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Long-term toxicity to fish

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Description of key information

The following study are available  for the long-term toxicity to fish endpoint and are included in support of the argument for the omission of this study:
De Vries et al (1991) Comparative toxicity of organotin compounds to rainbow trout (Oncorhynchus mykiss) yolk sac fry, The Science of the Total Environment, 103.(1991) 229-243.
The study has been given a Klimisch score of 4as it is a non-guideline, non-GLP study.

Key value for chemical safety assessment

Additional information

De Vries et al (1991) was provided as supplementary information concerning the long-term toxicity of the substance in fish. The study was assigned a reliability score of 4 (not assignable) as a number of key points within the data were not reported, as such the level of documentation was considered insufficient for accurate assessment of the data presented.

The comparative toxicity of various organotin compounds was investigated in early life stages of the rainbow trout. Beginning with yolk sac fry, trout were continuously exposed for 110 days to dibutyltin chloride (DBTC) at 160-4000 nM. For DBTC a no-observable-effect concentration (NOEC) of 160 nM was established, corresponding to 40 ppb. Tail melanization was observed in the groups exposed to 800 nM DBTC. At the end of the exposure period, resistance to infection was examined by an intraperitoneal challenge with Aeromonas hydrophila ,a secondary pathogenic bacterium to fish. Resistance of bacterial challenge was found to be decreased even at the lowest-effect concentration of DBTC.

No value has been allocated for the chemical safety assessment and in accordance with column 2 of REACH Annex IX, the long-term testing on fish study does not need to be conducted as the chemical safety assessment concludes that the substance is of no immediate concern to the environment. The available data are adequate for classification and labeling purposes and PBT assessment, so no further testing is required.