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Description of key information

No in vitro skin sensitisation tests were performed with the test item because the available in vitro test methods are not applicable for the substance. The test item is not soluble in any solvents listed for the LuSens or h-CLAT test. The DPRA test was not conducted because it is not a stand-alone test. Therefore, two in silico tools (OECD QSAR Toolbox, Toxtree) were used to identify alerts for skin sensitisation potential for the three constituents of the test item.

No skin sensitisation reactivity domain alerts were identified by Toxtree and no protein binding alerts were identified by QSAR Toolbox for none of the three constituents. Therefore, it can be concluded that there is no indication for a skin sensitizing potential of the test item.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Profilers:
General Mechanistic
Protein binding potency GSH
Protein binding by OECD
Protein binding by OASIS
Protein binding potency Cys (DPRA 13%)
Protein binding potency Lys (DPRA 13%)

Endpoint Specific
Protein binding alerts for skin sensitization according to GHS
Protein Binding Potency h-CLAT
Protein binding alerts for Chromosomal aberration by OASIS
Protein binding alerts for skin sensitization by OASIS
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No protein binding alerts were identified for the constituent 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane.
Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Profilers:
General Mechanistic
Protein binding potency GSH
Protein binding by OECD
Protein binding by OASIS
Protein binding potency Cys (DPRA 13%)
Protein binding potency Lys (DPRA 13%)

Endpoint Specific
Protein binding alerts for skin sensitization according to GHS
Protein Binding Potency h-CLAT
Protein binding alerts for Chromosomal aberration by OASIS
Protein binding alerts for skin sensitization by OASIS
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No protein binding alerts were identified for the constituent 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane.
Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Profilers:
General Mechanistic
Protein binding potency GSH
Protein binding by OECD
Protein binding by OASIS
Protein binding potency Cys (DPRA 13%)
Protein binding potency Lys (DPRA 13%)

Endpoint Specific
Protein binding alerts for skin sensitization according to GHS
Protein Binding Potency h-CLAT
Protein binding alerts for Chromosomal aberration by OASIS
Protein binding alerts for skin sensitization by OASIS
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No protein binding alerts were identified for the constituent 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane
Endpoint:
skin sensitisation: in vitro
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Toxtree Module: Skin sensitisation reactivity domains
Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.

Reference: Enoch SJ, Madden JC, Cronin MT,Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.,SAR QSAR Environ Res. 2008;19(5-6):555-78.

Includes alerts for:
QSNAR.SNAr-Nucleophilic Aromatic Substitution 
QSB.Schiff Base Formation 
QMA.Michael Acceptor 
Qacyl.Acyl Transfer Agents 
QSN2.SN2-Nucleophilic Aliphatic Substitution 
Q6.At least one alert for skin sensitisation? 
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No skin sensitisation reactivity domains alerts were identified for the constituent 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane
Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Toxtree Module: Skin sensitisation reactivity domains
Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.

Reference: Enoch SJ, Madden JC, Cronin MT,Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.,SAR QSAR Environ Res. 2008;19(5-6):555-78.

Includes alerts for:
QSNAR.SNAr-Nucleophilic Aromatic Substitution 
QSB.Schiff Base Formation 
QMA.Michael Acceptor 
Qacyl.Acyl Transfer Agents 
QSN2.SN2-Nucleophilic Aliphatic Substitution 
Q6.At least one alert for skin sensitisation? 
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No skin sensitisation reactivity domains alerts were identified for the constituent 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane
Endpoint:
skin sensitisation: in vitro
Type of information:
other: in silico tool
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Toxtree Module: Skin sensitisation reactivity domains
Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.

Reference: Enoch SJ, Madden JC, Cronin MT,Identification of mechanisms of toxic action for skin sensitisation using a SMARTS pattern based approach.,SAR QSAR Environ Res. 2008;19(5-6):555-78.

Includes alerts for:
QSNAR.SNAr-Nucleophilic Aromatic Substitution 
QSB.Schiff Base Formation 
QMA.Michael Acceptor 
Qacyl.Acyl Transfer Agents 
QSN2.SN2-Nucleophilic Aliphatic Substitution 
Q6.At least one alert for skin sensitisation? 
Type of study:
other: in silico tool
Key result
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No skin sensitisation reactivity domains alerts were identified for the constituent 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification