reprotox

Reprotox

Chemical Product Testing

 

Our testing solutions ensure the practical implementation of REACH requirements in concert with any additional developmental and reproductive toxicity testing requirements depending on tonnage per annum (TPA) marketed.

INFORMATION REQUIREMENTS AT 10 TPA:

Where there are no concerns over reproduction or development, REACH calls for starting with the screening study (OECD421/422) at this tonnage.

Where there are serious concerns about the potential for adverse effects on fertility or development, either 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

REACH requires a prenatal developmental toxicity study in one species (usually rat). 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

REACH requires a prenatal developmental toxicity study in one species (usually rat). 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 called for and the need for a second species is judged on a case-by-case basis.

 

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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

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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