Mammalian Toxicology Services

Comprehensive services for human health toxicology

We provide end-to-end toxicological expertise to help companies meet regulatory requirements and assess the safety of chemicals, petrochemicals, agrochemicals, inorganics and nanomaterials.

What We Do

Expert toxicology advice for regulatory compliance and product safety.

Our team of over 20 scientists provides in-depth expertise across human health endpoints, including acute, genotoxicity, irritation and sensitisation, repeated dose, reproductive and developmental toxicity, endocrine disruption, and carcinogenicity. We apply mechanistic toxicology to design tailored testing strategies, interpret complex data, and ensure dossiers are scientifically robust and regulatory-ready.

We also evaluate historical data for relevance in today’s regulatory and societal context, enabling strategies that balance compliance, scientific integrity, and business impact. Our approach integrates data gap analysis, targeted testing, study interpretation, and the application of 3Rs principles and New Approach Methodologies (NAMs) wherever possible.

Discover our global IUCLID & Chesar services

Core Toxicology Services

GLP Study Monitoring

Analytical validation of test material
Acute and repeat dose toxicity
Developmental and reproductive toxicity
Prenatal developmental toxicity (PNDT)
Extended one generation reproductive toxicity (EOGRTS)
Carcinogenicity
Genotoxicity
Sensitisation and irritation (in vitro and in vivo)
Environmental fate
Ready biodegradation screening and testing
Simulation testing (water soil sediment)
Short- and long-term toxicity to fish and invertebrates
Physical chemical properties

Study monitoring services

Dossier Assembly

Data gap analysis
Testing strategies
Literature search, screening, quality evaluation and summarising
Read-across strategies, weight of evidence assessments
Study summary preparation
Substance Identity Profiles
Read-across and Category Justification Documents
QSARs: ToxGps, OECD Toolbox, Catalogic, ChemTunes
IUCLID expertise and support

Study Design & Management

Mode of action and human relevance framework assessments
Bespoke mechanistic fit for purpose study design, interpretation and management to support
Endocrine mechanistic studies (confirm/rule out specific mechanism of action)
Exposure data to support exposure risk assessments
Bridging data to support read-across strategies
Metabolism and excretion (in vitro and in vivo)
Reproductive and developmental mechanism of action
Support with CLH dossier evaluation and regulatory review

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Additional Services

CRO auditing, evaluation and study monitoring
Test material, including UVCB analytical characterisation
DNEL calculations and exposure-based risk assessment
PBT and exposure assessments
Assembly of regulatory dossiers and CSRs
Manuscript preparation for peer review publication and submission
ED assessments, human health and the environment

The Challenges

Delivering compliant dossiers with limited internal toxicology resource.

Companies must submit complete, scientifically robust dossiers to regulatory authorities to maintain market access; however, reduced toxicology resources increase the risk of non-compliance and delayed submissions.

In the EU’s hazard-based regulatory framework, regulatory endpoints often require testing at very high exposure levels, which can confound study interpretation. Without sufficient data to demonstrate the relevance of these findings to realistic exposure scenarios, substances may be unjustifiably classified and potentially restricted.

The Solution

End-to-end toxicology expertise to meet regulatory requirements.

GLP Study Monitoring & Management

We design, manage, monitor and interpret GLP-compliant scientific studies across physico-chemical, environmental and toxicological endpoints to deliver robust, defensible, regulator-ready data that supports successful registration and compliance.

Dossier Assembly

We prepare and maintain fully compliant dossiers, staying ahead of regulatory changes and managing all correspondence with regulators to reduce the risk of market restrictions.

Dossier Gap Analysis

Our Data Gap Analysis systematically reviews available substance data against regulatory requirements to identify missing or weak areas and develop a strategic roadmap for compliant dossiers. Our IUCLID viewing and comparison capabilities in our Active Steward™ platform allows easier dossier review and automatic change management tracking.

Endocrine disruption assessments

We assess endocrine disruption by reviewing existing data, identifying gaps, developing testing strategies, conducting formal ED assessments, and evaluating the human relevance of observed effects.

Developing testing strategies

We design efficient, scientifically robust testing strategies that address regulatory needs while minimising costs, timelines, and animal testing.

QSARs

Our QSAR services use advanced computational models and regulatory-aligned tools to predict chemical hazards, fill data gaps, and support robust, defensible risk assessments.

Read-Across

We develop regulator-ready read-across justifications that leverage data from similar substances to fill data gaps and reduce the need for new testing.

Weight of Evidence (WoE)

Our weight of evidence assessments integrate multiple lines of data to support scientifically sound, transparent, and compliant conclusions without additional testing.

Robust Study Summaries (RSS)

We produce clear, high-quality Robust Study Summaries that present study data accurately and in full alignment with regulatory expectations.

Interpretation of Study Results

To meet the regulatory requirements, very high-test material exposure is required to conclude on classification, often resulting in classification that is secondary to nutrition effects, or general toxicity, or effects that are of no biological significance. Having the expertise to identify and address such cases, including generation of the appropriate data is critical to support registrants with robust defence of these observations.

The Result

Regulatory-ready dossiers and defensible safety data.

Clients benefit from robust, fully interpreted toxicological data that supports successful registration, regulatory confidence, and faster market access.

Why Choose Us?

Your trusted partner for comprehensive toxicology solutions.

We provide end-to-end support for all your toxicological needs, combining deep scientific knowledge with regulatory expertise. Our services include:

Broad Scientific & Regulatory Expertise

Extensive experience across human and environmental toxicology, combining deep scientific knowledge with a strong understanding of regulatory requirements.

End-to-End Toxicology Support

Comprehensive guidance across the full lifecycle of a substance, from study design and data generation through to regulatory assessment and dossier submission.

Efficient, Compliant Delivery

Streamlined, scientifically defensible approaches that ensure regulatory compliance while reducing internal workload and supporting confident decision-making.

Our Toxicology Experts

Expert toxicology & human safety solutions.

Penman’s human health, environmental and exposure teams, together with our regulatory expertise provide a unique opportunity to support your toxicological needs with a customer focused approach combining decades of experience across industry, testing laboratories and academia to deliver the scientific and regulatory expertise needed to address complex regulatory challenges.

Toxicologist

Ready To Strengthen Your Dossier?

Get the right data, the right strategy, and a compliant dossier.

Talk to our team today