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Toxicity to birds

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Description of key information

In Annex X of Regulation (EC) No 1907/2006, it is laid down that the need for avian testing should be carefully considered by taking into account the large mammalian dataset that is usually available at this tonnage level. Studies with avian data for Alchisor TAL 111, its analogue substance TAL 123, or constituent categories C9-C14 aliphatics (2-25% aromatics) were not available. However, by way of comparison, the mammalian toxicity dataset for the analogue substance Alchisor TAL 123 was reviewed. A reliable (Klimisch 1 or 2) study was available for the C9-14 aliphatics (2-25% aromatics). An oral reproductivity study in rats (Sasol, 1995) was conducted with components of the C9-C14 aliphatics (2-25% aromatics) category. 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). It can be concluded that the reproductive toxicity evidence based on the components of Alchisor TAL 111 are unlikely to impair mammalian reproduction.
 
The evidence provided by the mammalian reproductive study indicates that Alchisor TAL 111 and its constituents are unlikely to present a hazard to birds. The additional evidence of ready biodegradability provided by reliable measured data for the analogue substance Alchisor TAL 123 and constituent categories, C9 -C14 aliphatics (2 -25% aromatics), in the CSR Chapter 5 means it can be assumed that Alchisor TAL 111 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.

Key value for chemical safety assessment

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. The most relevant and reliable study result from across the analogue/constituent categories has been identified and used to address the endpoint in question.However, no reliable measured data were available for the analogue substance or the constituent categories (C9-C14 aliphatics (2-25% aromatics)).

 

In Annex X of Regulation (EC) No 1907/2006, it is laid down that the need for avian testing should be carefully considered by taking into account the large mammalian dataset that is usually available at this tonnage level. Studies with avian data for Alchisor TAL 111, its analogue substance TAL 123, or constituent categories C9-C14 aliphatics (2-25% aromatics) were not available. However, by way of comparison, the mammalian toxicity dataset for the analogue substance Alchisor TAL 123 was reviewed. A reliable (Klimisch 1 or 2) study was available for the C9-14 aliphatics (2-25% aromatics). An oral reproductivity study in rats (Sasol, 1995) was conducted with components of the C9-C14 aliphatics (2-25% aromatics) category. 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). It can be concluded that the reproductive toxicity evidence based on the components of Alchisor TAL 111 are unlikely to impair mammalian reproduction.

 

The evidence provided by the mammalian reproductive study indicates that Alchisor TAL 111 and its constituents are unlikely to present a hazard to birds. The additional evidence of ready biodegradability provided by reliable measured data for the analogue substance Alchisor TAL 123 and constituent categories, C9 -C14 aliphatics (2 -25% aromatics), in the CSR Chapter 5 means it can be assumed that Alchisor TAL 111 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.

 

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