Initial Assessment for Human exposure in Vanillin

Vanillin is a phenolic aldehyde, which is an organic compound with the molecular formula C8H8O3. Its functional groups include aldehyde, ether, and phenol. It is the primary component of the extract of the vanilla bean. Synthetic vanillin, instead of natural vanilla extract, is sometimes used as a flavoring agent in foods, beverages, and pharmaceuticals.The cas no is 121-33-5.

Vanillin occurs widely in plants in the nature, usually as a glycoside bound to sugar or as a precursor to vanillin bound to the large lignin molecule abundant in wood. Free vanillin in the environment will be distributed to the aqueous compartment, and there is no tendency to bioaccumulation. The emission of vanillin from the vanillin production and from consumer products to the environment, is not considered to represent any biohazard. In the previous article,we have talked about the question that how does human expoeure in vanillin. This passage,I will give the Initial Assessment.

In the human health risk assessment the consumer exposure (by oral intake) is taken as the ADI value(10.0 mg/kg/day).

Occupational exposure has been identified as inhalation of vanillin dust by operators in the packaging area of the factory. This exposure has been quantified to a maximum of 0.5 mg/kg/day. This level is likely to never be reached since the amount of vanillin in the total dust is estimated to only about 10 %. Additionally, much less than 1 % of the product has a particle size small enough to reach the lungs.

Skin exposure to vanillin has not been quantified, but both consumers and workers will be subject to aminor extent of suchexposure.

1.Assessment from acute and repeated dose toxicity

From the acute toxicity studies, the LD50 value for rats (3500 - 4000 mg/kg) gives a safety margin of 350-400 for consumers, and this is considered satisfactory. From the oral repeated dose toxicity studies a NOEL of 2500 mg/kg/day was observed after oral feeding to rats. This gives a safety margin of 250 for consumers use, and this is considered acceptable.

2.Assessment from reproduction and development studies

The potential toxicity of vanillin to the reproductive system has been studied in several connections. Microscopic and macroscopic histopathological evaluation of reproductive organs were performed in connection with repeated dose studies. In the mouse spot test and in a study to test the possible antimutagenic effect of vanillin, it was given to pregnant mice. The potential teratogenicity of vanillin has

also been tested in the developing chicken embryo test. There has been no sign of vanillin being toxic to the reproduction system, or to the developing embryo in any of these tests. Even though a reproduction/development study carried out according to OECD-guidelines is lacking, the present use and production of vanillin indicate no such risk.

3.Assessment from genotoxicity and cancer studies

The testing of the potential genotoxicity of vanillin is comprehensive. Mutagenicity testing in bacteria was negative. Testing in vitro in mammalian cells gave positive results in tests for sister chromatid exchange and chromosomal aberration in human lymphocytes. These results indicate that vanillin under certain testing conditions might be genotoxic. However, in vivo genotoxicity tests were negative. An overall evaluation of the test results indicate that vanillin is not likely to pose a genetic risk to humans.

The carcinogenicity studies, including a 2 years study in rats, did all give negative results. It is concludedthat the present use and production of vanillin represent little risk for genotoxicity and there are no signs of carcinogenicity.

4.Assessment from skin irritation and sensitisation testing

Skin irritation and sensitisation testing have shown that in some tests vanillin turned out to be a sensitiser and thus a potential allergen. These results are, however, not conclusive and the negative human datasupport the opinion that vanillin is not a human allergen.

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