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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A consumer health risk assessment of e-liquid containers

A consumer health risk assessment of e-liquid containers

Client A US manufacturer and supplier of container closure systems designed for e-liquids. Background In order to inform e-liquid manufacturers of any hazardous chemicals that may potentially leach from the containers into their e-liquid formulations for Premarket Tobacco Product Application (PMTA) submissions to the US…

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Evaluation of the endocrine-disrupting potential of two plant protection products

Evaluation of the endocrine-disrupting potential of two plant protection products

Client A regulatory and toxicology consultancy. Background Under the recent amendment to the plant protection products regulation (Regulation (EU) 2018/605), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two plant…

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Evaluation of the endocrine-disrupting potential of two biocidal products

Evaluation of the endocrine-disrupting potential of two biocidal products

Client A regulatory consultancy, specialising in biocidal products. Background Under the recent amendment to the biocidal products regulation (Regulation (EU) 2017/2100), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two…

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Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Client A pharmaceutical company. Background The client is interested in using CBD (cannabidiol), the major non-psychoactive component of cannabis, in a breath-operated medical inhaler device. CBD has been associated with a range of therapeutic benefits, but the current knowledge about its toxicity is something that…

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Toxicity review of CBD for use as a novel ingredient in e-liquids

Toxicity review of CBD for use as a novel ingredient in e-liquids

Client A manufacturer of e-cigarettes. Background The client is interested in introducing CBD (cannabidiol), the major non-psychoactive component of cannabis, as an ingredient to its e-liquids. The e-liquids are intended to be used in vaping products, which could potentially expose the lungs of consumers to…

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ISO 10993 risk assessment of ester extractables from a medical device

ISO 10993 risk assessment of ester extractables from a medical device

Client An analytical lab working on the behalf of a medical devices manufacturer. Background Extraction studies on a device used to transfer injectable medium identified several esters that could, as a worst case, leach over time into the contained fluid, and subsequently be injected into…

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