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Sediment toxicity

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In Annex X, Section 9.5.1, of Regulation (EC) No 1907/2006, it is laid down that chronic tests on sediment organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on sediment 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 shows that the substance is neither PBT nor vPvB. Based on the harmonised classification, the substance is classified as aquatic chronic 2. However, the classification is probably based on the NOEC of the algae growth inhibition study by NITE (NOEC = 0.36 mg/L). Based on a re-evaluation of the test data, a 72-h ErC10 of 4.1 mg/L was derived. According to the Guidance on information and safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment “an EC10 for a long-term test which is obtained using an appropriate statistical method (usually regression analysis) will be used preferentially. […] There has been a recommendation within OECD in 1996 to phase out the use of NOEC, in particular as it can correspond to large and potentially biologically important magnitudes of effect. The advantage of regression method for the estimation of ECx is that information from the whole concentration-effect relationship is taken into account and that confidence intervals can be calculated. These methods result in an ECx, where x is a low effect percentile (e.g. 5-20%). It makes results from different experiments more comparable than NOECS”. Therefore, it can be concluded that there is no need to classify the substance as dangerous to the environment.

Sediment is not a compartment of concern. The measured log Koc and the measured log Kow of the substance are below 3; therefore, a low adsorption potential is indicated (see IUCLID Ch. 5.4.1). Hence, an adsorption to activated sludge in the STP, suspended matter or sediment particles is unlikely. Based on the low log Kow and the low measured BCF value, bioaccumulation in aquatic organisms is not to be expected for the substance and its degradation products (see IUCLID Ch. 5.3.1 and 5.2.1). As a consequence, a transfer to the sediment compartment is unlikely. The calculated environmental distribution indicates that the substance will be mainly present in the compartment water (> 95%) and to a minor part in the sediment (1.5%; see IUCLID Ch. 5.4.3).

In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10). Consequently, no test on sediment organisms is performed. The equilibrium partitioning method has been used for assessing the hazard to sediment organisms. 

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