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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: Key study: Based on the read-across approach from experimental data on analogue butan-2-one O,O',O''-(methylsilanetriyl)oxime (guinea-pig maximisation test, GLP study), the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 skin sensitisation.
See attached reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
14
Total no. in group:
14
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 14.0. Total no. in groups: 14.0.
Key result
Reading:
2nd reading
Hours after challenge:
28
Group:
test chemical
Dose level:
50%
No. with + reactions:
14
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 28.0. Group: test group. Dose level: 50%. No with. + reactions: 14.0. Total no. in groups: 15.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
3
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 3.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
48
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 48. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No details given
Interpretation of results:
sensitising
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 read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be skin sensitiser.
Executive summary:

A guinea-pig maximisation test was conducted according to OECD 406 and GLP on the analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime. 15 female guinea pigs were exposed to induction doses of 5% (intradermal) and 25% (epicutaneous) and a challenge dose of 50% test item. Another 3 females were used as negative controls. The results on the analogue reported a response to challenge in 14 of 15 animals at 24 and 48 h. Responses in 1 of 3 and 0 of 3 were reported at 24 and 48 hours, respectively, in the small negative control group. Based on these results, the read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be skin sensitiser since a response of 30% or more in an adjuvant test indicates sensitisation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation:


Key study: A guinea-pig maximisation test was conducted with GLP was performed on analogue substance butan-2-one O,O',O''-(methylsilylidyne)trioxime. The results reported a response to challenge (using 50% test substance) in 14 of 15 animals at 24 and 48 h. Responses in 1 of 3 and 0 of 3 were reported at 24 and 48 hours, respectively, in the small negative control group. A response of 30% or more in an adjuvant test indicates sensitisation. Based on this experimental data, a read-across approach was applied and the substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime was determined to be skin sensitiser.


 


Justification for selection of skin sensitisation endpoint:


Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the test substance butan-2-one O,O',O'',O'''-silanetetrayltetraoxime is classified as Sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008 (>30 responding at >1% intradermal induction dose).