Fatty acids, C16-18, isononyl esters

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).
The target substance Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) did not cause mortality or adverse clinical signs in an acute toxicity study following oral administration of 5000 mg/kg bw in male and female Wistar rats. Furthermore, no systemic effects were noted in vivo skin irritation and skin sensitisation studies performed with the analogue substances Fatty acids, C16-18, isotridecyl esters (CAS 95912-88-2), Decyl oleate (CAS 3687-46-5), 2-ethylhexyl oleate (CAS 26399-02-0), 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), and Fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0).
Workers are not exposed due to a closed process system. Professionals/consumers exposure is expected to be very low due to the concentration of <2% in the preparation and absence of acute oral toxicity. Acute dermal toxicity is not considered relevant since the concentration of the target substance in the preparation is <2% throughout the supply chain.
Therefore, testing acute dermal toxicity should be avoided for reasons of animal welfare, especially as the substance is not classified as STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, isononyl esters

EC Number:

292-960-4

EC Name:

Fatty acids, C16-18, isononyl esters

Cas Number:

91031-57-1

Molecular formula:

not available - multi constituent substance

IUPAC Name:

Fatty acids, C16-18, isononyl esters