ItalyNOAEL-project toxicological datasheet (see an example at this link) is articulated in the following sections:
Substance identification
INCI name: the INCI name of the substance employed in toxicological studies that were used to identify the NOAEL reported
CAS number: all the CAS number for all the substance to which the chosen NOAEL can be extended
Substances with same NOAEL: the corresponding list of INCI name for the CAS numbers reported previously
Missing tests: list of missing endpoints required by SCCS to achieve a complete toxicological profile
Extract: indicates wheter a substance is an extract or not
Extraction source: the source from which the extract is obtained (fruit, leaves, flower...)
Extraction solvent: the solvent used to obtain the extract
Active ingredients: the list of active ingredients present in the extract with a link redirecting to their toxicological datasheet
Substance of reference for read-across: list of substances already present in the database employed to retrieve the NOAEL for the substance of interest
Substances with same NOAEL: the corresponding list of INCI name for the CAS numbers reported previously
Missing tests: list of missing endpoints required by SCCS to achieve a complete toxicological profile
Extract: indicates wheter a substance is an extract or not
Extraction source: the source from which the extract is obtained (fruit, leaves, flower...)
Extraction solvent: the solvent used to obtain the extract
Active ingredients: the list of active ingredients present in the extract with a link redirecting to their toxicological datasheet
Substance of reference for read-across: list of substances already present in the database employed to retrieve the NOAEL for the substance of interest
Optional fields
Annex number: if the substance is included in an Annex, this field show the Annex number, otherwise it shows the "Not in Annexes" label
Restrictions: if the substance is included in an Annex, this field shows the restrictions as reported by the SCCS
Chemo-physical properties section
INCI name: INCI name of the substance for which the info below refer
Log P: Partition coefficient of a substance in a mixture of 1-octanol/water
Molecular weight: Moleular weight of the substance
Dermal absorption: This value is always expressed as % and can be found in toxicological studies (specifically, in the pharmacokinetics section) or estimated following SCCS assumption that, if the molecular weight is equal or greater than 500 da and the Log P is <-1 or >4, the substance has a dermal absorption of 10%.
Dermal absorption (μg/cm2): dermal absoprtion expressed as μg/cm2, a parametere required in order to calculate the SED if dermal absorption (%) is missing
Dermal absorption (μg/cm2): dermal absoprtion expressed as μg/cm2, a parametere required in order to calculate the SED if dermal absorption (%) is missing
Toxicological profile of the substance
NOAEL: The NOAEL value expressed as mg/kg * bw/d
Test duration: Time of application of the substance expressed as days (d) or months (m)
Test type: Type of toxicological assay from which the NOAEL reported was retrieved
Animal model: the animal employed in the test from which the lowest NOAEL was chosen
Route of subministration: The route of subministration used in the toxicological assay
Quality system: This field indicates if the test employed to assess the NOAEL were conducted following OECD Principles of Good Laboratory Practice (GLP), OECD guidelines or other reliable but not GLP-compliant guidelines
Source: The source from which the reported NOAEL was retrieved, it can be an online toxicological database or a scientific journal
Notes: A field where additional toxicological endpoints such as mutgenicity and genotoxicity are described ando/or where the choise for the NOAEL reported is discussed in details.
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