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Toxicological Risk Assessment

Literature Monitoring & Searching

Read-Across Services

(Q)SAR Services

TK & ADME Assessments

Safety Benchmarking

Testing Strategies

Endocrine Disruption Evaluation

Services
Our expertise covers all aspects of the human health hazard characterisation and risk assessment of chemicals. We can support you with searches of the toxicological literature, development of testing strategies and employment of alternative approaches to testing.

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Toxicology and Regulatory News

TRACE

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Hazard Assessment & Characterisation
Hazard assessments and characterisation based on a comprehensive understanding of the toxicological literature define the dose-response for all biological effects and routes of administration. Our expert toxicologists are highly experienced in summarising data including carcinogenicity, genotoxicity, reproductive and developmental toxicity and endocrine disruption.

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Case studies in this area

Pod-based ENDS device PMTA assessments

Hazard characterisation of several e-liquid ingredients

Toxicological Risk Assessment
Toxicological health risk assessments relate the health hazards of a chemical to its potential exposure levels. Our experienced toxicological risk assessors identify a critical health-based guidance value and estimate possible exposures to quantify the health risk to e.g. workers, consumers or patients.

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Additional Resources

Case studies

Blog

Literature Monitoring & Searching
Robust risk assessment relies on quality data. We have years of experience in literature monitoring and searching services, selecting and using search terms to obtain the highest quality, most relevant and reliable data for use in health hazard and risk assessments. Our in-house database, TRACE, gives immediate access to critical publications often not reliably captured elsewhere.

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Related Resources

Knowledge is key. Part 1: Toxicity literature searching, a personal history

Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)

Read-Across Services
Read-across (using toxicity data on structurally- and chemically-similar compounds to evaluate a substance that has been inadequately tested) can reduce the need for new testing. Our toxicologists have extensive experience using read-across in regulatory submissions in many sectors.

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Case studies in this area

Determining a suitable read-across surrogate for a pharmaceutical impurity

Toxicological risk assessment of leachables from a syringe medical device

Evaluating the health risks posed by extractables and leachables from an ENDS device

(Q)SAR Services
Our (Q)SAR services include modelling to predict physico-chemical or (eco)toxicological properties of a compound is a useful screening tool and can help reduce the need for costly and animal-intensive laboratory tests. Our team has extensive expertise in running several well-accepted models and interpreting the results.

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Helpful links

In silico toxicology protocols

Genetic toxicology in silico protocol

TK & ADME Assessments
Understanding the toxicokinetic (absorption, distribution, metabolism and excretion) properties of a compound is key to effective hazard characterisation. Our toxicologists can interpret existing data and produce TK and ADME assessments based on structure and physico-chemical properties.

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Case study in this area

Literature review and in silico prediction of metabolites

Safety Benchmarking
Safety benchmarking is an essential part of assessing the risk chemicals pose to human health. We specialise in identifying and deriving safety benchmarks, which represent the maximum exposure that will pose no significant health risk.

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Case studies in this area

ISO 18562 evaluation of a medical device in contact with the breathing gas pathway

N-Nitrosamines risk assessment for a pharmaceutical product

PDE for a leachable in an intravenous pharmaceutical

Testing Strategies
Commissioning laboratory animal studies should always be the last resort. Our experts can suggest where alternative testing strategies such as read-across, in silico predictions or in vitro assays could be used. If testing is unavoidable, we can commission and monitor the necessary studies and incorporate the results into hazard and risk assessments.

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Related pages

(Quantitative) Structure-Activity Relationships

Read-Across

Literature Searching & Monitoring Services

Endocrine Disruption Evaluation
Endocrine-active chemicals, which can disrupt the action of hormones in the body potentially affecting normal growth and development or reproduction, are of significant toxicological and regulatory concern. Our experts are skilled in using all available data to conduct endocrine disruption evaluations.

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Key areas of endocrine disruption work

ED Assessment under BPR and PPPR

ED Assessment under EU CLP and REACH
Industries

Industries

Biocides

Consumer Products

Nicotine + Tobacco

Food + Food Contact

Medical Devices

Pharmaceuticals

Plant Protection Products

REACH Compliance

Extractables & Leachables

Cannabinoids

Industries
We have been providing chemical hazard and risk assessments for a variety of industries for over 60 years. Find out how our expert toxicologists can support you and your business.

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Other scientific support

Toxicology and Regulatory News

TRACE

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Biocides
We offer expert Biocidal Product Regulation consulting to help manufacturers and importers navigate the regulatory requirements for biocides.

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Helpful link

Regulation (EU) No 528/2012

Consumer Products
Our toxicologists are expert in assessing consumer product safety, including evaluation of cosmetics and household cleaning products.

