Sodium anisate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No 1907/2006, Annex VIII, section 8.5, column 2, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route in addition to the oral route (8.5.1) for substances other than gases. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.
In consideration of the same section (Column 2 of Annex VIII, Section 8.5.3), testing by the dermal route does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route, and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).
Based on the RA-A the the LD50 of sodium aniste is expected to be > 5000 mg/kg bw and accordingly, the substance is therefore not classified as STOT SE by the oral route . Furthermore, no systemic effects were reported in an vivo skin irritation study in rabbits with the source substance (p-anisic acid) and a similar property is expected for sodium anisate. Therefore, testing acute dermal toxicity should be avoided for reasons of animal welfare.