Carbamic acid, N-[(dimethoxymethylsilyl)methyl]-, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Nov - 02 Dec 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test material

Test material information

Constituent 1

Reference substance name:

methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate

Cas Number:

23432-65-7

Molecular formula:

C6H15NO4Si

IUPAC Name:

methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 3800 - 4300 g
- Fasting period before study: no
- Housing: housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free, ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

single instillation without washing

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM:
Draize scoring system

TOOL USED TO ASSESS SCORE: at the end of the observation period the eyes were examined with the aid of fluorescein solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No effects on cornea and iris were observed in any animal at any time point. Slight redness (grade 2) and chemosis (grade 1-2) was observed 1 h after instillation of the test substance. Redness and chemosis were fully reversible within 6 days and 24/48 h, respectively. Slight discharge (grade 1-2) was observed in all 3 animals 1 h after instillation only.

Other effects:

No signs of systemic toxicity or effects on body weight gain were observed.

Any other information on results incl. tables

Table 1: Individual scores from eye irritation study in rabbits.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	2	1	0	0
	24	2	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	average (over 24, 48, 72 h)	1.0	0	0	0
2	1	2	2	0	0
	24	2	1	0	0
	48	1	0	0	0
	72	1	0	0	0
	96	1	0	0	0
	120	0	0	0	0
	average (over 24, 48, 72 h)	1.33	0.33	0	0
3	1	2	1	0	0
	24	2	0	0	0
	48	1	0	0	0
	72	1	0	0	0
	96	1	0	0	0
	120	1	0	0	0
	144	0	0	0	0
	average (over 24, 48, 72 h)	1.33	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:

In an eye irritation study according to OECD 405 (GLP compliant) the substance was found to be not irritating to eyes. Treatment of 3 female New Zealand White rabbits with 0.1 mL undiluted test substance resulted in no effects on cornea and iris in any animal at any time point. Slight conjunctival redness (grade1-2) and chemosis (grade 1-2) were observed, but were fully reversible within 6 days at the latest. Furthermore no signs of systemic toxicity nor effects on body weight were observed.