Registration Dossier
Registration Dossier
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EC number: 236-102-9 | CAS number: 13162-05-5
Neurotoxicity
Administrative data
Description of key information
There was no functional or morphological evidence of neurotoxicity in a 90-day repeated dose inhalation study in rats with neurofunctional testing and neuropathology (BASF AG, 1995).
Key value for chemical safety assessment
Additional information
In the key study that was performed according to OECD guideline 413 with additional neurotoxicity testing following EPA test guideline (EPA 1985/87), 15 male and 15 female Wistar rats per test group were exposed to vapors of Vinylformamide (VFA) for 6 hours per working day for 103 days (65 exposures). The target concentrations of treatment groups were 10, 50 and 250 mg/m³ (3,4 ; 17 and 86 ppm). A concurrent control group was exposed to clean air. Clinical examination was performed once each working day during preflow period and on post exposure day (day 103). On exposure days findings were recorded before, during and after exposure. Body weight of the animals was determined weekly. Ophthalmology was carried out prior to and at the end of exposure period. Functional observational batteries and motor activity measurements were performed in 10 animals/sex and test group once before start of the exposure period and three times during the exposure period in about monthly intervals. Hematological and clinicochemical examination of numerous parameters was performed in 10 animals/ sex at the end of exposure period, including GSH and gamma-GT levels in liver homogenate. A complete necropsy including weighing of selected organs and gross pathological evaluation was performed in ten animals per sex. Histopathology was performed on several organs and tissues in these animals as required by the corresponding testing guidelines. Five animals per sex were sacrificed by perfusion fixation. These animals underwent neuropathological examinations. There was no functional or morphological evidence of neurotoxicity (BASF AG, 1995)
Justification for classification or non-classification
GHS classification according to Annex I 1272/2008 CLP (EU GHS):
no classification required
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