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Reproductive Toxicity Testing

Reproductive Toxicity Testing

Reproductive toxicity testing is a critical component in drug development, providing essential insight into how new pharmaceutical candidates may affect fertility, embryonic development, and offspring health. Early identification of reproductive risks enables optimized compound selection, reduces late-stage attrition, and informs safe dosing strategies. BOC Sciences offers a comprehensive suite of reproductive toxicity services tailored to pharmaceutical pipelines, including fertility function, embryo-fetal development, peri- and postnatal assessments, extended one-generation, and multi-generation studies, as well as rapid in vitro screening. Leveraging advanced analytical platforms, customizable study designs, and a multidisciplinary team of toxicologists and pharmacologists, BOC Sciences delivers precise, actionable reproductive toxicity data to support informed drug development decisions globally.

BOC Sciences Reproductive Toxicity Testing Portfolio

Fertility Function Testing

Covers comprehensive evaluation of male and female reproductive capacity, including gametogenesis, mating success, conception rate, and gamete quality analysis, such as sperm motility and oocyte maturation. At BOC Sciences, we design exposure schedules aligned with reproductive cycles to deliver precise and reproducible fertility data supporting compound screening and mechanism studies.

Embryo-Fetal Development Testing

Focuses on assessing the effects of test substances during the critical embryonic period, examining fetal morphology, organ development, body weight, and malformation incidence. BOC Sciences provides integrated studies in rodents and rabbits, ensuring reliable characterization of developmental outcomes and early identification of potential teratogenic risks.

Peri- and Postnatal Development Testing

Evaluates maternal performance, delivery outcomes, lactation behavior, and postnatal growth of offspring through weaning and adolescence. At BOC Sciences, our studies incorporate behavioral, neurological, and immunological endpoints to offer a complete understanding of developmental and functional consequences following perinatal exposure.

Extended One-Generation Reproductive Testing

Extends assessment beyond parental generation to F1 offspring, enabling a more holistic evaluation of reproductive and developmental endpoints. BOC Sciences applies modular study designs that capture critical life-stage data efficiently, supporting data-driven decision-making for long-term safety and risk assessment.

Multi-Generation Reproductive Testing

Monitors reproductive performance and developmental parameters across two or more generations (F0–F1–F2). Our BOC Sciences team provides high-integrity multi-generation models for compounds requiring detailed intergenerational profiling, ensuring comprehensive insight into chronic and hereditary reproductive outcomes.

Reproductive Toxicity Screening

Offers rapid, cost-effective in vitro and in vivo screening methods including sperm viability, endocrine receptor activity, and early embryotoxicity assays. At BOC Sciences, we employ high-throughput platforms for preliminary hazard identification, enabling efficient compound prioritization prior to full-scale reproductive toxicity studies.

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Our team offers tailored study design and rapid results to accelerate your development process.

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Range of Samples for Reproductive Toxicity Testing

Our reproductive toxicity testing services accommodate a wide range of sample types to evaluate potential effects on fertility, development, and reproductive health.

MTT Assay

Small Molecule Compounds

  • Pharmaceutical candidates
  • Synthetic chemical intermediates
  • Industrial chemicals
CCK-8 Assay

Biological Products

  • Recombinant proteins
  • Monoclonal antibodies
  • Enzymes and peptides
Caspase-3 Activity Assay

Vaccines

  • Viral vectors
  • Adjuvants
  • Nucleic acid vaccines
LDH Assay

Pesticides

  • Herbicides, insecticides, and fungicides
  • Agrochemical formulations
  • Biopesticides
Western Blotting

Personal Care / Cosmetics

  • Skincare formulations
  • Haircare and body care products
  • Fragrances and essential oils
ELISA

Food Contact Materials

  • Packaging polymers and coatings
  • Additives and stabilizers
  • Flexible and rigid plastics

Reproductive Toxicity Testing – Inquiry Form

Share your compound or product details, and our experts will provide tailored guidance and testing strategies.

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In Vitro and Alternative Evaluation Platforms

We provide a series of in vitro and alternative methods as part of our reproductive toxicity testing services. These approaches are designed for early-stage screening and mechanistic evaluation, offering high throughput, reduced animal usage, and improved predictive reliability.

Testing MethodPrinciple / FeaturesKey Evaluation Endpoints
Embryonic Stem Cell Test (EST) Detects whether a compound inhibits the differentiation of mouse embryonic stem cells into cardiomyocytes.Differentiation rate, cytotoxicity threshold.
Frog Embryo Teratogenesis Assay (FETAX) Uses Xenopus laevis embryos to evaluate developmental toxicity under controlled exposure conditions.Embryo survival rate, malformation rate, developmental delay.
In Vitro Gamete and Fertilization Tests Includes Sperm Penetration Assay (SPA), in vitro fertilization (IVF), and embryo culture observation.Gamete quality, fertilization rate, embryonic growth assessment.
Endocrine Disruption Screening Cell- and molecular-level assays such as Estrogen/Androgen Receptor Binding (ER/AR) and Transactivation Assays (YES/YAS, E-Screen).Hormone receptor binding activity, pathway response changes.
Computational Modeling Employs graph convolutional networks (GCN) and other machine learning algorithms to predict potential reproductive and developmental toxicity of organic and inorganic compounds.Predicted toxicity endpoints, probability scores, mechanistic correlation.

BOC Sciences Reproductive Toxicity Testing Workflow

Requirement Understanding

1Initial Consultation and Requirement Assessment

Clients provide sample details and testing objectives. Our scientific consultants evaluate requirements and design a tailored reproductive toxicity strategy.

Experimental Design

2Study Design and Experimental Planning

The team develops study protocols including selection of test models, dose groups, administration routes, and key reproductive endpoints.

