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Description of key information

In a subchronic study by oral route, no effect related to vanillin was observed. The NOAEL determined was 650 mg/kg/day. 
Other studies by dermal and inhalation route were poorly described and were not taken into account for assessment.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
650 mg/kg bw/day

Additional information

8 studies by oral route on rats and mice were available from 16 weeks to 2 years of treatment. Only one of them (Monsanto, 1955) was selected as key study and was with validity 2.

Other available studies were with validity from 2 to 4.

All studies described by Hagan, 1967 (validity 2), in which the time of treatment varied from 16 weeks to 2 years, were selected for a weight of evidence approach, as for the study described by Opdyke (validity 3). Hagans' studies were summarised in WHO technical report 909 published in 2002.

In most of these studies, no effects were observed (body weight, clinical signs, organ weight, histopathology. . .).

The key study has the following summary:

In a subchronic toxicity study (Mosanto, 1955) vanillin (purity unknown) was administered to male Carworth Farms rats, 10/dose, in diet at dose levels of 0, 1000, 5000,10000ppm.No effect related to vanillin was observed.

The NOEL is10000ppm (equivalent to ca. 650 mg/kg bw/d).

One study by dermal route and two studies by inhalation route were available. They were of validity 3, poorly described and were not taken into account for assessment.

All the results available indicated that Vanillin had no effect in oral subchronic toxicity studies.According toclassification criteria of EC regulation 1272/2008 Vanillin should not be classified for repeated exposure.

Justification for classification or non-classification