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

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
Respiratory irritation: no data available 

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:

03 - 25 Nov 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 3200 - 3400 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patch held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was washed up with cottonseed oil
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin reactions were observed in any animal at any time point.

Other effects:

No signs of systemic toxicity nor effects on body weight were observed.

Interpretation of results:

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

Conclusions:

In a skin irritation study according to OECD 404 (GLP compliant) the substance was found to be not irritating to skin. Treatment of 3 female New Zealand White rabbits under semi-occlusive conditions with 0.5 mL undiluted test substance induced no skin reactions in any animal at any time point. Furthermore no signs of systemic toxicity nor effects on body weight were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

10 Nov - 02 Dec 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

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

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

Irritation parameter:

chemosis score

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

A key skin irritation study with methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is available and was performed according to OECD TG 404 and in compliance with GLP (BSL, 2003). In the study three female New Zealand White rabbits were exposed to 0.5 mL of the neat test material for 4 hours applied onto the clipped skin via semi-occlusive dressing. Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. No mortalities occurred and no remarkable body weight changes were observed during the study period. The test article did not induce any skin reactions in any animal during the study period. Furthermore no signs of systemic toxicity were observed. Based on the results of the study the test item should be considered as non-irritating.

 

Eye irritation

A key eye irritation study performed according to OECD TG 405 and in compliance with GLP with methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is available (BSL, 2003). For the assessment of the eye irritation properties 0.1 mL of the test substance was instilled in the eye of three female New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and up to 6 days post-application. No effects on cornea and iris were observed in any animal at any time point. Slight redness (grade 2) and chemosis (grade 1-2) were observed in all animals 1 h after instillation of the test substance. Mean values of redness and chemosis of each animal between 24, 48 and 72 hours post-application were 1.0, 1.33, 1.33 and 0, 0.33, 0, respectively. Redness and chemosis were fully reversible within the observation period. No remarkable body weight changes and no signs of systemic toxicitywere noted during the study period. Based on the study results and according to EU classification criteria, the test substance is considered to be non-irritating.

Justification for classification or non-classification

The available data on skin and eye irritation of Methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.