Hazard assessment of three candidate compounds for use in formulation ingredients

Hazard assessment of three candidate compounds for use in formulation ingredients

Client A chemical manufacturer. Background The client had identified 3 potential compounds to be used in its materials. The company’s background afforded them access to standard engineering controls or the ability to procure any additionally required protective measures. Project goals Bibra was asked to perform…

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Derivation of PDEs for metallic and non-metallic elemental impurities in pharmaceutical products

Derivation of PDEs for metallic and non-metallic elemental impurities in pharmaceutical products

Client An analytical lab working on the behalf of a drug manufacturer. Background Metallic and non-metallic elements may be unintentionally present in pharmaceutical products as a result of their leaching from processing equipment, pharmaceutical packaging or drug delivery systems, or from their presence as impurities…

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Risk assessment of a low-level cannabinoid contaminant in food products

Risk assessment of a low-level cannabinoid contaminant in food products

Client A food production company. Background The client identified a potential contamination risk in certain of their food products. Low levels of (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis – were analytically determined. Project goals Bibra toxicologists were asked to provide an opinion…

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Toxicity reviews for a range of cannabinoids for use in inhalable consumer products

Toxicity reviews for a range of cannabinoids for use in inhalable consumer products

Client A multinational manufacturer of consumer products. Background The client requested a series of urgent toxicity reviews for more than a dozen different cannabinoids, during the development of new inhalable consumer products. These cannabinoids included (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis –…

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Benchmark dose for a veterinary product

Benchmark dose for a veterinary product

Client An animal-health product-development consultancy. Background The client was interested in mitigating the problem of a genotoxic metabolite identified in a farm animal following the topical application of a new drug. Project goals To calculate a benchmark dose (BMD) for the metabolite, for use by…

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Evaluation of the endocrine-disrupting potential of a biocidal product

Evaluation of the endocrine-disrupting potential of a biocidal product

Client A regulatory consultancy. Background An evaluation of the endocrine-disrupting (ED) properties of biocidal products is a requirement under the biocidal products regulation, as amended by Regulation (EU) 2017/2100. Project goals To provide an evaluation of the ED properties of a biocidal product for submission…

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An evaluation of the genotoxicity of fibre components and processing aids used in its manufacture

An evaluation of the genotoxicity of fibre components and processing aids used in its manufacture

Client A company that produces fibre-based dressings for advanced wound care. Background The client asked bibra to advise whether any of the compounds it used in the production of a particular type of fibre was genotoxic. Project goals Bibra was asked to identify and review…

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Cosmetic ingredients – a review of their skin irritation and skin sensitisation potential

Cosmetic ingredients – a review of their skin irritation and skin sensitisation potential

Client A global consumer products organisation. Background The client asked bibra to identify and review any published data relating to the local toxicity and sensitisation potential of some ingredients present in its cosmetic products. Project goals On a limited budget, bibra conducted literature searches on…

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A discussion of silver’s cytotoxicity with respect to the biological evaluation of a wound dressing

A discussion of silver’s cytotoxicity with respect to the biological evaluation of a wound dressing

Client An international manufacturer of wound care products. Background According to the results of an in vitro cytotoxicity assay, conducted in accordance with ISO 10993-5 guidelines, an extract of the client’s silver-containing wound dressing product demonstrated evidence of toxicity to mouse fibroblast cells. Project goals…

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Biological risk assessment of a new size of medical device

Biological risk assessment of a new size of medical device

Client An international manufacturer of wound care products. Background The client, who markets a wound dressing with existing EU and US FDA approval for long-term (>30 days), has since manufactured a larger-sized, but otherwise identical, variant of this product. Project goals According to ISO 10993-1…

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