Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genotoxicity in vitro:

Thirty seven studies of validity 2 (published data and reports) were reported in different endpoint study records. Some of them concern in vitro mutation studies in bacteria or mammalian cells, other concern chromosomal aberration studies, with and without metabolic activation system.

Concerning gene mutations, the study report ofHazleton(1991) was selected as key study. This study was conducted according to OECD 471 guideline. The study report of Marzin (1979), as well as published data from Mortelmans (1988), Pool (1982), Ishidate (1984) and Kasamaki (1982) were selected as supporting studies. All these studies were performed with acceptable scientific principles and support the negative results obtained with the key study.

Concerning chromosomal aberrations, the study report ofHazleton(1991) was chosen as key study. The study followed the OECD 473 guideline and was negative.

Other studies reported deal with the antimutagenic effect of Vanillin in gene mutations (Ohta 1986, Watanabe 1988, Sasaki 1987, De Flora 1994), in chromosomal aberrations (Sasaki 1990, Keshava 1997, Tamai 1992) or in micronucleus in vitro on CHO or CHL cells (Keshava 1998). These studies were well conducted and had the validity 2 or 3 according to Klimish.

Ambiguous and some positive results observed in published data were not considered valid because they were not conducted according to recognized guidelines, or were not enough described for assessment. Data concerned sister chromatid exchange and micronucleus in vitro.

CONCLUSION FOR GENOTOXICITY IN VITRO: negative in gene mutations and chromosomal aberrations with and without metabolic activation system.

Genotoxicity in vivo:

One study concerning Vanillin with validity 2 was available and was selected as key study. The summary of this study is the following:

In a OF1 mouse bone marrow micronucleus assay (Marzin, 1979), 10 females per dose were treated by gavage with Vanillin (pure) at doses of 500 and 1000 mg/kg bw.  Bone marrow cells were harvestedat 6and 30 hours post-treatment.  The vehicle was arachid oil.

The positive control induced the appropriate response. 

There wereno signs of toxicityduring the study.

 

Four studies on the antimutagenic effect with validity 2, were available and were well described. All of these studies demonstrated that Vanillin had an antimutagenic effect.

CONCLUSION FOR GENOTOXICITY:thein vitrogenotoxic studies available indicated negative effects in gene mutations and chromosomal aberrations with and without metabolic activation system. Thein vivostudies available on micronucleus assay and antimutagenic effect confirm the absence of genotoxic effect of Vanillin.

All the results available indicated that Vanillin had no effect in genotoxicity studies.According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for genotoxicity.



Short description of key information:
Vanilline showed negative results in in-vitro studies (Ames test, chromosomal aberrations) and in in-vivo studies.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification