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Ecotoxicological information

Toxicity to birds

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Description of key information

Yoshida and Hoshii (1971) provides evidence  indicating that Alchisor TAL 123 and its constituents are unlikely to present a hazard to birds (LD50 = 176,000 mg/kg).  The additional evidence of ready biodegradability provided by reliable measured data for undecanol, dodecanol 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 123 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, the requirement for further testing of avian species is waived.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:
176 000 mg/kg food

Additional information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-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 123 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. Study data, where available, for each constituent has been evaluated. 

 

In Annex X of Regulation (EC) No 1907/2006, it is laid down that long-term or reproductive toxicity to birds shall be proposed by the registrant, although testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.

 

One study is available by Yoshida and Hoshii (1971) forGallus domesticus (chicken) where a reliable 21-day LD50value of 176,000 mg/kg has been determined for the effects of dodecanol on mortality. Full details of the study are not available and it is considered to provide supporting information for this endpoint. Studies with avian data for undecanol and Hydrocarbons C11 -C14 aliphatics, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%) were not available.

 

By way of comparison, the mammalian toxicity dataset for Alchisor TAL 123 was reviewed. A number of reliable (Klimisch 1 or 2) study information was available for the Hydrocarbons C11 -14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%), undecanol and dodecanol. An oral reproductivity study in rats (Sasol, 1995) was conducted with components of the Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%). In the absence of reproductive effects in both cases the NOAEL for reproductive toxicity was determined to be 1000mg/kg bw/day (the highest dose tested). In a dietary reproductivity study (Hansen, 1992) rats were exposed to dodecan-1-ol at levels equivalent to 100, 500, 2000mg/kg for 41-44 days (males), and up to 54 days (females). In the absence of any adverse reproductive effects the NOAEL was determined to be 2000mg/kg bw/day. It can be concluded that the reproductive toxicity evidence based on the components of Alchisor TAL 123 are unlikely to impair mammalian reproduction.

 

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 123 and its constituents are unlikely to present a hazard to birds. The additional evidence of ready biodegradability provided by reliable measured data for undecanol, dodecanol 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 123 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.