Iron, complexes with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid monosodium salt coupled with 4-[(2-hydroxy-3,5-dinitrophenyl)azo]-1,3-benzenediol, diazotized 4-nitrobenzenamine and diazotized 3-aminobenzenesulfonic acid monosodium salt

Endpoint summary

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

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: Expert Judgement

Adequacy of study:

weight of evidence

Reliability:

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:

no

Remarks:

not required, data derived from expert Judgement

Type of assay:

bacterial reverse mutation assay

Genotoxicity:

other: expected to be positive

Remarks:

data derived from expert Judgement

Remarks on result:

not measured/tested

Remarks:

Assessment derived from substance review and handbook with collection of data.

Conclusions:

Expected to be positive

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available