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Long-term toxicity to fish

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Description of key information

The long-term toxicity in fish of components of Alchisor TAL 111 has been documented within this dossier. There was not adequate reliable measured data for the long-term toxicity to fish to components of Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics), although reliable predicted data for C9 -C14 aliphatics (2 -25% aromatics) existed (Redman 2010) and provides an estimated NOELR of 0.079 mg/L. Consequently this value will be taken as the long-term toxicity in fish endpoint for Alchisor TAL 111 as a conservative approach.  

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.079 mg/L

Additional information

Alchisor TAL 111 is decene, hydroformylation product, low boiling and can be characterised as a UVCB substance. As defined in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substance Alchisor TAL 123 and the Alchisor TAL 111 consitutent category substances, Category 3 hydrocarbon solvents, are representative of Alchisor TAL 111 and suitable for assessment purposes. Study data for each analogue/constituent category has been evaluated and considered together. Four reliable (Klimisch 1) long-term toxicity studies in fish have been conducted for constituent categoriesof Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics)), although no studies are available for the analogue substance, Alchisor TAL 123, and are included in this dossier. In a conservative approach the most sensitive study result from across the constituent categories will be identified and used to address the hazard endpoint in question.

 

C9-C14 aliphatics (2-25% aromatics)

Although there are no reliable measured data for long-term fish studies relating to the toxicity of C9-C14 aliphatics (2 -25% aromatics), reliable (Klimisch 2) predicted results using a QSAR, PetroTox computer model are available. PetroTox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism. As per ECHA Guidance Chapter 6, the use of QSARs is acceptable for filling data gaps needed for hazard assessment. In addition, supporting information for the use of QSAR modelling is presented in the CONCAWE report (Lampi et al., 2010), which is also included in Section 13 of the CSR. The CONCAWE report states that QSAR modelling was used for assessment of persistence and bioaccumulation for the PBT assessment.Using the Petrotox model, Redman (2010) estimated the freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value, based on growth, for four hydrocarbon groups. The NOELRs for C11-C14, C10-C13, C8-C12, and C9-C10are 0.079mg/L, 0.097 mg/L, 0.161 mg/L, and 0.288 mg/L, respectively. The NOELR of 0.079 mg/L for C11-C14 is the most sensitive and will be used for this assessment.    

 

Biodegradation

In accordance with the technically robust approach defined in the 'Read-Across Justification' report in section 13, the most reliable and relevant study results from the analogue/constituent categories is applied to the Alchisor TAL 111 biodegradation endpoint. The analogue substance, Alchisor TAL 123 is determined to be readily biodegradable in a reliable (Klimisch 1), GLP compliant OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test) study. In this test Alchisor TAL 123 biodegraded to an extent of 78.38% after 28 days with an unacclimated sewage sludge inoculum. It was concluded that Alchisor TAL 123 is readily biodegradable, although failed the 10 -day window. In addition, the representative constituent categories of Alchisor TAL 111 (i.e., C9 -C14 aliphatics (2 -25% aromatics)) are reported to be readily biodegradable. In a GLP-compliant OECD 301F study, the test substance Shellsol H biodegraded to an extent of 74.7% after 28 days with a sewage sludge inoculum. The test substance was determined to be readily biodegradable.

Reliable studies indicate that both the analogue substance, Alchisor TAL 123, and the constituent categories, C9 -C14 aliphatics (2 -25% aromatics), of Alchisor TAL 111 are readily biodegradable. In the environment, ready biodegradability means that it is unlikely that aquatic life will be exposed to Alchisor TAL 111 over extended periods, with low potential to exert long-term toxic effects.

 

The long-term toxicity in fish of components of Alchisor TAL has been documented within this dossier. There was not adequate reliable measured data for the long-term toxicity to fish to components of Alchisor TAL (namely, C9 -C14 aliphatics (2 -25% aromatics), however, reliable (Klimisch 2) predicted data for C9 -C14 aliphatics (2 -25% aromatics) existed (Redman, 2010) and provides an estimated NOELR of 0.079 mg/L. Following the approach described in the 'Read-Across Justification' report this value will be taken as the long-term toxicity in fish endpoint for Alchisor TAL 111. Further assessment is not necessary.

References:

Lampi et al. 2010. An Evaluation of the Persistence, Bioaccumulation and Toxicity of PetroleumHydrocarbonsPrepared for CONCAWE March 2010.

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