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

Endpoint summary

Description of key information

Acute oral toxicity: Key study: Test according to OECD guideline 401. GLP study. LD50 was determined to be 2317.10 mg/kg bw.

Acute dermal toxicity: Key study: Test method according to OECD 402. GLP study. LD50 was determined to be > 2000 mg/kg bw.

Acute inhalation toxicity: Data waiving (other justification): According to REACH Annex VIII, column 2, the study was not needed to be performed since the choice for the second routh in addition for the oral route was provided for dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 acute toxicity.
See attached reporting format.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 282.81 mg/kg bw

Based on:

test mat.

Remarks:

(analogue substance)

Remarks on result:

other: (Method of Bliss) (Based on read-across approach from an anaogue)

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 273.54 mg/kg bw

Based on:

test mat.

Remarks:

(analogue substance)

Remarks on result:

other: (Method of Litchfield & Wilcoxon) (Based on read-across approach from an anlogue)

Interpretation of results:

not classified

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 oral LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be 2282.81 mg/kg bw in rats.

Executive summary:

An acute study was perfomed in accordance with OECD 401 and GLP on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime. The LD50 was determined to be 2463 mg/kg bw. Based on these results the read-across was applied and the oral LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be 2282.81 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 282.81 mg/kg bw

Quality of whole database:

The key study is a GLP compliant and has Klimisch score 1. The quality of the database was determined as appropriate for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 acute toxicity.
See attached reporting format.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Based on:

test mat.

Remarks:

(analogue substance)

Remarks on result:

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

Interpretation of results:

not classified

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 dermal LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be >2000 mg/kg bw in rats.

Executive summary:

An acute dermal toxicity test was perfomed in accordance with OECD 402 and GLP on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime in rats. No effects were observed and the dermal LD50 was determined to be >2000 mg/kg bw. Based on these results, the read-across was applied and the dermal LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be >2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The study is a GLP compliant and has Klimisch score 1. The quality of the database was determined as appropriate for assessment.

Additional information

Acute oral toxicity: Read-across from experimental data on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime:

Key study: An acute study was perfomed in accordance with OECD 401 and GLP on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime were the LD50 was determined to be 2463 mg/kg bw. Based on these results the read-across was applied and the oral LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be 2282.81 mg/kg bw in rats.

Supporting study: An acute oral study was performed with a method similar to OECD Guideline 401 and GLP on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime in rats. The oral LD50 was stimated to be ~ 2500 mg/kg and dose-related anemia was found at all dose levels 14 days after dosing extramedullary hematopoiesis and hemosiderin deposition in the spleen. Based on these results, the read across was applied and the oral LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be 2317.10 mg/kg bw in rats.

Acute dermal toxicity: Read-across from experimental data on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime:

Key study: An acute dermal toxicity test was perfomed in accordance with OECD 402 and GLP on analogue butan-2-one O,O',O''-(methylsilylidyne)trioxime in rats. No effects were observed and the dermal LD50 was determined to be >2000 mg/kg bw. Based on these results, the read-across was applied and the dermal LD50 for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was also determined to be >2000 mg/kg bw in rats.

Acute inhalation toxicity:

Data waingin (other justification): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. This information is provided for dermal route.

Justification for selection of acute toxicity – oral endpoint

The study with highest reliability.

Justification for selection of acute toxicity – inhalation endpoint

According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. This information is provided for dermal route.

Justification for selection of acute toxicity – dermal endpoint

Only one study available.

Justification for classification or non-classification

Based on the available data on oral and dermal acute toxicity (LD50 > 2000 mg/kg bw), the butan-2-one O,O',O'',O'''-silanetetrayltetraoxime is not classified for acute toxicity according to CLP Regulation (EC) No 1272/2008.