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We provide toxicology services for the agro-chemical industry, more commonly referred by sponsors in industry parlance as 6-pack studies.

6-pack studies
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization

Article 13(3) of the REACH Regulation requires that new tests shall be carried out in accordance with the test guidelines included in Commission Regulation No. 440/2008 or in accordance with other international test methods recognized by the European Commission or ECHA. In addition, in Annexes VII to X on standard information requirements, the use of various OECD test guidelines is required in cases where no EU test method exists (e.g. OECD TG 414, 421 and 422).

Article 13(3) also specifies that information may be generated using other methods, provided the conditions defined in Annex XI of the REACH Regulation are met. These include that the result is sufficient for the purposes of classification and labeling and/or risk assessment, and that adequate and reliable documentation of the applied method is provided (see Annex XI of the REACH Regulation for more information).

Moreover, a specific requirement is introduced in Article 13(4) of the REACH Regulation for ecotoxicological and toxicological tests. Since 1, June 2008, new tests of this kind have to be carried out in compliance with the principles of Good Laboratory Practice (GLP) provided for in Directive 2004/10/EC, as no other international standard has so far been recognized as being equivalent. In case of physico-chemical testing it may be desirable but it is not mandatory to have tests performed according to GLP standard.

The Guidance on information requirements and chemical safety assessment contains specific Integrated Testing Strategies for each endpoint (e.g. for aquatic toxicity, mutagenicity), which should be consulted before new tests are performed.

Vanta Bioscience performs the following in vivo and in vitro studies required to fulfill the REACH requirements as indicated below:

Sensitization test
Acute toxicity oral
Mutagenicity (Ames test)
Repeated dose toxicity (28 d, 90 d and 12 month)
In vivo skin / eye irritation
Acute toxicity (dermal, inhalation, oral)
Acute neurotoxicity
Mutagenicity (in vitro gene mutation – mammalian cells)
Development and reproductive toxicity (Seg I, II & III)
Toxicokinetics assessment
Carcinogenicity study

A test battery consisting of analytical, ecotoxicity,in vivo and in vitro toxicology studies is required to obtain approval from the CIB (Central Insecticide Board), Ministry of Agriculture, Govt. of India for import, manufacture and sale or export, as the case maybe. Guidelines have been established for each end usage under the Insecticides Act.