Client
Product label and packaging manufacturer.
Background
The client was informed by a supplier that a chemical compound with a worrying structure was present within a food label ink. As a Food-Contact Material (FCM), the client wanted the health risks posed by this compound to be evaluated.
Project goals
Bibra was asked to review the toxicological literature available for this compound and, in the absence of any suitable toxicity data, identify relevant read-across analogues that could be evaluated to ultimately derive a Tolerable Daily Intake (TDI) and Specific Migration Limit (SML). [The SML is defined as the maximum permitted amount of a given substance released from a material or article into food or food simulants.]
Approach and outcome
Comprehensive literature searches identified only limited substance-specific toxicity data, so bibra considered the chemical structure of the compound and identified a range of structurally related analogues with more robust toxicological datasets. Quantitative Structure-Activity-Relationship (QSAR) analysis was also conducted to determine mutagenic potential, as well as to support the read-across.
From the dataset, a variety of potentially critical adverse effects were identified. These included carcinogenicity, reproductive toxicity, neurotoxicity and effects on the liver and kidneys.
For each of these endpoints, critical Points of Departure (PoDs) were established from the key laboratory animal studies. Suitable Uncertainty factors were then applied to the PoDs to account for interspecies and interhuman variation, the duration of the key study, extrapolation from a Lowest-Observed-Adverse-Effect Level (LOAEL) to a No-Observed-Adverse-Effect Level (NOAEL), any study limitations, and/or the use of read-across, as necessary, to generate TDI values.
The lowest and therefore most conservative TDI could then be converted to a SML (mg/kg food) by multiplying by the standard adult body weight of 60 kg and dividing by the default amount of food consumed daily, which is typically assumed to be 1 kg in the EU and UK.
The resulting SML could then be used by the client in determining whether any migration of this compound from the label to food products presents a potential health risk to consumers.
