Development of a non-target strategy for evaluation of potential biological effects of inhalable aerosols generated during purposeful room conditioning using an inhalation model.

Objectives: An integrated inhalation approach was outlined to estimate potential adverse acute inhalation effects of aerosols from commercial nebulizer applications used for purposeful room conditioning such as disinfection, scenting or others. Aerosol characterization, exposure estimation and evaluation of acute biological effects by inhalation were included to generate dose-response data, allowing for determination of lowest observable adverse effect levels (LOAELs). Correlation of these to estimates of human lung deposition was included for quantitative to extrapolation approach (QIVIVE) for acute effects during human exposure.

Contact allergy to hair-colouring products: a cosmetovigilance follow-up study by four companies in Europe from 2014 to 2017.

Background: A previous analysis of undesirable events (UEvs), reported to four major companies following the use of hair-colouring products in Europe, showed that the reporting rates were stable for both oxidative and direct hair-colouring products over the period 2003-2006.

Objectives: In order to verify the impact of risk management measures implemented since 2006, as well as the impact of a new Commission Regulation (No 1223/2009), the same four companies analysed cosmetovigilance data collected over an additional four-year period (2014-2017). The objective was to determine whether there was any time effect, country effect, or product type effect, as well as identify risk factors.

Threshold of Toxicological Concern (TTC) for Botanical Extracts (Botanical-TTC) derived from a meta-analysis of repeated-dose toxicity studies.

Threshold of Toxicological Concern (TTC) is a promising approach for evaluating the human health risk for systemic toxicity when there is a lack of toxicological information. The threshold for systemic toxicity is reportedly 1800, 540, and 90 μg/day for Cramer I-III chemical structures, according to Munro's structural decision tree, and 0.15 μg/day for genotoxic compounds.

A critical appraisal of the sensitivity of in vivo genotoxicity assays in detecting human carcinogens.

Genotoxicity testing is an important part of standard safety testing strategies. Animal studies have always been a key component, either as a mandatory part of the regulatory test battery, or to follow-up questionable in vitro findings. The strengths and weaknesses of in vivo assays is a continuous matter of debate, including their capacity to predict (human) carcinogenicity.