Registration Dossier
Registration Dossier
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EC number: 233-439-3 | CAS number: 10169-02-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- QMRF and QPRF are attached.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
- Principles of method if other than guideline:
- Expert system (knowledge-based). See further info attached and reference publication:
Gadaleta, D., Manganelli, S., Manganaro, A., Porta, N., & Benfenati, E. (2016). A knowledge-based expert rule system for predicting mutagenicity (Ames test) of aromatic amines and azo compounds. Toxicology, 370, 20-30.
Test material
- Reference substance name:
- Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate
- EC Number:
- 233-439-3
- EC Name:
- Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate
- Cas Number:
- 10169-02-5
- Molecular formula:
- C32H20N4Na2O8S2
- IUPAC Name:
- NA
Constituent 1
- Specific details on test material used for the study:
- The analyzed azo dye presents one azo bonds that can have a clevage with consequent generation of amine mutagenic products (Øllgaard et al., 1998; Weber and
Adams,1995).
Results and discussion
- Remarks on result:
- ambiguous mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- Overall, the azo compound is predicted as mutagen based on two out of three mutagenic amines released by the azo bond cleavage.
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