Registration Dossier

Administrative data

Description of key information

Based on read across from a structurally related category of compounds, TEMPIC is considered to be a strong sensitizer (Skin Sens 1A)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
see attached category justification
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Parameter:
EC3
Value:
> 2
Test group / Remarks:
read across
Remarks on result:
positive indication of skin sensitisation based on QSAR/QSPR prediction
Parameter:
SI
Value:
4.13
Test group / Remarks:
30% CaTG
Parameter:
SI
Value:
4.83
Test group / Remarks:
25% KTG
Parameter:
SI
Value:
5.89
Test group / Remarks:
25% MeaTG
Parameter:
SI
Value:
6.7
Test group / Remarks:
10% NaTG
Parameter:
SI
Value:
17
Test group / Remarks:
8% ATG
Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Based on the category hypothesis and the presence of three thiol groups, TEMPIC should be classified as Skin Sens 1A.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the category hypothesis and the presence of three thiol groups, TEMPIC should be classified as Skin Sens 1A.