Registration Dossier
Registration Dossier
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EC number: 805-733-7 | CAS number: 256504-39-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In silico assessments on the mutagenic potential using (Q)SAR methologies according to ICH M7 Guideline are accepted in the pharmaceutical context by regulators as valid tools for detecting DNA reactive substances (ICH=International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; M7 Guideline is on "Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk").
Non-GLP Report Dec 4, 2019 (Wichard):
Aminopyrazole was predicted to be positive in DEREK based on the primary aromatic amine (Aromatic amine or amide #353). In agreement, the positive Leadscope prediction is based on the aromatic amine moiety. A VITIC query yielded positive Ames test data for Aminopyrazole (source: BHC report 40578, 2014.)
Justification for classification or non-classification
In addition to the bacterial reverse mutation test data (Ames test) an in silico prediction was performed. With regard to the prediction models used (Leadscope, DEREK, VITIC) the substance raised a strong structural alert for mutagenicity: positive prediction in DEREK, Leadscope and VITIC [Dec 2019].
Data lacking - without further data, a mutagenic potential cannot be excluded for the substance
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