reprotox

Reproductive Toxicology for Chemical Products: Ensuring Safety and Compliance

Reproductive toxicology is a critical aspect of chemical product development. It involves the study of substances that affect the reproductive system and may cause disorders such as infertility, developmental issues, and birth defects. At Vivotecnia, we offer comprehensive reproductive toxicology services for chemical products, ensuring safety, efficacy, and regulatory compliance.

Understanding Reproductive Toxicology in Chemical Products

Reproductive toxicology studies are designed to identify, characterize, and quantify the potential risks of chemicals to the reproductive health of both males and females. These studies are crucial in assessing the potential effects of substances on fertility, embryonic development, and postnatal development.
Chemicals can sometimes have unanticipated and complex impacts on reproductive capacity and embryonic development. They can affect sexual function and fertility in adult males and females or lead to malformations, developmental retardations, or mortality of the fetus when pregnant women are exposed. Over the past 30 years, our understanding of embryogenesis and mechanisms of developmental toxicity has greatly advanced, as has the regulatory framework of developmental and reproductive toxicology (DART) studies.

Compliance Guidelines in Reproductive Toxicology for Chemical Products

Chemical product development is subject to a range of compliance guidelines that dictate the necessary reproductive toxicology studies. These guidelines are set forth by regulatory bodies such as the European Chemicals Agency (ECHA) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The specific requirements depend on the tonnage per annum (TPA) of the chemical product marketed:

  • Information Requirements at 10 TPA: If there are no serious concerns over reproduction or development, a screening study (OECD421/422) is required. If there are serious concerns about the potential for adverse effects on fertility or development, a prenatal developmental toxicity study or a two-generation or extended one-generation reproductive toxicity study may be proposed instead of the screening study.
  • Information Requirements at 100 TPA: A prenatal developmental toxicity study in one species (usually rat) is required. If the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues, a two-generation or extended one-generation reproductive toxicity study in one species should be conducted.
  • Information Requirements at 1000 TPA: A prenatal developmental toxicity study in one species (usually rat) is required. The need for a second species is judged on a case-by-case basis. A two-generation or extended one-generation reproductive toxicity study in one species is also required, with the need for a second species judged on a case-by-case basis.

Importance of GLP Compliance

Good Laboratory Practice (GLP) is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies. As a GLP-compliant Contract Research Organization (CRO), Vivotecnia ensures that all our reproductive toxicology studies for chemical products are conducted in accordance with these principles. This not only ensures the reliability and integrity of our studies but also facilitates regulatory approval of your chemical products.

Who Needs Reproductive Toxicology Services?

Reproductive toxicology services are essential for any company involved in the development and marketing of chemical products. This includes manufacturers of industrial chemicals, agrochemicals, cosmetics, and more. These services are crucial in ensuring the safety of these products and their compliance with regulatory requirements.

Contact Us Today

At Vivotecnia, we are dedicated to helping our clients ensure the safety and efficacy of their chemical products through comprehensive and reliable reproductive toxicology testing services. If you need assistance with reproductive toxicology testing for your chemical products, contact us today. Our team of experts is ready to assist you with your testing needs.
Ready to ensure the safety and efficacy of your chemical products with comprehensive reproductive toxicology testing? Contact us today to learn more about our services and how we can assist you. Fill out our contact form, and one of our representatives will get back to you as soon as possible.
Remember, at Vivotecnia, your product’s safety is our priority. Let us help you make the world a safer place.

 

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Our team and experience
Vivotecnia offers the high level of scientific expertise needed to address special DART regulatory study requirements, including fertility, developmental toxicity (teratology), juvenile studies and multigenerational reproductive studies. Tests can be performed using a wide selection of administration routes, for example dermal or intravenous infusion. Our designs are customized to individual sponsor’s needs in line with regulatory guidances, including FDA, EMEA, and OECD standards.

At Vivotecnia we are skilled and experienced in assessing all necessary endpoints:

Maternal evaluation

  • Necropsy
  • C-sections
  • Uterine examinations

Post-mortem fetal evaluations in multiple species and strains

  • External morphology
  • Visceral
  • Skeletal

Neurobehavioral assessments

  • Motor activity
  • Learning
  • Memory
  • Acoustic startle response

Sperm evaluation

  • Concentration
  • Count
  • Motility
  • Morphology

General Reprotox

You can trust Vivotecnia to carry out preclinical reproductive toxicology studies which ensure that your product development objectives are met, thereby facilitating product registration.

Reprotox for Pharmaceutical

At Vivotecnia, we offer comprehensive reproductive toxicology services for pharmaceutical products, ensuring safety, efficacy, and regulatory compliance

    CONTACT

    For more information or a formal quotation, please send us a message and we will contact you as soon as possible.


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