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Long-term toxicity to fish

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Description of key information

Key value for chemical safety assessment

Additional information

Due to the rapid hydrolysis of the substance, the chemical safely assessment is based on the silanol hydrolysis product 3-aminopropylsilanetriol.

Testing for long-term toxicity to fish is not considered necessary because:

 

In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that further testing is not justified for the following reasons:  

 

The substance has acute data available for three trophic levels, as well as chronic invertebrate and algal toxicity data. Based on this available aquatic data the most sensitive trophic level in the short-term tests was invertebrates, but the most sensitive trophic level in the long-term tests was for algae.  Furthermore, no effects were observed in the short-term toxicity to fish test even when the substance was tested at high nominal concentrations approaching 1000 mg/l.

 

An assessment factor of 50 was applied to derive the freshwater PNEC using the long-term algae result. The availability of the long-term result covering the most sensitive species in the aquatic tests, and the application of an appropriate assessment factor, means it is, therefore, unlikely that the aquatic PNEC would be significantly over-estimated. A PNEC has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.

 

The substance is highly water-soluble, has low bioavailability based on log Kow <3 (-4.0 (corrected for ionisation)), especially in pH neutral conditions, and evidence from data available within the analogue group of amine substances suggests that fish are the least sensitive trophic level.

 

Overall it is concluded that the risk is adequately assessed using the short-term data and the long-term invertebrate test, and that in vivo testing on vertebrate animals is not considered necessary or justified on ethical grounds.

 

Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.