Registration Dossier

Administrative data

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
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.