Testing for Chemicals Products
Our testing solutions ensure the practical implementation of REACH requirements on developmental and reproductive toxicity testing requirements according tonnage marketed per year.
- INFORMATION REQUIREMENTS AT 10 TPA:
Where there are no concerns over reproduction or development REACH calls to start 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 pre-natal developmental toxicity study or a two- or extended one generation reproductive toxicity study may be proposed instead of the screening study.
- INFORMATION REQUIREMENTS AT 100 TPA
REACH requires a pre-natal developmental toxicity study in one species (usually rat) If the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues conduct a two-generation or extended one-generation reproductive toxicity study in one species.
- INFORMATION REQUIREMENTS AT 1000 TPA
REACH requires a pre-natal developmental toxicity study in one species (usually rat). Need for a second species judged on a case-by-case basis Two-generation or extended one-generation reproductive toxicity study in one species. Need for a second species judged on a case-by-case basis.
Our team and Experience
Vivotecnia offers the high level of scientific expertise needed to address special DART regulatory studies requirements, including fertility, developmental toxicity (teratology), juvenile studies and multigenerational reproductive studies. Tests can be performed by using a variety of administration routes ranging from dermal to intravenous infusion. These designs are customized to individual Sponsor needs aligned with regulatory guidance, including FDA, EMEA, and OECD standards.
At Vivotecnia we are experienced and skilled in assessing all necessary endpoints:
- Uterine examinations
Post-Life 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 in Rat/Rabbit. OECD 414; OPPTS 870.3700
- One Generation Reproduction Toxicity Study in Rat. OECD 415 (No EPA Guideline)
- Two-Generation Reproduction Toxicity Study in Rat. OECD 416; OPPTS 870.3800
- Reproduction/Developmental Toxicity Screening Test. OECD 421; OPPTS 870.3550
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. OECD 422; OPPTS 870.3650
- Extended One-Generation Reproductive Toxicity. OECD 443 (No EPA Guideline)
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