Model System Construction

3Experimental Execution and Data Acquisition

Procedures include animal handling, dosing preparation, tissue sampling, and reproductive organ histopathology, with real-time monitoring of experimental parameters and endpoints.

Pharmacological Testing Execution

4Data Analysis and Report Delivery

Statistical analysis and evaluation of reproductive toxicity endpoints are performed, results visualized in tables/graphs, and a professional report with scientific interpretation is delivered.

Reproductive Toxicity Solutions for Diverse Needs

01

Solution for Biotech Innovators

We provide tailored reproductive toxicity testing for innovative biologics and small molecules, including multi-generation in vivo studies and mechanistic in vitro assays. Our solutions help biotech developers evaluate reproductive safety efficiently, supporting informed decisions throughout early R&D stages.

02

Solution for Pharmaceutical Leaders

BOC Sciences offers comprehensive reproductive toxicity testing for drug candidates, covering embryo-fetal development, fertility, and pre- and post-natal assessments. Our customized strategies enable pharmaceutical companies to optimize study design and generate reliable safety data rapidly.

03

Solution for Academic Researchers

We support academic and translational research with flexible reproductive toxicity testing solutions, including mechanistic studies and exploratory in vitro/in vivo assays. Our services help researchers investigate reproductive effects, facilitating deeper understanding of compound safety profiles.

04

Solution for Contract Research Partners

BOC Sciences delivers adaptable reproductive toxicity testing solutions for CROs and research partners, providing study design, protocol optimization, and data analysis. Our services enhance partner efficiency and accuracy, enabling robust reproductive safety evaluations for diverse compound pipelines.

Kickstart Your Reproductive Toxicology Program Now!

Contact BOC Sciences to access our expert reproductive toxicity services. We provide thorough assessments across multiple endpoints, ensuring high-quality, actionable data to streamline your R&D pipeline and facilitate faster, evidence-based project progression.

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Key Advantages in Reproductive Toxicology Assessment

Comprehensive Reproductive Toxicity Testing

We provide integrated reproductive toxicity testing services covering multi-generational studies to ensure broad-spectrum chemical safety evaluation.

Advanced Analytical Platforms

Our laboratories employ cutting-edge analytical technologies, enabling detection of subtle toxicological effects across diverse biological matrices.

Expert Multidisciplinary Team

Our team combines toxicologists, pharmacologists, and data scientists to deliver reliable interpretation and actionable insights from complex datasets.

Customized Study Designs

We provide flexible testing strategies with tailored protocols, enabling efficient evaluation across diverse compound classes and endpoints.

Applications Enabled by Our Reproductive Toxicity Testing

Compound Discovery & Screening

  • Early Toxicity Profiling
  • Embryo Viability Evaluation
  • Gamete Interaction Analysis
  • Developmental Risk Assessment

Target Analysis

  • Cellular Pathway Analysis
  • Gene Expression Monitoring
  • Hormonal Response Evaluation
  • Epigenetic Impact Assessment

Lead Compound Optimization

  • Dose-Response Characterization
  • Metabolic Interaction Testing
  • Off-Target Effect Screening
  • Structure-Activity Assessment

Reproductive Toxicity Testing Case Studies and Success Stories

Client Needs: A biotech company developing a small-molecule oncology candidate required an assessment of potential reproductive toxicity to inform preclinical lead selection and minimize downstream attrition.

Challenges: The client needed reliable detection of subtle gonadal changes amid species-specific fertility differences and to achieve reproducible reproductive endpoints across cohorts.

Solution: BOC Sciences designed an integrated reproductive toxicity testing plan, combining multi-generational rodent studies with hormonal profiling, sperm/oocyte quality assessment, and detailed histopathology. Advanced imaging and stereological quantification provided sensitive detection of subtle gonadal changes, while optimized dosing schedules minimized inter-animal variability.

Outcome: Delivered comprehensive reproductive toxicity data with high sensitivity, enabling precise risk evaluation, informed structural optimization, and confident progression of the oncology candidate into subsequent preclinical stages.

Client Needs: A pharmaceutical company focusing on CNS therapies needed reproductive toxicity evaluation to support compound prioritization among several neuroactive candidates.

Challenges: The client faced variability in BBB penetration and endocrine effects, making standard reproductive endpoints unreliable for candidate comparison.

Solution: BOC Sciences implemented a customized reproductive toxicity testing protocol, integrating hormone assays, mating trials, and reproductive organ histopathology. Cross-species comparison and repeated-measures analysis enhanced detection of subtle endocrine disruptions. Automated data capture and high-resolution imaging improved reproducibility and statistical confidence.

Outcome: Produced actionable reproductive toxicity profiles, revealing candidate-specific fertility risks and dose-response relationships, supporting informed lead selection and structural refinement to mitigate reproductive liabilities.

Client Needs: A biopharmaceutical company developing an oral anti-diabetic agent sought to assess long-term reproductive effects across generations to optimize early-stage candidate selection.

Challenges: The client struggled to monitor multi-generational developmental and reproductive endpoints and detect subtle skeletal or organ maturation changes.

Solution: BOC Sciences conducted a structured multi-generational reproductive toxicity study, combining developmental landmark assessment, gametogenesis evaluation, and organ histomorphometry. Continuous biomarker monitoring and automated data integration enabled sensitive detection of intergenerational reproductive effects and minimized variability.

Outcome: Delivered high-resolution reproductive toxicity profiles across two generations, identifying potential developmental susceptibilities and providing guidance for chemical optimization, dose selection, and strategic candidate prioritization.

Frequently Asked Questions

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Client Reviews: Reproductive Toxicity Testing

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