Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Only few data are available.

No specific data are available on toxicity to reproduction, but the data available on repeated dose toxicity studies indicated no effects on reproductive organs.

 


Short description of key information:
Only few data are available.
No specific data are available on toxicity to reproduction, but the data available on repeated dose toxicity studies indicated no effects on reproductive organs.

Effects on developmental toxicity

Additional information

Three teratogenicity studies were available on different species (mouse, chicken, rat). Two of them were considered as validity 3 according to Klimish scale. These studies were considered as validity 3, because of the poor detail information on material and methods and results, furthermore they did not follow the recognised OECD guidelines. However, the results were similar and indicated no teratogen effects. The study on rat (Vollmuth, 1990) is also poorly described but had been evaluated by EFSA (European Food Safety Authority) and hence was considered as validity 2. It did not follow an OECD guideline but could be considered as teratogen study.

10 female rats per group were exposed one week before mating until 4 days post partum to 0, 125, 250, 500 mg/kg bw/day of Vanillin. Maternal toxicity had been reported with only few details: death, clinical signs and change in body weight and feed consumption. The NOAEL maternal was consider to be 250 mg/kg bw. No effect on pups were reported and the NOEL for teratogenicity was the highest dose tested 500 mg/kg bw.

The “weight of evidence” approach permit to consider that Vanillin had no teratogen properties.

Justification for classification or non-classification

Regarding all the available and according toclassification criteria of EC regulation 1272/2008 Vanillin should not be classified for reprotoxicity.