Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

According to regulation (EC) No 1907/2006, Annex XI, paragraph 1.5., substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). The substance consists of two main components, a component with a C18 chain (60%) and C16 chain (30%) component. The structure of both substances is the same except the chain length. The substance with C18 is already notified under EC 445-990-9. It is expected that the structural difference between the octadecanoate and the hexadecanoate does not affect the physico-chemical properties, the toxicological and ecotoxicologocal profile as well as the environmental fate. It can be stated that both substances have a low water solubility and a high log Pow indicating bioaccumualtion potential. Furthermore, it can be assumed that the degradation products of EC 445-990-9 are very similar to the degradation products of the mixture containing the octadecanoate and the hexadecanoate. Therefore read-across to EC 445-990-9 is scientifically justified for physico-chemical properties, the toxicological and ecotoxicologocal profile as well as environmental fate.


Short description of key information:
The substance was found negative in an Ames test performed under GLP and according to guidelines (RCC, 848430, 2003) and negative in a chromosomal aberration test performed under GLP and according to guidelines (RCC, 848431, 2003). The substance is therefore considered negative for genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.   

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No. 1272/2008.