Calcium di(octanoate)

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 skin contact in production and/or use is not likely

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

The substance is formed during the industrial process (it is a soap) and therefore there is no exposure via inhalation nor dermal.

Column 2 of Annex VIII 8.5 states: "In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided."

The substance (soap) is formed within the production tank of the grease (mixture). This tank is closed, this process requires heating, the workers will not get in contact with the product whilst it is still hot. However at the end of the production a sample of the grease (mixture) is taken in order to do some analysis. Contact would be essentially by hand however workers would be required to wear PPE in order to minimise the risk of exposure.
Towards the end of the process, some workers could be in contact with the product during grinding, deaeration, and packaging. Again contact would essentially be by hands and again workers would be required to wear PPE (chemical gloves and safety glasses).

There is no exposure via the dermal route and therefore an acute toxicity dermal study is not considered to be necessary. Furthermore, published results of studies used to assess the dermal toxicity of a number of read-across substances have indicated that there is no toxicity via the dermal route. Based on similarities in structure and properties it can be concluded that exposure via the dermal route is unlikely to result in toxic effects.