Registration Dossier

Administrative data

Description of key information

The study is currently ongoing.  This  submisison allows co-registrants to register for the deadline and the lead dossier will be spntaneously updated as soon as the result is available. The skin sensitisation has been assessed by assessment of the structure for structural alerts compared to known alerts contained in the DEREK Nexus database. On the basis of the structure the substance is considered non-sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
In silico assessment
Type of information:
calculation (if not (Q)SAR)
Remarks:
The study is currently ongoing. This submisison allows co-registrants to register for the deadline and the lead dossier will be spntaneously updated as soon as the result is available.
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Principles of method if other than guideline:
Assessment of structural alerts undertaken using the DEREK Nexus in silico assessment system.
GLP compliance:
no
Type of study:
other: DEREK Nexus
Details on study design:
Knowledge base version: Derek KB 2015 2.0
Species: Escherichia coli, Salmonella typhimurium, bacterium, dog, guinea pig, hamster, human, mammal, monkey, mouse, primate, rabbit, rat and rodent
Endpoints searched: Skin sensitisation, Irritation.
Processing constraints: The option to perceive tautomers was selected.
Key result
Run / experiment:
DEREK Nexus
Value:
0
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
not examined
Remarks on result:
no indication of skin sensitisation
Other effects / acceptance of results:
No alerts triggered for skin sensitisation. Structure contains no misclassified or unclassified skin sensitisation features – deemed to be NON-SENSITISER.
Interpretation of results:
GHS criteria not met
Conclusions:
The Substance contains no struictural alerts and is considered to be non-sensitising.
Executive summary:

The study is currently ongoing.  This  submisison allows co-registrants to register for the deadline and the lead dossier will be spntaneously updated as soon as the result is available. The skin sensitisation has been assessed by assessment of the structure for structural alerts compared to known alerts contained in the DEREK Nexus database. On the basis of the structure the substance is considered non-sensitising.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification