Registration Dossier

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Considering the chemical structure of the organic components and/or ligands of the metal-complexes composing the UVCB substance under registration, with several nitroaromatic (NO2-Ar) groups, an Ames test may not be predictive of genotoxicity in mammalian systems (Kirkland et al., 2007) and the related metabolic pathway is unlikely to be relevant for humans (Kirkland et al., 2014).

Currently, the assessment of the genotoxic potential of the substance under registration is inconclusive; in order to trace the most reliable as possible genotoxic profile, deeper investigations, even involving structural analogues and in vivo experiments would be required. Different tests are in progress or planned on other metal-complexes, but now it is not possible to establish a common mechanism/adverse pathway leading to a definitive conclusion on the assessment of genotoxic potential. The dossier will be promptly updated when reliable and pertinent results for the substance will be available.

Link to relevant study records
in vitro gene mutation study in bacteria
Type of information:
other: Expert Judgement
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data derived from expert judgement
Principles of method if other than guideline:
Expert Judgement
GLP compliance:
not required, data derived from expert Judgement
Type of assay:
bacterial reverse mutation assay
other: expected to be positive
data derived from expert Judgement
Remarks on result:
not measured/tested
Assessment derived from substance review and handbook with collection of data.
Expected to be positive
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification