Registration Dossier
Registration Dossier
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EC number: 256-905-8 | CAS number: 51000-52-3
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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