	1
	average	2.0	3.0	1.0	1.33	Time to reversion	Day 10	Day 15	Day 5	Day 5
3	1	2	3	1	2
	24	2	4	1	2
	48	3	4	2	3
	72	3	4	2	3
	average	2.67	4.0	1.67	2.67	Time to reversion	Day 11	Day 15	Day 7	Day 7

Table 2. Individual results of the preliminary eye irritation study (10% dilution of the test substance)

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
4	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0	Time to reversion	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Eye irrit 1, H318
DSD: Xi, R41

Executive summary:

The primary eye irritation potential of methyldiacetoxyisopropoxy silane was investigated by instillation of 0.1 mL into the left eye of one young adult New Zealand White rabbit in a GLP-Guideline study. The undiluted test substance caused severe eye irritation in all three animals. Corneal opacity, iris response, conjunctival redness, and chemosis were observed in all treated eyes. The irritation response resolved slowly and the effects were reversible between Day 5 for cornea and iris effects and Day 15 for chemosis.

Based upon the classification criteria of EEC Commission Directive 93/21/EEC, methyldiacetoxyisopropoxy silane is considered to be “R41- Risk of serious damage to eyes” and category 1 "cause serious eye damage" according to GHS, respectively.