Il primo database di dati tossicologici NOAEL on demand
Il database NOAEL per le tue esigenze
NoD (NOAEL On Demand) is a database of toxicological data, the NOAEL (No Observed Adverse Effect Level), created in response to the need of regulatory managers in the cosmetics industry for pre-processed, pre-filtered and pre-selected information.
The database, thanks to the partnership with Ambrosialab, University of Ferrara includes over 800 substances and is constantly growing.
The NOAEL in the Product Information File
In order to release a cosmetic product on the market, it is necessary to fill in the PIF, which, for the calculation of the MoS (Margin of Safety), must take into account the NOAELs.
MoS is considered and calculated on the basis of the safety of a given substance used in the formulation of a cosmetic product. The MOS of a substance can be calculated by dividing its NOAEL value, chosen and motivated by the Safety Assessor, by its possible SED, as described in the "SCCP’s notes of guidance for the testing of cosmetic ingredients and their safety evaluation“.
How it works
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Once the request has been confirmed, the sheets will be supplied in a protected .pdf format.
For Dossier Manager users the tabs will be automatically attached to the chapters of the PIFs containing the substances to which they refer, and the toxicological data contained will be automatically recorded in the program for calculating the MOS.
Where no NOAEL data is available for an ingredient, a summary note shall be provided on the different aspects related to the effects of the ingredient at the dermal level published by authoritative sources, providing useful information for the safety assessor. On the basis of the available data, a summary safety assessment of the ingredient in cosmetic products shall be carried out whenever possible.
Note on the criteria for selecting and collecting information
The No Observed Adverse Effect Level (NOAEL) is defined as the highest dose or level of exposure for which no treatment-related adverse effects are observed. The NOAEL of a substance is derived from Repeated Dose Toxicity studies, which involve the daily administration of predefined doses of the substance for prolonged periods of time. NOAEL is expressed in mg/kg bw/day.
Only studies published by reliable sources (e.g. ECHA, CIR, SCCS, EFSA, toxicological databases, scientific literature) are considered for the determination of NOAEL for a substance. In the absence of such studies, the value reported by the supplier of the raw material, if available, may be taken into account.
Available repeated dose toxicity studies shall be analysed in detail to assess the type of study conducted, the mode of administration, the dosages, the toxicological effects monitored, their severity and reversibility.
As a general principle, if different NOAEL values are available for the same substance, the more conservative (lower) value is preferred. More specifically, the following selection criteria are applied:
- Studies in which several doses have been tested are preferred, including studies in which the NOAEL does not correspond to the maximum dose tested;
- studies in rodents, preferably rats, are preferred in the following order of preference: subchronic toxicity (90 days), chronic toxicity (2 years), carcinogenesis, developmental and reproductive toxicity, short-term toxicity (28 days).
The information published in accordance with these criteria has been collected and submitted in good faith; this does not relieve the Safety Assessor of his responsibilities under the Standard.