Dimethoxymethyloctadecylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 May - 16 Jun 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Dimethoxymethyloctadecylsilane

EC Number:

274-936-5

EC Name:

Dimethoxymethyloctadecylsilane

Cas Number:

70851-50-2

Molecular formula:

C21H46O2Si

IUPAC Name:

dimethoxymethyloctadecylsilane

Details on test material:

- Name of test material (as cited in study report): Silan ODM-Dimethoxy
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, dry, tightly closed, dark

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 2.0-2.1 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. For 8 h following test substance application the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

single application without rinsing

Observation period (in vivo):

72 h
Reading time points: 24, 48 abd 72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

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

The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours after the administration. 24 h 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:

animal #1

Time point:

other: mean after 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean after 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean after 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean after 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean after 24, 48, 72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean after 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Corneal opacity was observed at 1 h in 1/3 animals (grade 1) and was fully reversible within 48 h. No effects on iris were observed in any animal at any time point. At 1 h redness and chemosis (grade 1) were observed in 3/3 animal. These effects were fully reversible within 24 h. After fluorescein staining after 24 h corneal staining was observed in 1/3 animals (1/4 of surface). No other effects were observed.

Other effects:

No systemic intolerance reactions were observed.

Any other information on results incl. tables

Table 1: Individual results of the eye irritation study in rabbits.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	1	1	0	1
	24	0	0	0	1
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0.33
2	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
3	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

A reliable study performed in accordance with OECD 405 and GLP found the test material to be not irritating to the eye of rabbits. Corneal opacity was observed at 1 h in 1/3 animals (grade 1) and was fully reversible within 48 h. No effects on iris were observed in any animal at any time point. At 1 h redness and chemosis (grade 1) were observed in 3/3 animal. These effects were fully reversible within 24 h. After fluorescein staining after 24 h corneal staining was observed in 1/3 animals (1/4 of surface). No other effects were observed. Mean values (over 24, 48, 72 h) for cornea score were 0.33, 0, and 0 in animal 1, 2, and 3, respectively. Mean values for redness, chemosis, and iris (over 24, 48, 72 h) were 0 in all animals.