Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity to soil macroorganisms except arthropods

The 14-day LC50 estimation for earthworms exposed to the test substance in an artificial soil substrate was determined to be greater than 1000 mg/kg dry soil. The no-observed-effect-concentration (NOEC) was 500 mg/kg, based on reduced body weights in the 1000 mg/kg level.

There was no mortality of adult earthworms exposed to nominal concentrations of Reofos 35 at 62.5, 125, 250, 500, and 1000 mg/kg dry soil for 28 days. Based on body weight and survival data of adult earthworms, the no observed effect concentration (NOEC) was determined to be 1000 mg/kg dry soil, the highest concentration tested. There were no reductions of 50% or greater for the numbers of juveniles produced in the treatment groups in comparison to the pooled control group, therefore the EC50 for reproduction was greater than 1000 mg/kg dry soil, the highest concentration tested. The EC10 for reproduction was determined to be 172 mg/kg dry soil. The NOEC was 250 mg/kg dry soil and the LOEC was 500 mg/kg dry soil, based on the reduced number of juveniles produced.

 

Toxicity to terrestrial arthropods

In accordance with column 2 of REACH Annex X, Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment. The substance does not demonstrate effects in the 3 groups of terrestrial organisms assessed. Hence, it is considered unnecessary to test for this additional endpoint. The substance is not hazardous to terrestrial organisms.

 

Toxicity to terrestrial plants

Acute

The effects of Durad 310M, incorporated into soil at concentrations of 100, 10, 1 and 0 mg/kg, upon the germination (emergence) and growth of seedlings of wheat (Triticum aestivum), radish (Raphanus sativus)and mung bean (Phaseolus aureus) were determined over periods of 19, 18 and 19 days respectively, representing 14 days after at least 50% emergence of control seedlings.

 The LC50 for emergence and EC50 for growth rate were both greater than the highest concentration tested, 100 mg/kg, in all species.

 No phytotoxic effects were observed for any of the species tested.

 

Chronic

In accordance with column 2 of REACH Annex X, Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment.

 

Based on the lack of toxicity within the short term plant study, and the fact that no effects are noted in the other studies, it is proposed that a long term toxicity test in plants is not required. 

 

Toxicity to soil microorganisms

The long-term effects of the test substance on nitrogen transformation activity of soil microorganisms were minimal at concentrations 10, 32, 100, and 318 mg/kg dry soil. There was an observed effect of The test substance on nitrogen transformation activity of soil microorganisms at concentration level 1010 mg/kg dry soil. After 28 days of exposure, the mean nitrate concentration in soil treated at 10, 32, 100, 318, and 1010 mg/kg dry soil exhibited a -1%, 1%, 0%, 2%, and 23% reduction in nitrate formation, respectively, compared to the controls. The EC10 was calculated to be 582.7 mg/L using linear interpolation between concentrations 318 and 1010 mg/L. The EC25 and EC50 were estimated to be >1010 mg/L, the highest concentration tested.

 

Toxicity to birds

There is sufficient mammalian toxicology available on the substance to preclude the requirements to test for toxicity to birds. As such, this endpoint is waived on the grounds of animal welfare and sufficient information on toxicological properties being available to adequately assess the substance.