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Toxicological information

Genetic toxicity: in vitro

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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:
2021

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
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)
EC Number:
265-016-4
EC Name:
7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)
Cas Number:
64683-40-5
Molecular formula:
C22H17N5O7S2.2C6H15NO3
IUPAC Name:
7-amino-4-hydroxy-3-({4-[(4-sulfophenyl)diazenyl]phenyl}diazenyl)naphthalene-2-sulfonic acid - 2,2',2''-nitrilotriethanol (1:2)

Results and discussion

Remarks on result:
mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
Suspected mutagen (the cleavage produce 3 amines – 1 predicted mutagenic – 2 predicted non mutagenic)