Registration Dossier

Administrative data

Description of key information

Skin irritation / corrotion: Key study: Test method according to OECD 404 and GLP.  Butan-2-one O,O',O''-(vinylsilanetriyl)oxime was determined to be non-irritant to the skin of rabbits.

Eye irritation: Key study: Test method according to OECD 405 and GLP.  Butan-2-one O,O',O''-(vinylsilanetriyl)oxime was determined to be irritating to the eyes of rabbits.

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:
19 Nov 1986 - 22 Nov 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to an appropriate OECD test guideline with acceptable restrictions. The restriction was a shorter observation time (reversibility of effects not fully assessable) than stated in the guideline.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
shorter observation period than specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Saint Aubin les Elbeuf, 76410 Cleon, France
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individually, in polystyrene cages
- Diet: rabbit complete pelleted maintenance food (U.A.R. formula "112", U.A.R., Villemoisson Sur Orge, 91360 Epinay Sur Orge, France), ad libitum
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: 100%
Duration of treatment / exposure:
4 h
Observation period:
72 h (the protocol describes examinations up to 14 days, but no observations are reported later than 72 h)
Reading time points: 1, 24, 48, 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Covered with a Codex hydrophilic eight layer gauze patch kept in contact with the skin by a wide perforated tape applied on a crimped gauze bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: After 4 hours the bandage was removed.

SCORING SYSTEM: Draize scheme
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/1/1/1/1/1

0/0/0/0/0/0

24 h

0/1/1/1/1/1

0/0/0/0/0/0

48 h

0/0/1/1/1/1

0/0/0/0/0/0

72 h

0/0d/1d/1d/1d/1d

0/0/0/0/0/0

Average 24h, 48h, 72h

0.7

0

Reversibility by 72 h*

n

-

* Reversibility: c = completely reversible; n.c.= not completely reversible; n = not reversible

d = desquamation

 

Interpretation of results:
other: Non irritating (according to CLP regulation)
Conclusions:
A reliable study conducted broadly in accordance with OECD 404 and GLP, found the test material to be non- irritating to the skin of rabbits. Mild erythema remained in some animals the end of the short observation period (72 h), but no oedema was reported at any time point.
Executive summary:

An acute dermal irritation/corrosion test was conducted in accordance with OECD 404 and GLP. The substance butan-2-one O,O',O''-(vinylsilanetriyl)oxime was found to be non-irritating to the skin of rabbits. Mild erythema (score of 0.7, mean 24 -72, 6 animals) remained in some animals at the end of the short observation period (72 h) but no oedemas was observed (score of 0).

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:
20 Nov 1986 - 23 Nov 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
shorter observation time than specified
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: No data
- Weight at study initiation: 2.5 kg
- Housing: Individual in polystyrene cages
- Diet: Rabbit complete pelleted maintenance food (UAR formula "112", UAR, Villemoisson sur Orge, 91360 Epinay sur Orge), ad libitum
- Water: Softened and filtered drinking water, ad libitum
- Acclimation period: Minimum one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20.11.1986 To: 23.11.1986
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye is used as the control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
Single adminstration without washing.
Observation period (in vivo):
72 h (the protocol describes examinations up to 21 days but no observations are reported after 72 h)
Reading time points: 1, 24, 48, and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize scoring scheme

TOOL USED TO ASSESS SCORE: direct ophthalmoscopy / fluorescein
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
2.06
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1.83
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1.78
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Other effects:
Corneal ulceration was observed in 5/6 animals up to 72 h. In 1/6 animals corneal ulceration was observed at 1 h and was reversible within 24 h. Circumcorneal injections were observed in all animals up to 72 h. In addition congestion of the iris was observed in 2/6 (48 h) and 3/6 (72 h) animals. Permanent myosis was observed in 4/6, 3/6, 3/6, and 2/6 animals at 1, 24, 48, and 72 h, respectively.

Table 1: Individual scores (1 -72 h) of the eye irritation study in rabbits.

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

swelling

1

1

2

3

1

2

24

2

2

1

2

48

2

2

1

2

72

2

1

1

2

average

2,0

1,7

1,0

2,0

2

1

2

3

1

2

24

2

3

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,3

1,0

2,0

3

1

1

3

1

2

24

2

2

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,0

1,0

2,0

4

1

1

3

1

2

24

1

2

1

2

48

1

1

1

0

72

1

1

1

0

average

1,0

1,3

1,0

0,7

5

1

1

3

1

2

24

2

3

1

2

48

2

3

1

2

72

2

2

1

2

average

2,0

2,7

1,0

2,0

6

1

2

3

1

2

24

2

3

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,3

1,0

2,0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average
score

1

1,50

3,00

1,00

2,00

24

1,83

2,50

1,00

2,00

48

1,83

2,00

1,00

1,67

72

1,83

1,67

1,00

1,67

24+48+72

1,83

2,06

1,00

1,78

Interpretation of results:
other: Irritating (according to CLP regulation)
Conclusions:
A generally reliable study, conducted according to OECD 405 and GLP but with shorter observation than required, reported that the neat test material caused significant irritation to the conjunctiva, iris and cornea of rabbits which remained at the end of the 72-h observation period.

Executive summary:

An acute eye irritation/corrosion test was performed in accordance with OECD 405 and GLP. Test item butan-2-one O,O',O''-(vinylsilanetriyl)oxime caused significant irritation to the conjunctiva, iris and cornea of rabbits which remained at the end of the 72-h observation period.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / Corrosion:

Key study: An acute dermal irritation/corrosion tes was conducted in accordance with OECD 404 and GLP. The substance butan-2-one O,O',O''-(vinylsilanetriyl)oxime was found to be non-irritating to the skin of rabbits. Mild erythema (score of 0.7, mean 24 -72, 6 animals) remained in some animals at the end of the short observation period (72 h) but no oedemas was observed (score of 0).

Eye irritation:

Key study: An acute eye irritation/corrosion test was performed in accordance with OECD 405 and GLP. Test item butan-2-one O,O',O''-(vinylsilanetriyl)oxime caused significant irritation to the conjunctiva, iris and cornea of rabbits which remained at the end of the 72-h observation period.

Justification for selection of skin irritation / corrosion endpoint:

Only one study is available.

Justification for selection of eye irritation endpoint:

Only one study is available.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation: Based on the available data, the substance is not classified as irritating according to CLP Regulation (EC) No 1272/2008.

Eye irritation: Based on the available data, the substance is classified as Serious Eye Damage (Category 1) according to CLP Regulation (EC) No 1272/2008 (cornea >1, iritis >1, redness >2, chemosis >2, reversibility not assessed).