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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Acceptable intake for an impurity in a new anticancer drug

Acceptable intake for an impurity in a new anticancer drug

Client A pharmaceutical company. Background A possible impurity was identified in the development of a new anticancer drug. Project goals Bibra was asked to conduct Leadscope analyses on this impurity to assess its genotoxic/mutagenic potential and to subsequently classify it in line with ICH guideline…

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Health risk assessment of a nicotine salt

Health risk assessment of a nicotine salt

Background Nicotine can be added to e-liquids either in its basic form or as a nicotine salt. Bibra was approached by a client interested in assessing the use of a particular salt as a source of nicotine in one of its e-liquid products. Client A…

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Health risk assessment of impurities in a nasal spray device

Health risk assessment of impurities in a nasal spray device

Client A pharmaceuticals manufacturer. Background A partially characterised impurity (refined to one of two isomers) was identified in a nasal drug product after storage under exaggerated conditions. Project goals Bibra was asked to evaluate the toxicological risks posed to patients by one or other (or…

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Human health risk assessment of skin patch leachables in artificial sweat

Human health risk assessment of skin patch leachables in artificial sweat

Client An analytical laboratory working on behalf of a pharmaceuticals manufacturer. Background A number of organic chemicals were detected in artificial sweat tests on a skin patch designed to supply an anaesthetic to patients. Some of these were found at levels above the relevant analytical…

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Consideration of HCV data on two substances present in food

Consideration of HCV data on two substances present in food

Background The client was interested in decisions made by the Scientific Committee for Food (SCF) on two food constituents (one a single chemical, the other a group) in the 1990s, which have not since been updated. For the single chemical, no acceptable daily intake (ADI)…

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