3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane

Endpoint summary

Description of key information

The key in vivo study for skin irritation found the registered substance 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane not irritating to the skin of rabbits in a 4-hour occlusive study, conducted according to current OECD Test Guideline 404 and in compliance with GLP (NOTOX, 2011b).

The key in vivo study for eye irritation found the registered substance 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD Test Guideline 405 and in compliance with GLP (NOTOX, 2011c).

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: minimum 2 kg
- Housing: individually housed in cages with perforated floors and shelters
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.1
- Humidity (%): 43-88
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Skin reactions were assessed at ca. 1, 24, 48 and 72 hours after the removal of the dressing and test substance

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: The test substance was applied to the skin of one flank using a metalline patch, which was mounted on micropore tape, which was wrapped around the abdomen and secured with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): YES
- Time after start of exposure: 4 HOURS

SCORING SYSTEM: Similar to Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of 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:

No erythema or oedema were observed in any of the test animals at any of the scoring intervals (1, 24, 48 and 72 hours) following a 4-hour exposure to the test substance. No staining of the treated skin by the test substance was observed and no test substance remnants were seen.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was found not irritating to the skin of rabbits in a 4 hour occlusive study, conducted according to current OECD Test Guideline 404 and in compliance with GLP.

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:

15 August 2011 - 29 August 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING: The study was not conducted for REACH purposes, but according to Article No 25 of Regulation EC No 1272/2008, it has been used to fulfil data gap for eye irritation.

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:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: minimum 2 kg
- Housing: individually housed in cages with perforated floors and shelters
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.1
- Humidity (%): 43-88
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

no

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):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

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

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

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:

0.23

Max. score:

3

Reversibility:

fully reversible

Remarks:

within 48 hours

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:

Instillation of the test material into one eye of each animal resulted in irritation of the conjunctivae, which consisted of redness and discharge in two animals. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other animal. The mean Draize score at 1 hour post instillation was 2.7; at 24 hours post instillation it was 0.7 and at 48 and 72 hours post instillation it was 0.

Other effects:

No staining of ocular or peri-ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was found not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD Test Guideline 405 and in compliance with GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key in vivo study for skin irritation found the registered substance 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane not irritating to the skin of rabbits in a 4-hour occlusive study, conducted according to current OECD Test Guideline 404 and in compliance with GLP (NOTOX, 2011b). No erythema or oedema were observed in any of the test animals at any of the scoring intervals (1, 24, 48 and 72 hours) following a 4-hour exposure to the test substance. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

The key in vivo study for eye irritation found the registered substance 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD Test Guideline 405 and in compliance with GLP (NOTOX, 2011c). Instillation of the test material into one eye of each animal resulted in irritation of the conjunctivae, which consisted of redness and discharge in two animals. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other animal. The mean Draize score at 1 hour post instillation was 2.7; at 24 hours post instillation it was 0.7 and at 48 and 72 hours post instillation it was 0. No staining of ocular or peri-ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Justification for classification or non-classification

Based on the available information, no classification is required for skin or eye irritation for 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane in accordance with Regulation (EC) No 1272/2008.