Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with Regulation (EC) No 1907/2006, Column 2 of Annex IX and X, section 9.4 toxicity tests on terrestrial organisms does not need to be investigated if the outcome of the chemical safety assessment shows no indication of risk on terrestrial organisms from exposure to the substance in question. In a first step, the soil PNEC for methylcyclohexane has been derived using aquatic PNECs and the equilibrium partitioning method (EqP). The risk characterization ratio (RCR) has demonstrated that there is no indication of risk i.e. PEC/PNEC soil < 1 from current exposure conditions to methylcyclohexane.

Furthermore, considering the high volatility, the substance is expected to be rapidly removed within sewage treatment plants. As a consequence, direct and indirect exposure of soil organisms is unlikely to occur. In addition, due to the high volatility, it is unlikely that a constant exposure concentration could be achieved in soil toxicity tests.

In conclusion, in accordance to Regulation (EC) No. 1907/2006, Annex IX and X, Column 2, 9. 4, as the RCR soil is < 1 no further effects of methylcyclohexane on terrestrial organisms need to be investigated and tests are therefore not required.

Furthermore, studies on long-term or reproductive toxicity to birds studies do not need to be conducted due to the existence of a large mammalian dataset demonstrating low toxicity to higher organisms.