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Short-term toxicity to aquatic invertebrates

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Description of key information

The short-term toxicity in invertebrates of Alchisor TAL 123 has been evaluated using a reliable new experimental study. Alchisor TAL 123 is of low water solubility and test solutions were prepared according to OECD water accommodated fractions (WAF) procedure to assess toxicity due to water soluble components of the test substance. Daphnia magna were exposed to the soluble components of Alchisor TAL 123 in an acute (48 hour) aquatic toxicity test. The median Effective Loading (EL50) value for immobilisation was estimated using the initial mass loading of the test material, with a low-level total organic carbon (TOC) analysis used for dose verification. The estimated 48 hour D. magna EL50 for the WAF of Alchisor TAL 123 is 43.3 mg/L WAF (95% confidence interval 38.0 to 48.7mg/L WAF) as modified for water-insoluble substances. While loading rate studies can be used for classification they cannot, however, be used for PNEC derivation (REACH endpoint guidance, chapter 7b); therefore, the substance has been further evaluated using adequate reliable measured data for short-term toxicity to invertebrates to components of Alchisor TAL 123 (namely, Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol). In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the hazard endpoint in question. The most sensitive measured study result from across the three substances has been identified as a reliable study with dodecan-1-ol (Laboratory of Pharmacology and Toxicology, 1997) which reports an EC50 for short-term toxicity in aquatic invertebrates of 0.765 mg/L. Consequently this value will be taken as the short-term toxicity in aquatic invertebrates endpoint for Alchisor TAL 123.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
0.765 mg/L

Additional information

The short-term toxicity in invertebrates of Alchisor TAL 123 has been evaluated using a reliable new experimental study. Alchisor TAL 123 is of low water solubility and test solutions were prepared according to OECD water accommodated fractions (WAF) procedure to assess toxicity due to water soluble components of the test substance. While loading rate studies can be used for classification they cannot, however, be used for PNEC derivation (REACH endpoint guidance, chapter 7b); therefore, the substance has been further evaluated using adequate reliable measured data for short-term toxicity to invertebrates to constituents of Alchisor TAL 123. The three constituents pertaining to Alchisor Tal 123 include the following: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol. Study data, where available, for each constituent has been evaluated and considered together. Several reliable (Klimisch 1 or 2) short-term toxicity studies in invertebrates have been conducted for components of Alchisor TAL 123 (namely, Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol) and are included in this dossier. The reliable studies included for each Alchisor TAL 123 constituent are briefly described below. In a protective approach the most sensitive study result from across the three constituents will be identified and used to address the hazard endpoint in question.

Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Two reliable (Klimisch 1) short-term toxicity studies for invertebrates were available for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), both of which are provided by Shell Research and Technology Centre. The Shell Research and Technology Centre (1995) conducted a reliable (Klimisch 1) GLP compliant OECD 202 study with low aromatic white spirit (identified as hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)) with Daphnia magna where the 48-hr LL50 was reported as 100 -200 mg/l. The Shell Research and Technology Centre (1997) conducted a reliable (Klimisch 1) GLP compliant OECD 202 study with low aromatic white spirit (identified as hydrocarbons, C10-C13, C8-C12 & C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)) with Daphnia magna, where the 48-hr EL50 for was reported as 10 -22 mg/l, which is the most sensitive study result for short-term toxicity to invertebrates for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%).

Undecan-1-ol

Three reliable (Klimisch 1 or 2) short-term toxicity studies for fish were available for undecan-1-ol. These include studies by Bengtsson (1984), Fisk et al., (2009), and Veith et al., (1983). Bengtsson et al., (1984) reported on a static acute toxicity test in Alburnus alburnus with undecan-1-ol and reported a 96hr LC50 to be 4.6 mg/L. Fisk et al. (2009) provided an estimate of short term toxicity of undecan-1-ol which was predicted using a multiple partitioning model where the predicted LL50 is 1.7 mg/L. Veith et al., (1983) provided short-term toxicity results for exposure to undecan-1-ol to the fish,Pimephales promelas.Undecan-1-ol was administered at 5 nominal concentrations in a range pre-determined to obtain 0 and 100% mortality (specific dose regimen not reported). The 96hr LC50 was calculated using the trimmed Spearman-Karber method at 1.04mg/L for undecan-1-ol. This value is the most sensitive result of the three reliable short-term studies with undecan-1-ol.

Dodecan-1 -ol

Three reliable (Klimisch 2) and one secondary source (Klimisch 4) short-term toxicity studies for invertebrates were available for dodecan-1-ol. Begntsson et al., (1984) exposed copepod, Nitocra spinipes to dodecan-1 -ol and provided a 96hr LC50of 1mg/L. P&G (1996) conducted a reliable (Klimisch 2) GLP compliant OECD 202 study exposing Brachionus calyciflorus, a rotifer, in two tests for 48 hours resulting in LC50s of 0.81 and 0.88 mg/L. Henkel (1999) provided a summary report of D. magna exposure to dodecan-1-ol with a resulting 48 hr EC50 of 320 mg/L. Laboratory of Pharmacology and Toxicology (1997) conducted a reliable OECD 202 study where Daphnia magna were exposed to dodecan-1-ol for 48 hours resulting in a 48 hr LC50 of 0.765 mg/L. The result of 0.765 mg/L is the most sensitive short-term toxicity to invertebrates for exposure to dodecan-1-ol

Alchisor TAL 123

A short-term toxicity to aquatic invertebrates study performed to GLP standards in accordance with the OECD Guideline 202 is available for Alchisor TAL 123. The freshwater cladoceran Daphnia magna (D. magna) was exposed to the soluble components of Alchisor TAL 123 in an acute (48 hour) aquatic toxicity test. The test substance is of low water solubility and, following a range finding test, a test concentration series of WAF preparations of 3.75, 7.5, 15, 30, and 60 mg/L nominal loading rates of alkenes, C11‐12, hydroformylation products, low boiling were prepared. This test material preparation is designed to specifically assess toxicity due to the water soluble components of the test compound, reducing the potential for effects due to physical (as opposed to chemical) impacts on the test organisms. The test endpoint (immobilization) 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; a low-level total organic carbon (TOC) analysis was used for dose verification.

The estimated 48 hour D. magna EL50 for the WAF of alkenes, C11‐12, hydroformylation products, low boiling is 43.3 mg/L WAF (95% confidence interval 38.0 to 48.7mg/L WAF) as modified for water-insoluble substances.

Conclusion

The short-term toxicity in invertebrates of Alchisor TAL 123 has been evaluated using a reliable new experimental study. Alchisor TAL 123 is of low water solubility and test solutions were prepared according to OECD water accommodated fractions (WAF) procedure to assess toxicity due to water soluble components of the test substance. The estimated 48 -hour D. magna EL50 for the WAF of Alchisor TAL 123 is 43.3 mg/L (95% confidence interval 38.0 to 48.7 mg/L WAF) as modified for water-insoluble substances. While loading rate studies can be used for classification they cannot, however, be used for PNEC derivation (REACH endpoint guidance, chapter 7b); therefore, adequate reliable measured data have been used to evaluate short-term toxicity to invertebrates of Alchisor TAL 123 components (namely, Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1 -ol and dodecan-1 -ol). In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the hazard endpoint in question.The most sensitive measured study result from across the three substances has been identified as a reliable study with dodecan-1-ol (Laboratory of Pharmacology and Toxicology, 1997) which reports an EC50 for short-term toxicity in aquatic invertebrates of 0.765 mg/L. Consequently this value will be taken as the short-term toxicity in aquatic invertebrates endpoint for Alchisor TAL 123.