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.
Toxicology and Regulatory News
TRACE
Membership
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.
Pod-based ENDS device PMTA assessments
Hazard characterisation of several e-liquid ingredients
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.
Case studies
Blog
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.
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 (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.
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
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.
In silico toxicology protocols
Genetic toxicology in silico protocol
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.
Literature review and in silico prediction of metabolites
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.
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
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.
(Quantitative) Structure-Activity Relationships
Read-Across
Literature Searching & Monitoring Services
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.
ED Assessment under BPR and PPPR
ED Assessment under EU CLP and REACH
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.
We offer expert Biocidal Product Regulation consulting to help manufacturers and importers navigate the regulatory requirements for biocides.
Regulation (EU) No 528/2012
Our toxicologists are expert in assessing consumer product safety, including evaluation of cosmetics and household cleaning products.
Regulation (EC) No 1223/2009 on cosmetic products
The General Product Safety Regulations 2005
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.
Revised Tobacco Products Directive (TPD2)
Premarket Tobacco Product Application
Health risk assessments relating to the excipient components of the Voke® formulation
Cannabinoids – preparation of several inhalation focused toxicity profiles
We have been providing food toxicology services since 1961, including safety evaluations of flavourings, additives, and food packaging and other food-contact materials.
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
We are experts in medical device toxicology and provide assessments to evaluate products against ISO 10993 and other regulatory guidance.
Biocompatibility review under ISO 18562 guidelines
Toxicological risk assessment of leachables from a combination product
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.
In silico assessment of impurities in a pharmaceutical
Derivation of a dermal HBEL for a hormone ester
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.
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
We are leading suppliers of REACH compliance services, helping clients prepare, submit and revise registration dossiers and respond to evaluation decisions.
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
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.
Derivation of an intravenous PDE for a common leachable
We provide expert support to the growing cannabinoid sector, including toxicological advice and human health risk assessments of CBD and other cannabinoids.
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.
We are comprised of highly skilled toxicologists and administrative wizards, working together under one roof – we look forward to introducing you to our team.
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.
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.
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.
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
About bibra
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.
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.
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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