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.
Our team and experience
At Vivotecnia we are skilled and experienced in assessing all necessary endpoints:
- Uterine examinations
Post-mortem fetal evaluations in multiple species and strains
- External morphology
- Motor activity
- Acoustic startle response
Developmental and Reproductive Toxicity Testing Chemical Products
- Prenatal developmental toxicity study, OECD 414 and Prenatal developmental toxicity study, EPA OPPTS 870.3700
- One-generation reproduction toxicity study (rat or mouse), OECD 415; no EPA guideline
- Two-generation reproduction toxicity study (rat), OECD 416 and Reproduction and fertility effects, EPA OPPTS 870.3800
- Reproduction/developmental toxicity screening test, OECD 421 and Reproduction/developmental toxicity screening test, EPA OPPTS 870.3550
- Combined repeated-dose toxicity study with the reproduction/developmental toxicity screening test, OECD 422, and Combined repeated-dose toxicity with the reproduction/developmental toxicity test, EPA OPPTS 870.3650
- Extended, one-generation reproductive toxicity study, OECD 443; no EPA Guideline
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