Customized Assessment
With our expertise in toxicology and industrial hygiene, we can ensure compliance with regulatory, occupational, and environmental standards while reducing your risk.
Toxicology and Risk Assessment Support
Confidently Manage Regulatory Obligations with Our Tailored Toxicology and Risk Assessment Services
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Regulatory
ExpertiseWe provide expertise in the area of risk assessment, covering hazard identification, dose-response, exposure assessment, and risk characterization to identify health and environmental risks.
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Tailored
SolutionsOur team can support you in handling occupational exposure concerns, including assigning exposure bands and providing industrial hygiene services.
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Comprehensive
SupportWe offer customized solutions designed to meet your specific needs, ensuring thorough risk management from start to finish.
Expert Toxicology &
Risk Assessment Strategies
Mitigating Risks, Ensuring Safety: Your Trusted Partner in Toxicology and Risk Assessment
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Risk Assessment Framework
- Hazard identification is the process of recognizing and describing potential hazards that could cause harm to human health, the environment, or property. This step involves identifying substances, activities, or conditions that could pose risks, such as chemical exposure, physical dangers, or biological agents, and evaluating their potential to cause adverse effects.
- Dose-response is the process of determining the relationship between the amount of exposure to a substance (dose) and the severity of its effects (response). It helps to quantify how different levels of exposure may lead to varying degrees of harm, guiding the establishment of safe exposure limits and understanding potential health risks.
- Exposure assessment is the process of evaluating how, when, and to what extent individuals or populations come into contact with a potentially harmful substance. It involves estimating the frequency, duration, and intensity of exposure, helping to determine the level of risk associated with that exposure.
- Risk characterization is the process of combining information from hazard identification, dose-response, and exposure assessment to estimate the overall risk posed by a substance. It provides a clear understanding of the likelihood and severity of potential adverse effects, helping to inform decision-making and risk management strategies.
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Toxicology Requirements
- Toxicology is crucial to chemical risk assessment as it provides the scientific foundation for understanding the potential harmful effects of chemicals on human health and the environment. Through toxicological studies, the nature, severity, and mechanisms of toxicity are identified, helping assess the risks associated with exposure. This data informs decisions on safe exposure limits, regulatory compliance, and protective measures, ultimately ensuring the safe use and management of chemicals.
- Toxicological data are generated through experimental (in vitro, ex vivo, in vivo) and non-experimental (in silico) methods, with data requirements under REACH varying by substance tonnage, where Annex VII requires minimal data mainly from in vitro/in silico routes, while Annex VIII mandates in vivo data and exposure risk assessments for chemical evaluation.
Our Tailored Toxicology & Risk Assessment Solutions
Personalized Guidance
Our services include GHS classification, hazard communication, cosmetic safety assessments, toxicology risk assessments, consultation for testing requirements, conformance assessments for labeling regulations and occupational exposure banding.
Continual Support
We offer ongoing support with evaluating your product portfolio and monitoring the frequently updated regulations to ensure that you stay in compliance.
Meet Our Toxicology and Risk Assessment Expert
Dedicated professionals guiding your compliance journey.
Miriam McAuliffe |MSc|
Service Manager
Dublin, Ireland
Concy Aciro |UKRT, ERT, DABT|
Senior Consultant: Toxicology
Kent, England
Frequently Asked Questions
Toxicological data are generated via experimental (in vitro, ex vivo and in vivo) and non-experimental (in silico) routes.
Under REACH, toxicological data generation is determined by the tonnage of the substance i.e., the Annex which they fall under. For example, Annex VII, only minimal toxicological data is generated and mainly from in vitro/in silico routes with exception of an acute in vivo data. At this Annex no exposure risk assessment is required, however, this is a requirement for Annex VIII where in vivo data are generated. At Annex VIII data from repeated dose exposure is generated and are used to derived point of departures (PODs) which are used in exposure and risk assessment for the chemical.
-POD is the point on a toxicological dose-response curve established from experimental data or observational data generally corresponding to an estimated low effect level or no effect level.
– the most common POD used in toxicological risk assessment are no-observed-adverse-effect level (NOAEL), lowest-observed-adverse-effect level (LOAEL) and benchmark dose (BMD). Below are examples of how POD is applied to risk assessments of chemicals and cosmetics.
– For REACH chemical safety assessment, NOAEL or LOAEL are used to derive the derived no effect level (DNEL) for human health. The POD is divided by assessment factors which consider, inter/intraspecies difference, duration of exposure and route of exposure as well as data quality. The risk of a chemical substance to humans can be considered to be controlled/acceptable if the exposure levels estimated do not exceed the appropriate DNEL (i.e., exposure estimate/DNEL<1).
– For cosmetic, the POD is used to derived margin of safety (MOS) i.e., the ratio of no-observed-adverse-effect level (NOAEL) to estimated exposure dose where the safety of a cosmetic ingredient is considered acceptable if the MOS ≥ 100.
These are examples where the POD based on human data or where human exposure is evaluated based on biological monitoring data. But this is very rare and most data available for risk assessment are based on experimental animals and therefore POD will need to be modified.
Modification is necessary due to the differences between exposure routes and experimental animals and humans. Therefore, the modification will need to account for the following.
1. Route-to-route extrapolation i.e., converting an oral POD to an inhalatory POD
2. Accounting for duration of exposure of experimental animals and human exposure duration for example, 6 hours per day for experimental rat and 8 hours per day for workers.
3. The difference in bioavailability exposure routes and experimental animals and humans.