N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine

Endpoint summary

Description of key information

In the key skin irritation study conducted according to OECD Test guideline 404 and in compliance with GLP (Toxikon Corporation, 2007) N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was concluded to be not irritating to the skin of rabbits.

There are no eye irritation studies for N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine, therefore good quality reliable data have been read-across from the structurally-related substance, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3).  

In the key eye irritation study, which was conducted according to OECD Test Guideline 405 and in compliance with GLP, 1,1,1,3,3,3-hexamethyldisilazane was not irritating to rabbit eyes (Dow Corning Corporation, 1993b).

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:

02.04.2007 to 08.10.2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No test substance purity details.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: At least 10 weeks old
- Weight at study initiation: 2.07-2.19 kg
- Housing: Suspended stainless steel
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 5
- Humidity (%): 30-70
- Air changes (per hr): Minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 04.10.2007 To: 08.10.20007

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

Four hours

Observation period:

72 hours (at 1, 24, 48 an 72 hours)

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Trunk
- % coverage: Not less than 10%
- Type of wrap if used: Covered with a gauze patch, which was held in place with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance was removed by washing with sterile water.
- Time after start of exposure: Four hours

SCORING SYSTEM: Equivalent to Draize.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At the 1-hour time interval two animals had Grade 1 erythema. In one of these animals the Grade 1 erythema continued to 48 hours but was completely resolved by 72 hours. In the other the erythema had resolved by 24 hours. There were no signs of irritation in the third animal.

Other effects:

There were no overt signs of toxicity, and all animals gained weight during the study.

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study conducted according to OECD Test guideline 404 and in compliance with GLP, N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was concluded to be not irritating to the skin of rabbits.

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:

07.09.1993 to 06.12.1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Age:  Young male adult rabbits weighing between 2.7 and 2.85 kg
No further data - details taken from IUCLID 2008
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.7 to 2.85 kg
- Housing: Individually in stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: From: 26.10.1993 To: 29.10.1993

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

No washing

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Fluorescein stain was used at the 24, 48, and 72-hour readings. Eyes were examined by slit illumination for ocular changes of the cornea, iris (internal effects) and conjunctiva.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

Both before and after stain

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

Both before and after stain

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

Both before and after stain

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See Table 1. The test material caused slight conjunctival hyperemia in two animals and slight conjunctival chemosis in one animal at the 1 hour reading; these reactions had subsided at the subsequent readings (2 or 24 hours). The primary eye irritation score was calculated for the animals to be 0 (non-irritating).

Other effects:

A very slight immediate pain response was observed in all animals. 

Table 1 Mean irritation scores

Individual Tissue parameter	1 hour	2 hours	24 hours	48 hours	72 hours
Corneal Opacity	-	-	0	0	0
Iridial inflammation	0	0	0	0	0
Conjunctival irritation
Redness	0.7	0	0	0	0
Chemosis	0.3	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, which was conducted according to OECD Test Guideline 405 and in compliance with GLP, 1,1,1,3,3,3-hexamethyldisilazane was not irritating to rabbit eyes

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key skin irritation study with N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was conducted according to OECD Test Guideline 405 and in compliance with GLP. No adverse skin reactions were observed at the 24, 48 and 72-hour observations following 4-hour, semioccluded application of undiluted test material onto rabbit skin (Toxicon Corporation, 2007).

In a skin irritation study with 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3), conducted according to OECD Test Guideline 404 and in compliance with GLP, 0.5 ml undiluted test substance was applied to one intact site of each animal (three New Zealand white rabbits), and the site was covered with porous gauze and then wrapped in a semi-occlusive cotton bandage (Dow Corning Corporation, 1993a). After a 4-hour exposure period the application site was washed with tap water. Skin reactions were scored at 1, 24, 48 and 72 hours and 7 days. No irritation was noted after 1 hour. Erythema was observed in 2/3 animals, at 24, 48 and 72 hours. All signs of irritation had reversed by day 7. The third animal showed no signs of irritation throughout the study. The primary dermal irritation score was calculated to be 1.22, and overall the conclusion was that the test substance was minimally irritating to the skin of rabbits, but not sufficient for classification.

There are no eye irritation studies for N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine, therefore good quality reliable data have been read across from the structurally-related substance, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3).

In the key eye irritation study, which was conducted according to OECD Test Guideline 405 and in compliance with GLP, 1,1,1,3,3,3-hexamethyldisilazane was not irritating to rabbit eyes (Dow Corning Corporation, 1993b). Following single instillation of undiluted test material into the eyes of three rabbits, a very slight immediate pain response was observed in all animals. The test material caused slight conjunctival hyperaemia in two animals and slight conjunctival chemosis in one animal at the 1-hour reading. These reactions had subsided at the subsequent readings (2 and 24 hours). The cornea, iris, conjunctivae and chemosis readings for all the animals were 0 at 24, 48 and 72 hours.

Justification for classification or non-classification

Based on the available measured and read-across data, N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine is not classified for skin or eye irritation according to Regulation (EC) No 1272/2008.