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EC number: 620-056-5 | CAS number: 874195-61-6
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further toxicity testing with terrestrial organisms.
Key value for chemical safety assessment
Additional information
In accordance with Annex IX, column 2 of Regulation (EC) No 1907/2006, toxicity testing with terrestrial organisms does not need to be conducted as the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate a need for further investigations.
Triafamone (CAS 874195-61-6) has a low adsorption potential due to a log Koc of 1.9 – 2.0 (OECD 106). According to the structure, the substance is not expected to fulfill the stringent criteria of a ready biodegradation test. However, under environmental conditions the substance will degraded rapidly with half-lives less than 10 days (OECD 308, OECD 307). The NOEC for aquatic algae is 0.096 mg/L (nominal). Thus, according to Guidance on information requirements and chemical safety assessment, R.7c (ECHA, 2017) triafamone (CAS 874195-61-6) is in “Hazard category 2”.
Terrestrial toxicity tests for triafamone are available for short-term toxicity to soil macroorgansims (earthworm Eisenia fetida), toxicity to terrestrial arthropods (honey bee Apis mellifera) and soil organisms (nitrogen and carbon transformation). The earthworm Eisenia fetida shows no morphological and behavioural effects during the 14 days test duration. Mortality was not observed 8oder so ähnlich. The study according to OECD guideline 207 and GLP resulted in a LC50 (14d) of > 1000 mg/kg soil dw. In both tests with honey bees (acute contact and acute oral), no significant mortality occurred in the water and solvent controls and no behavioural or other biological effects were observed. Therefore, the LD50 (48 h) for the contact toxicity test was > 100 µg a.i./bee and the LD50 (48 h) for the oral toxicity test was > 55.8 µg a.i./bee. The test with soil microorganisms caused no effects above the trigger value of 25% deviation from the control. Thus, all available terrestrial toxicity tests show no effects on terrestrial organisms.
In addition, according to Annex IX, column 2 of Regulation (EC) No 1907/2006 toxicity testing with terrestrial organisms does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. As no sludge application to land from exposed STPs is given, aerial deposition are negligible and the relevance of other exposure pathways such as irrigation and/or contact with contaminated waste is unlikely, soil exposure will not occur for triafamone (CAS 874195-61-6) according to the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2017). Only manufacture or formulation in closed batch processes are given in the chemical industry for this substance or transfer of the substance or the mixture (Charging and discharging) is a manufacture process. Thus, no further terrestrial toxicity test for terrestrial plants needs to be conducted.
The PNEC (soil) was derived on the basis of the short-term toxicity test with Eisenia fetida and on the basis of the outcome of the aquatic toxicity data for evaluation of the PEC/PNEC ratio. The calculation with the equilibrium partitioning method (EPM) resulted in a lower PNEC soil and therefore in a larger PECsoil/PNECsoil ratio. Thus, the PNEC derived by EPM represents the worst case and is considered to be more relevant. This screening assessment indicates no risk for the terrestrial compartment (RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Thus, according to Guidance on information requirements and chemical safety assessment, R.7c (ECHA, 2017), no toxicity testing for terrestrial plants needs to be done.
Overall, due to a low potential for adsorption, terrestrial toxicity tests showing no effects, unlikely direct and indirect exposure and no risk for the terrestrial compartment (RCR < 1) in the screening assessment, no toxicity testing for terrestrial plants needs to be conducted.
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