Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Read across from vinyl neononanoate will be used to fill the 2-generattion reproductive toxicity end point when the test plan for vinyl neononanoate has been approved and completed. 

Supporting data from an OECD 422 combined repeated-dose, developmental/reproductive toxicity study on vinyl neodecanoate is read across to vinyl 2-ethylhexanoate as weight of evidence. Vinyl Neodecanoate was evaluated by the oral gavage route of administration. Based on the findings from this study Vinyl Neodecanoate is not a reproductive toxicant or developmental in laboratory rats. The NOAEL for adult animals and reproductive/developmental effects was the high dose of 1000 mg/kg/day.


Short description of key information:
It is intended that data will be read across from vinyl neononanoate to vinyl 2-ethylhexanoate.
A waiver under REACH Annex XI 1.5 is being claimed based upon a “similarity” of “(1) a common functional group” as stated in the Legislation.
It is intended that read across from vinyl neononanoate will be used to fill the 2-generation reproductive end point after the test plan for vinyl neononanoate has been approved and the testing completed. The results of this testing will be evaluated in conjunction with existing data for this substance, and read-across will be applied to vinyl 2-ethyl hexanoic acid if the 90 day study data is not inconsistent with existing results for a 14 day repeated dose study on this Registered substance
Supporting data from an OECD 422 combined repeated-dose, developmental/reproductive toxicity study on vinyl neodecanoate is read across to vinyl 2-ethylhexanoate as weight of evidence.

Effects on developmental toxicity

Description of key information
Vinyl 2-ethylhexanoate showed developmental toxicity in rats at 750 mg/kg/day with an NOAEL of 350 mg/kg/day.  In a developmental toxicity study in rabbits a maternal toxicity was observed in one rabbit at 350 mg/kg/day with a NOAEL at 100 mg/kg/day
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
350 mg/kg bw/day
Additional information

Vinyl 2 -ethylhexanoate is a developmental toxicant in rats in the absence of maternal toxicity causing a slight increase in the external malformation filamentous tail together with various skeletal variants, reduced ossification and reduced foetal body weight indicative of developmental retardation. The NOEL for maternal toxicity was 750 mg/kg/day and the NOEL for developmental toxicity was 350 mg/kg/day.

In rabbits vinyl 2 -ethylhexanoate did not cause developmental effects in the absence of maternal toxicity. The 750 mg/kg/day level exceeded the maximum tolerated dose and this precluded a definitive assessment of developmental toxicity at this dose level. TheNOEL for maternal toxicity was 100 mg/kg/day and the NOAEL for developmental toxicity was 350 mg/kg/day.

Justification for classification or non-classification

Additional information