Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

No data available

Additional information

JUSTIFICATION FOR DATA WAIVING: Terrestrial organisms
No relevant studies on terrestrial organisms are available for the substance.
According to Regulation (EC) 1907/2006, Annex IX, Section 9.4.1 to 9.4.3, Column 2, studies on the toxicity to terrestrial organisms do not need to be conducted as the substance is considered to be readily biodegradable. The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected.
In Annex X Section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as hazardous according to Regulation EC 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB.
The hazard assessment of the substance reveals neither a need to classify the substance as hazardous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Based on the low measured and estimated BCF values, bioaccumulation in (aquatic) organisms is not to be expected (see IUCLID Ch. 5.3.1).
Consequently, no tests on soil organisms are performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX and X, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.


 


JUSTIFICATION FOR DATA WAIVING: Toxicity to birds


No studies on the long-term reproductive toxicity to birds are available for the substance.


In Annex X Section 9.6.1 of Regulation (EC) No 1907/2006, it is laid down that any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. In case of morpholine (CAS 110-91-8) a mammalian dataset is available. In addition, the hazard assessment of the substance reveals neither a need to classify the substance as hazardous according to Regulation EC 1272/2008 and its second adaptation 286/2011, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.


The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. Based on the low measured and estimated BCF values, bioaccumulation in organisms is not to be expected (see IUCLID Ch. 5.3.1). 


Hence, secondary poisoning is of no concern. 


Therefore, and for reasons of animal welfare, no tests on birds are performed.