Registration Dossier
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EC number: 214-353-5 | CAS number: 1122-58-3
Endpoint summary
Administrative data
Description of key information
The NOAEL for a 26 week repeated dose toxicity study of a structural analogue, 4AP, in rats is 1 mg/kg bw/d in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- adequate
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Toxicity hazard data is available for 4 -aminopyridine (4AP) as a structural analogue of DMAP, and is provided in summary form by the European Medicines Agency (EMEA), 2011. All studies were performed according to ICH guidelines and GLP, and so have a Klimisch validity score of 1. In a 26 week subchronic study in rats by the dietary route, chosen by EMEA as the pivotal study, the NOAEL is given as < 2 mg/kg bw/d due to lack of body weight gain. Effects of higher doses involved CNS effects such as tremor, convulsions, ataxia, decreased activity, increased respiratory rate and labored breathing; kidney and urinary tract obstruction, and decreased body weight. A NOAEL of 1.0 mg/kg bw/d is chosen for the point of departure for calculation of the DNEL. This is an arbitrary choice for a NOAEL of less than 2 mg/kg bw/d, sufficiently precautionary, which is consistent with other conclusions of EMEA in their review of 4AP.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
experimental result on a structural analogue
Justification for classification or non-classification
The repeated dose toxicity findings of the analogue, 4AP, do not meet the criteria for STOT-RE in Regulation EC No. 1272/2008.
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