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Helpful information

Regulation (EC) No 1223/2009 on cosmetic products

The General Product Safety Regulations 2005

Nicotine + Tobacco
We offer safety assessments and can assist in preparing regulatory data packages for a range of nicotine and tobacco products, including e-cigarettes and e-liquids.

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Helpful information

Revised Tobacco Products Directive (TPD2)

Premarket Tobacco Product Application

Pod-based ENDS device PMTA assessments

Health risk assessments relating to the excipient components of the Voke® formulation

Cannabinoids – preparation of several inhalation focused toxicity profiles

Food + Food Contact
We have been providing food toxicology services since 1961, including safety evaluations of flavourings, additives, and food packaging and other food-contact materials.

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Case studies in this area

Determining a Specific Migration Limit (SML) for a data-deficient compound identified in food labels

Δ9-THC – a low-level impurity in food

Summarising hazard data on food additives and contaminants

Medical Devices
We are experts in medical device toxicology and provide assessments to evaluate products against ISO 10993 and other regulatory guidance.

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Case studies in this area

ISO 18562 evaluation of a medical device in contact with the breathing gas pathway

Biocompatibility review under ISO 18562 guidelines

Toxicological risk assessment of leachables from a combination product

Pharmaceuticals
Our team has many years of experience preparing pharmaceutical toxicology assessments, including evaluation of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.

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Case studies in this area

In silico assessment of impurities in a pharmaceutical

Derivation of a dermal HBEL for a hormone ester

N-Nitrosamines risk assessment for a pharmaceutical product

Plant Protection Products
Our team have extensive experience identifying, interpreting and summarising toxicological data on Plant Protection Products, including the specific literature searches required for PPP renewal dossiers.

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Helpful information

Regulation (EC) 1107/2009

Evaluation of the endocrine-disrupting potential of a plant protection product

Literature Review Report in support of a plant protection product active substance regulatory submission

REACH Compliance
We are leading suppliers of REACH compliance services, helping clients prepare, submit and revise registration dossiers and respond to evaluation decisions.

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Helpful information

Regulation (EC) No 1907/2006

Regulation (EC) No 1272/2008

Updating REACH dossiers following ECHA Evaluation decisions

REACH registration of nearly 100 related metal compounds

Extractables & Leachables
Our team can provide expert toxicological risk assessments for extractables and leachables in both pharmaceuticals and medical devices to ensure all products placed on the market are safe for patients.

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Case studies in this area

ISO 18562 evaluation of a medical device in contact with the breathing gas pathway

PDE for a leachable in an intravenous pharmaceutical

Derivation of an intravenous PDE for a common leachable

Cannabinoids
We provide expert support to the growing cannabinoid sector, including toxicological advice and human health risk assessments of CBD and other cannabinoids.

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Case studies in this area

Cannabinoids – preparation of several inhalation focused toxicity profiles

Δ9-THC – a low-level impurity in food
About bibra

About bibra

Our Team

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Case Studies

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About bibra
We are a world-class team of highly skilled toxicologists – whether you are bringing a new product to market, dealing with a contamination crisis or submitting a dossier, we can assist.

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Toxicology and Regulatory News

TRACE

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Our Team
We are comprised of highly skilled toxicologists and administrative wizards, working together under one roof – we look forward to introducing you to our team.

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Toxicology and Regulatory News

TRACE

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ESG
As a scientific consultancy, the planet is very important to us. Our impact on the earth, how we treat people and our morals as a company are at the forefront of everything we do.

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Toxicology and Regulatory News

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Case Studies
Our Case Studies have been written over several years, to showcase some of the many interesting hazard and risk assessments we perform across a huge variety of industries.

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Other scientific support

Toxicology and Regulatory News

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Blog
Contributions to our Blog are written by all of the bibra toxicologists, and are filled with information on a vast array of topics, from animal testing to AI and everything in between.

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Other scientific support

Toxicology and Regulatory News

TRACE

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Scientific Support

Scientific Support

Toxicology and Regulatory News

TRACE

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Scientific Support
Whether you’re looking for our long-running publication, “Toxicology and Regulatory News” (TRN), details on our TRACE database or further information on our Membership scheme, you’re in the right place

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Toxicology and Regulatory News
TRN is our free monthly current awareness publication containing expert commentaries on key toxicological reports, and is aimed at both toxicologists and non-specialists alike.

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About bibra

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TRACE
TRACE has been built over the last 50 years, to be an unrivalled databank of more than half a million key documents on the health effects of chemicals. This databank (and its associated database) provides comprehensive coverage of chemicals and regulatory guidelines.

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About bibra

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Our Membership scheme guarantees our clients priority access to our toxicologists, and a fixed price fee structure that represents excellent value for money, whether you have long-term strategic projects or short term urgent work.

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Craig Freeman's blog articles

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