Tabulated brief toxicological overviews of chemicals potentially present in cleaning agents

Tabulated brief toxicological overviews of chemicals potentially present in cleaning agents

Background A multi-national food manufacturing company required tabulation of key toxicological information on chemicals that may possibly be present in cleaning agents, including the most pertinent data on toxicity, health criteria values and data on exposure through food. Client A global food manufacturer. Project goals…

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Literature monitoring for (eco)toxicity data on plant protection products

Literature monitoring for (eco)toxicity data on plant protection products

Background Toxicity and ecotoxicity information is continually being published and current awareness is important to responsible companies. Bibra toxicologists have many years of experience and expertise in searching the toxicological literature Client A global company in the market of active ingredients for crop protection products….

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Strategic advice regarding the health risk assessment/risk management of elemental impurities in two injectable drug products

Strategic advice regarding the health risk assessment/risk management of elemental impurities in two injectable drug products

Background A pharmaceutical company requested an assessment of elemental impurities in each of two injectable drug formulations, in line with the ICH Q3 Guideline on Elemental Impurities (EMA, 2016; ICH, 2014). Client A pharmaceutical company. Project goals Bibra was asked to evaluate, if possible, the…

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Health risk assessment of elemental impurities in an oral drug product

Health risk assessment of elemental impurities in an oral drug product

Background A contract manufacturer of pharmaceuticals required an assessment of elemental impurities in a multi-component oral drug product, in line with the ICH Q3 Guideline on Elemental Impurities (EMA, 2016; ICH, 2014). Client A pharmaceutical contract manufacturer. Project goals Bibra was asked to evaluate the…

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Toxicological overview for a medicinal nicotine replacement device (MHRA submission)

Toxicological overview for a medicinal nicotine replacement device (MHRA submission)

Background An e-cigarette manufacturer intends to market a novel electronic nicotine delivery system (ENDS) device as a therapeutic nicotine replacement therapy in the UK. As such, the MHRA must approve the use of this device as a medicinal product. With the support of a regulatory…

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Hazard assessments on naturally-occurring compounds associated with food contamination or spoilage

Hazard assessments on naturally-occurring compounds associated with food contamination or spoilage

Background A multi-national company required concise summaries on mycotoxins (compounds arising from the presence of moulds in foodstuffs) and biogenic amines (nitrogenous compounds arising from food fermentation processes and/or food spoilage). These were to provide the most pertinent data on toxicology, health criteria values, levels…

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Targeted assessment of a cosmetic ingredient

Targeted assessment of a cosmetic ingredient

Background Bibra was asked to establish a tolerable systemic exposure for a key ingredient in an oral cosmetic product. In the theoretical case that use of the cosmetic would provide the key ingredient at a dose matching the tolerable exposure, bibra was also asked to…

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Assessment of a chemical compound for possible future SVHC investigation

Assessment of a chemical compound for possible future SVHC investigation

Background Bibra was asked to assess the likelihood that a chemical used by the client in some of its syntheses might at some point in the future be identified as a Substance of Very High Concern (SVHC) in the context of the REACH regulations. Additionally,…

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Oral toxicity and skin sensitisation assessment of scar gels

Oral toxicity and skin sensitisation assessment of scar gels

Project goals Bibra was asked to evaluate the available data on the constituents of the two products with specific focus on their potential for skin sensitisation and subchronic oral toxicity. The aim was to determine whether testing of the products in laboratory animals for these…

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A review of the effects of ultrasound on food integrity and food safety

A review of the effects of ultrasound on food integrity and food safety

Background The client wished bibra to conduct a literature search and to briefly summarise any papers relating to the effects of ultrasound treatment on food safety and food integrity. Client A large international food company. Project goals To identify the most relevant studies regarding the…

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