Registration Dossier

Administrative data

Description of key information

Rats were exposed to nominal concentrations of Vinyl Neodeconoate of: 0. 0.25, 0.50 and 1.0 gm/m3 for 6 hr/day for 90 days by vapor inhalation.   Significant adverse findings were: reduced male body weight gain at 1.0 gm/m3; elevated female liver weight at 0.50 and 1.0 gm/m3; elevated male rat liver and kidney weights at 1.0 gm/m3 and elevated male serum alkaline phosphatase at 1.0 gm/m3.  No adverse histopathological findings were made.  
In a rat O.E.C.D. 422 28-day oral gavage study the dose levels were: 0, 100, 250 and 1000 mg.kg/day. No adverse findings were made for female rats at any dose level. Male rats had significantly elevated liver weights relative to the control at 250 and 1000 mg/kg. However, this finding is concidered to be due to an adapative metabolic response to test substance. No abnormal histopathological findings were made male rat liver sections. Male rat blood urea nitrogen (BUN) was significantely increased at 1000 mg/kg. Histopathological examination found male rat kidney nephropathy and accumulation of alpha-2-u-microglobin only at the high dose. These findings are indicative of male rat specific nephropathy that is not relevant to human health.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
500 mg/m³

Additional information

The 90-day rat inhalation study is the most appropriate study for estimatining a systemic effect long-term Worker and General Population DNEL for Vinyl Neodeconoate. The NOAEC for this study based on male rat weight decrement, increased liver and kidney weights and alkaline phosphatase levels at the high dose is 500 mg/m3 or approimately 62 ppm.

Little or no worker dermal exposure is expected based on the use of standard safety practices, process and engineering controls. Consumers are not believed to be exposed to Vinyl Neodeconoate.


Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Repeated dose toxicity: inhalation - systemic effects (target organ) digestive: liver; urogenital: kidneys

Justification for classification or non-classification

Criteria of EU Directive 67/548/EEC and the CLP (Directive 1272/2008) for systemic target organ Classification and Labeling were not met by Vinyl Neodeconoate.