Registration Dossier
Registration Dossier
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EC number: 266-235-8 | CAS number: 66204-44-2
Neurotoxicity
Administrative data
Description of key information
In a 90-Day subchronic gavage study according to OECD guideline 408 (Leuschner 2002) the test substance induced mainly local effects in the stomach at a dose level of ≥ 60 mg/kg bw. In the functional observation battery no effects were observed.
Key value for chemical safety assessment
Additional information
No study for an assessment of neurotoxicity or delayed neurotoxicity was performed with the substance “ reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)”. Such a study is not considered relevant and thus scientifically unjustified as the substance is not a cholinesterase inhibitor nor a delayed neurotoxicity inducing compound, such as, e.g., some organophosphorus esters are. The chemical structure of the substance does not suggest that it would cause delayed neurotoxicity. Functional Observational Battery Tests as performed in the repeated and subchronic toxicity studies, such as - neurobehavioral observation (detailed clinical observation) - sensorimotor measurements - grip strength - motor activity did not reveal signs indicative for neurotoxic effects. Therefore special tests for the induction of possible neurotoxicity should be waived.
Justification for classification or non-classification
No classifiation required due to the lack of indication for neurotoxic effects.
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