Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime

Endpoint summary

Description of key information

Skin irritation / corrotion: Weight of evidence: Based on the read-across from two experimental studies (in-vivo skin irritation test with GLP) on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime, the read-across was applied and butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be non-irritant for skin of rabbits.

Eye irritation: Key study: Based on the read-across approach from experimental results (in-vivo eye irritation test with GLP) on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime, the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be irritant to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime which shares the same functional group with butan-2-one O,O',O'',O'''-silanetetrayltetraoxime, also has comparable values for the relevant molecular properties for skin irritation/corrosion.
See attached reporting format.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: (Erythema (Grade 1) in 2 of 6 animals. No further observations of erythema) (Results based on read-across from an analogue)

Irritation parameter:

edema score

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: (Results based on read-across from an analogue)

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the read-across approach from experimental results on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime, the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be non irritant to skin of rabbits.

Executive summary:

An in-vivo skin irritaion test was performed on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime according to GLP. Mild, transient erythema was replaced by desquamation that remained in some animals the end of the short observation period (72 h). There was no oedema evident at any time point. The analogue substance was determined to be non-irritant for skin of rabbits. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be non irritant to skin of rabbits.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime which shares the same functional group with butan-2-one O,O',O'',O'''-silanetetrayltetraoxime, also has comparable values for the relevant molecular properties for skin irritation/corrosion.
See attached reporting format.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0.5

Max. score:

8

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: (Results based on read-across from an analogue)

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 48 h

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the read-across approach from experimental results on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime, the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be non irritant to skin of rabbits.

Executive summary:

An in-vivo skin irritaion test was performed on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime according to GLP. Transient effects to rabbit skin from 24-h occluded contact with the test material were observed. These effects were fully reversible within 48 h and thus the test substance was considered not to be irritant to the skin. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be non irritant to 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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime which shares the same functional group with butan-2-one O,O',O'',O'''-silanetetrayltetraoxime, also has comparable values for the relevant molecular properties for eye irritation/corrosion.
See attached reporting format.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: (Results based on read-across from an analogue)

Irritation parameter:

iris score

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: (Results based on read-across from an analogue)

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: (Results based on read-across from an analogue)

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(out of all 6 animals)

Time point:

24/48/72 h

Score:

0.16

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: (Results based on read-across fron an analogue)

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the read-across approach from experimental results on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime, the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be irritant to the eyes of rabbits.

Executive summary:

An eye irritation/corrosion study was performed on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime in a similar manner of OECD 405 and with GLP. The analogue substance was irritating to the eyes of rabbits since 4/6 animals had a mean (24, 48 and 72 hour) score ≥1 for corneal effects. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be irritant to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / Corrosion: Read-across from experimental data on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime:

Weight of evidence: An in-vivo skin irritaion test was performed on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime according to GLP. Transient effects to rabbit skin from 24-h occluded contact were observed. These effects were fully reversible within 48 h and thus the test substance was considered not to be irritant to the skin. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be non-irritant to skin of rabbits.

Weight of evidence: An in-vivo skin irritaion test was performed on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime according to GLP. Mild, transient erythema was replaced by desquamation that remained in some animals at the end of the short observation period (72 h). There was no oedema evident at any time point. The analogue substance was determined to be non-irritant for skin of rabbits. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be non irritant to skin of rabbits.

Eye irritation:Read-across from experimental data on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime:

Key study: An eye irritation/corrosion study was performed on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime in a similar manner of OECD 405 and with GLP. The analogue substance was irritating to the eyes of rabbits since 4/6 animals had a mean (24, 48 and 72 hour) score ≥1 for corneal effects. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be irritant to the eyes of rabbits.

Justification for selection of skin irritation / corrosion endpoint:

Weight of evident approach. Two studies are available with Klimisch score of two.

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 Irritating to eyes (category 2) according to CLP Regulation (EC) No 1272/2008 (cornea score >1, reversible effects).