Registration Dossier

Administrative data

Description of key information

Vinyl Neodeconoate induced no evidence of neurtoxicity in an O.E.C.D. 422 Testing Guideline oral rat screening study conducted up to a high dose level of 1000 mg/kg/day.  

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Additional information

Vinyl Neodeconoate did not induce signs of neurtoxicity in an O.E.C.D. 422 Testing Guideline oral gavage rat screening study based on the results of a Functional Observational Battery and motor activity assessment. The NOAEL for this endpoint was 1000 mg/kg/day. The Worker Inhalation DNEL based on ECHA RIP 3.2 Chapter R.10 guidance for this endpoint is estimated to be > 1.45 ppm TWA.

Therefore, the Worker long-term Inhalation DNEL derived from the 90 -day rat subchronic inhalation study of 0.6 ppm is considerd to be protective.

Justification for classification or non-classification

Based on the available study data Vinyl Neodeconoate does not meet the criteria for Classification and Labeling as R48 due to neurological findings as established by EU Directive 67/548/EEC Annex 6 and the CLP.