Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Alchisor TAL 145 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-1 -ol. As defined in the Read-Across Justification Document in section 13, data provided for these constituents when considered together is representative of Alchisor TAL 145 and suitable for assessment purposes. Study data for each constituent has been evaluated and considered together. In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the endpoint in question. Measured short-term toxicity data are available for terrestrial organism exposure to tetradecan-1 -ol, although no short-term data are available for dodecan-1-ol or Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). These short-term toxicity data are used in PNEC derivation using the assessment factor approach. For completeness, supporting information is provided for dodecan-1-ol and tetradecan-1-olwhere equilibrium partitioning method has been used to derive a PNECsoil from the respective PNECfreshwater. In summary, the requirement for further toxicity testing of Alchisor TAL 145 to soil organisms is waived.

Predicted No Effect Concentration (PNEC)

Short-term toxicity test data are available for soil dwelling organisms (specifically, earthworm, springtail and nematode). The lowest EC50 value reported is 530 mg/kg d.w. soil (1.3% organic carbon). An assessment factor of 1000 is applied to derive a PNECsoil of 0.72 mg/kg w.wt. soil (2% organic carbon). ECHA guidance recommends that where few data are available, they are compared with a PNEC derived from predicted data using the equilibrium partitioning (EqP) model, which is 0.28 mg/kg w.wt. The lower value is taken as the most precautionary approach; therefore the PNECsoil is 0.28 mg/kg w.wt.

 

Toxicity to Macroorganisms and Arthropods

Measured and reliable data consisting of three short-term toxicity studies using tetradecan-1-ol were available for these endpoints; all studies related to a single study report (Shell, 2004). A reliable 7 day EC50 value of 530 mg/kg dw soil (1.3% organic carbon) has been determined for the effects of tetradecan-1-ol on population numbers ofFolsomia candida (springtail). This is the key study reflecting the lowest toxicity value from the three effect concentrations Similar data forEisenia fetida (earthworm) andCaenorhabditis elegans (nematode) reported EC50s of >1,000 mg/kg (d.w.;1.3% organic carbon). The equilibrium partitioning approach has been taken for the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) with the most conservative HC5 of 0.116 mg/kg (w.wt.) representing a C12 carbon chain length hydrocarbon.

 

The requirement for long-term data for these soil organisms is waived on the basis that in the environment, the ready biodegradability of Alchisor TAL 145 and its constituents means it can be assumed that the substance will be biodegraded within the STP process and as a consequence a transfer to the soil compartment via sewage sludge is not expected. In addition, considerable technical difficulties would be expected in the conduct of long-term tests, due to very rapid biotic removal of the substance from the test system (based on experience in the long-term aquatic invertebrate study).

 

Toxicity to Micro-organisms

In accordance with Column 2 of REACH Annex IX, the toxicity test with terrestrial microorganisms (required in Section 9.4.2) does not need to be conducted as direct and indirect exposure of the soil compartment is unlikely. In the absence of toxicity data for soil microorganisms, measured and reliable toxicity data relating to macroorganisms and arthropods following short-term exposure to tetradecan-1-ol is used in the PNEC derivation for soil organisms. In addition, the equilibrium partitioning method has been applied to assess the hazard to all soil organisms from Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). The requirement for toxicity data for soil microorganisms is waived on the basis that in the environment, the ready biodegradability of Alchisor TAL 145 and its constituents means it can be assumed that the substance will be biodegraded within the STP process and as a consequence a transfer to the soil compartment via sewage sludge is not expected. In addition, considerable technical difficulties would be expected in the conduct of long-term tests, due to very rapid biotic removal of the substance from the test system (based on experience in the long-term aquatic invertebrate study).

 

Toxicity to Terrestrial Plants

In accordance with Column 2 of REACH Annex X, long-term toxicity testing with terrestrial plants (required in Section 9.4.5) is not needed as the chemical safety assessment according to Annex I indicates that this is not necessary. Moreover, considerable technical difficulties would be expected in the conduct of such a test, due to the very rapid biotic removal of the constituent substances from the test system (based on experience in the long-term aquatic invertebrate study using tetradecan-1-ol).

 

Toxicity to Birds

In accordance with Column 2 of REACH Annex X, long-term and reproductive toxicity testing with birds (required in Section 9.6) is not necessary due to the evidence provided in the study by Yoshida & Hoshii (1971) to address avian survival and range of the mammalian reproductive studies indicates that Alchisor TAL 145 and its constituents are unlikely to present a hazard to birds. The additional evidence of ready biodegradability provided by reliable measured data for dodecan-1-ol, tetradecan-1-ol and Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) in the CSR Chapter 5 and the SIDS SIAR for Long Chain Alcohols (2006) means it can be assumed that Alchisor TAL 145 will be biodegraded within the STP process and as a consequence a transfer to the terrestrial compartment, including avian species, via sewage sludge is not expected. Therefore, no further tests on avian species are provided and the need for any further testing is waived.

 

The toxicity in soil organisms of components of Alchisor TAL145 has been documented within this dossier. There was adequate reliable measured data for the toxicity to soil organisms to components of Alchisor TAL 145 (namely, tetradecan-1-ol) and these were used in an assessment factor approach to derive a PNECsoil. For completeness, a no-effect concentration was predicted by the Long Chain Alcohols Consortium using the equilibrium partitioning approach, where the following PNECsoil were derived:

 

·        An equilibrium partitioning approach has been used to determine a PNECsoil for dodecan-1-ol of 0.888 mg/kg d.wt.;

·        An equilibrium partitioning approach has been used to determine a PNECsoil for tetradecan-1-ol of 0.28 mg/kg d.wt.; and

·        An assessment factor approach has been used to determine a PNECsoil for tetradecan-1-ol of 0.53 mg/kg d.wt. based on the lowest EC50 (the Folsomia candida study) in the experimental data reported in this dossier.

 

The most protective approach has been taken in this dossier and the indicative PNECsoil for Alchisor TAL 145 is therefore based on the equilibrium partitioning derived value of 0.28 mg/kg. Further testing with Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1ol or tetradecan-1-ol was deemed not necessary and is waived.