Registration Dossier
Registration Dossier
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EC number: 221-343-4 | CAS number: 3071-73-6
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:
- 2020
- 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 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
- EC Number:
- 221-343-4
- EC Name:
- Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
- Cas Number:
- 3071-73-6
- Molecular formula:
- C36H25N5O6S2.2Na
- IUPAC Name:
- disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
Constituent 1
- Specific details on test material used for the study:
- Target compound is Acid Black 24, CAS 3071-73-6, EC 221-343-4, formula C36 H23 N5 Na2 O6 S2
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:
- Suspected mutagen , there are three generated amines after the cleavage of the azo bond; one is predicted mutagen, another is non-mutagenic, and one is not predicted.
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