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Alchisor TAL 111 isdecene, hydroformylation products, 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 constituent 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. The most relevant and reliable study result from across the analogue/constituent categories has been identified and used to address the endpoint in question. Below is a brief summary of the endpoints associated with aquatic toxicity.

There was no reliable toxicity data for aquatic plants therefore a waiver is applied for that endpoint. 

 

Short-term Toxicity to Fish

The short-term toxicity in fish of constituent category substances of Alchisor TAL 111 has been documented within this dossier. Adequate reliable measured data exists for short-term toxicity to fish of constituent category substances of Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics or Category 3 hydrocarbon solvents)). The most sensitive study result across the Category 3 hydrocarbon solvents for this endpoint has been identified in a reliable study with C10 -C13 hydrocarbons (n-alkanes, isoalkanes, cyclics and aromatics (2 -25%) (Shell, 1997) which reports an LL50 for short term toxicity in fish of 10 -30 mg/L. Consequently, following the conservative approach outlined above, this range of values will be taken as the short-term toxicity in fish endpoint for Alchisor TAL 111.

 

Long-term Toxicity to Fish

The long-term toxicity in fish of components of Alchisor TAL 111 has been documented within this dossier.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. Using the 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-C10 are 0.079mg/L, 0.097 mg/L, 0.161 mg/L, and 0.288 mg/L, respectively.

In addition, 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.

In summary, the NOELR of 0.079 mg/L for C11-C14 hydrocarbons is the most sensitive study result and will be used for this assessment. Further assessment, due to ready biodegradability of the analogue and constituent category substances, is not necessary.

 

Short-term Toxicity to Invertebrates

Adequate reliable measured data exists for short-term toxicity to invertebrates of the analogue substance (Alchisor TAL 123) and the constituent category substances of Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics or Category 3 hydrocarbon solvents)) has been documented within this dossier. The mostrepresentative and relevant study is provided by the analogue substance, Alchisor TAL 123.Daphnia magna(D. magna) were exposed to the soluble components of Alchisor TAL 123 in an acute (48 hour) aquatic toxicity test (ENVIRON, 2012). The test endpoint (immobilisation) was estimated using the initial mass loading of the test material, i.e., the median Effective Loading (EL50) value. Test endpoints were expressed as the WAF of the nominal initial loading rate of the test product. The EL50 for short-term toxicity in aquatic invertebrates of 43.3 mg/L is taken as the most representative and relevant value for Alchisor TAL 111 based on the testing of the water soluble components of the analogue substance Alchisor TAL 123.

 

Long-term Toxicity to Invertebrates

The long-term toxicity in invertebrates of components of Alchisor TAL 111 has been documented within this dossier. One reliable (Klimisch 1) long-term toxicity study result for invertebrates was available for C9-C14 aliphatics (2-25% aromatics). The study, provided by Exxon Biomedical Sciences, Inc (2005), was a GLP compliant OECD 211 study with Hydrocarbons (C9 -C14 aliphatics (2 -25% aromatics)) andDaphnia magnawere exposed for 21 days to nominal loading concentrations of the test chemical. The EL10 based on reproduction was 0.316 mg/l. The EC10 based on reproduction was 0.109 mg/l. Reproduction was more sensitive than growth and survival, resulting in a NOELR of 0.28 mg/l and a NOEC of 0.097 mg/l.

In addition, 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.

In summary, theNOELR of 0.28 mg/lforC9 -C14 aliphatics (2 -25% aromatics) is the most sensitive study result andis considered to be directly comparable with NOELR reported for fish and algae, consequently this value will be taken as the long-term toxicity to aquatic invertebrate endpoint for Alchisor TAL 111.Further assessment, due to ready biodegradability of the analogue and constituent category substances, is not necessary.

 

Toxicity to Aquatic Algae

Study data for each analogue/constituent category has been evaluated and considered together. Four reliable (Klimisch 1) short-term toxicity studies in algae have been conducted for analogue/constituent categories of Alchisor TAL 111 (namely, Alchisor TAL 123 and C9 -C14 aliphatics (2 -25% aromatics)), and are included in this dossier. In accordance with the approach described in the 'Read-Across Justification' Report in section 13, the most reliable and relevant study result from across the analogue/constituent categories is the Alchisor TAL 123 algal study (ENVIRON, 2012) and used to address the hazard endpoint in question.

The freshwater algaePseudokirchneriella subcapitatawas exposed to the soluble components of alkenes, C1112, hydroformylation products, low boiling (Alchisor TAL 123) in an acute and chronic (72 hour) aquatic toxicity test (ENVIRON, 2012). The estimated 72 hourP. subcapitataEL50 for Alchisor TAL 123 is 14.6 mg/L WAF (95% confidence interval 11.7 to 30.0 mg/L WAF) as modified for water-insoluble substances. The equivalent NOELR is 3.75 mg/L (WAF). This value is taken as the toxicity in aquatic algae endpoint for Alchisor TAL 111.

Toxicity to Microorganisms

Four reliable (Klimisch 2) toxicity studies in microorganisms have been conducted for constituent categories of Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics)) and are included in this dossier. The studies are all predicted results using a QSAR approach. In a conservative approach the most sensitive study result from across the hydrocarbon studies (CONCAWE, 2010) is used to address the hazard endpoint in question.

CONCAWE (2010) predicted the toxicity of C9 -C14 aliphatics (2 -25% aromatics) to microorganisms using PetroTox in a QSAR approach. The estimated 48-hr EL50 values, based on growth inhibition, for the protozoan,Tetrahymena pyriformis, for C11-C14, C9-C10, C8-C12, and C10-C13 hydrocarbons are 185.1 mg/L,12.18 mg/L, 34.69 mg/L, and 63.75 mg/L, respectively. The estimated 48-hr NOELR (No Observed Effect Loading Rate), based on growth inhibition for C11-C14, C9-C10, C8-C12, and C10-C13 hydrocarbons are 1.71 mg/L, 1.53 mg/L, 1.12 mg/L, and 1.59 mg/L, respectively. The most sensitive NOELR of 1.12 mg/L for C8-C12 hydrocarbons is taken as representative of the toxicity to microorganisms endpoint for Alchisor TAL 111.

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