Toxicology of Crop Protection Agents

Genotoxicity studies

• Ames test
• In Vitro Chromosomal aberration test in CHO cells
• In Vitro mammalian cell gene mutation test in CHO cells using the Hprt Gene and in Mouse Lymphoma cells using the Tkgene
• In Vitro mammalian micronucleus test in CHO cells
• In Vivo micronucleus test in rats/mice

Toxicology studies (In Vivo)

• Acute 6 pack studies: Oral, Dermal, Inhalation, Dermal irritation / corrosion, Eye irritation/corrosion and Skin sensitization tests
• Dose range finding toxicology studies in rodents (rats/mice)
• Dose range finding toxicology studies in non-rodents
• 28-day repeat dose toxicology studies in rodents (rats/mice)
• 90-day repeat dose toxicology studies in rodents and non-rodents
• 6 to 12 month repeat dose toxicology studies in rodents (rats/mice)
• 6 to 12 month repeat dose toxicology studies in non-rodents
• Carcinogenicity studies in rats/mice
• Combined chronic toxicity and carcinogenicity studies in rats/mice
• Combined repeated dose with reproduction/developmental toxicity screening studies in rats
• Reproduction/developmental toxicity screening studies in rats
• Segment II Developmental Toxicity studies in rodents and rabbits
• 1, 2 and 3 generation reproduction toxicology studies in rats
• Extended one-generation reproductive toxicity studies in rats
• Developmental neurotoxicity studies in rats

• Oral through gavage, dietary or drinking water
• Inhalation
• Ocular
• Dermal

Mavens has a proven track record of executing GLP-compliant toxicity investigations for regulatory submission. Since 1992, when it became the first laboratory in India to receive GLP accreditation from the German Ministry of Health, the development centre has been GLP recognised by the BfR German Health Ministry. W&V Netherlands accredits this facility in 1999, and Indian GLP authorities accredit it in 2005. Since 2001, the facility has also been AAALAC International certified. The facility was also India’s first GLP facility, having been inspected by the US Food and Drug Administration in 2012.

We’ve completed over 7000 GLP studies for regulatory agencies throughout the world, including the USFDA, EMA, MHRA, TGA, Health Canada, and DCGI. Agrochemicals, chemicals (REACH), dyes, and other sectors require a wide range of toxicological studies, which we can provide.

The investigations were conducted in accordance with OECD GLP and study criteria established by international regulatory authorities such as the USFDA, USEPA (OPPTS), OECD, EEC, JMAFF, WHO, DCGI, DBT, and CIB of India, among others.

Our extensive range of GLP and non-GLP service offerings, together with our more than three decades of experience, ensure that we fulfil the current global toxicological testing criteria. Mavens’ skilled team ensures that studies are completed in the quickest time feasible, allowing regulatory submissions to be expedited.

The Institutional Animal Ethics Committee (IAEC), which is comparable to AAALAC International’s IACUC, reviews and approves all animal experimental protocols.

Mavens’ vivarium is one of the largest in South Asia, with over 80 chambers that satisfy international maintenance and operation requirements and is authorised by the CPCSEA, Government of India, and AAALAC International.

Mavens’ development centre has produced comprehensive pesticide registration packages for submission to international regulatory bodies, including the US Environmental Protection Agency. In addition, the company conducts chronic toxicity, reproductive toxicity, juvenile toxicity, and carcinogenicity research on a regular basis. 58 carcinogenicity investigations have been completed at this facility to date, largely for submission to US and EU regulators. Because of the center’s lengthy history, it now possesses a large historical control dataset in rats (Wistar and Sprague Dawley) and mice (Swiss Albino).

In addition to routine carcinogenicity investigations, the company has completed a 6-month carcinogenicity study in the Tg RasH2 transgenic mouse model, a service offered by only a few global nonclinical contract research organisations.

The toxicology team at Mavens takes pride in having 35 highly qualified study directors, each with an average of 15 years of industry and regulatory experience. Mavens also employs nine toxicologists who are qualified by the American Board of Toxicology (DABT).

• Toxicology services for agrochemicals and industrial chemicals are supported by Mavens, which has the appropriate analytical support and equipment.
• Digital Pathology Services.
  • In-house software solutions for statistical analysis and data interpretation that are efficient and well-tested.
  • Clinical symptoms, 
  • body weight, feed intake, haematology and clinical chemistry, histopathology, and tumour incidence have all been studied in the past. Furthermore, historical data is provided for all types of reproduction investigations, such as fertility, pre- and postnatal studies, and genetic toxicological studies.
• IT support to meet client needs.
• An independent Quality Assurance Unit (QAU).