Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

No studies are available with information on toxicity to soil microorganisms, soil macroorganisms and arthropods, and birds. 

 

In Accordance with REACH 9.4 Annex IX, column 2, studies on effects on terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. As direct exposure of the soil and indirect exposure of the soil via sewage treatment plants is not expected, no short-term or long-term toxicity testing on invertebrates and microorganisms must be conducted.

 

Moreover, long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicate 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. Apart from its explosive properties, nitroguanidine is not classified as hazardous. Nitroguanidine is practically non-toxic to aquatic vertebrates and invertebrates, plants, and microorganisms. Furthermore, nitroguanidine is not expected to accumulate in soil to any extent. Therefore, nitroguanidine poses no hazard to soil (-dwelling) organisms. Therefore, no long-term toxicity testing of soil organisms is required.

 

Furthermore, nitroguanidine is practically non-toxic to mammals (acute oral toxicity LD50 4345 mg/kg bw; not irritating to skin; 90 d oral toxicity NOAEL > 1000 mg/kg/d; not mutagenic or carcinogenic; reproductive toxicity NOAEL > 1000 mg/kg/d; not teratogenic; developmental toxicity NOAEL 316 mg/kg/d). No environmental emission of nitroguanidine to the soil is expected. Due to the physicochemical properties of nitroguanidine, no secondary poisoning of birds is expected, either through the consumption of fish or the consumption of earthworms. As such, it is unlikely that nitroguanidine would pose a significant risk to birds; consequently, there is no need to test the long-term or reproductive toxicity of nitroguanidine to birds.

 

One study is available on toxicity on terrestrial plants. Nitroguanidine was applied to soybeans (Glycine max) in hydroponic culture at concentrations of 0, 2, or 4 mM nitroguanidine as well to soybeans and grasses (Festuca arundinacea) grown in soil treated with 100 mL of either 0, 2, 4, 6, and 8 mM nitroguanidine solutions by applying the solution directly to the soil on alternate days for a total of 5 applications.

After 14 d the application of nitroguanidine led to chlorotic leaves in soybeans grown in hydroponic cultures and in soil cultures at a concentration of 2mM. In both grass species tested (smooth bromegrass and tall fescue, grown in soil cultures), which are less sensitive to nitroguanidine than soybeans, displayed signs of toxicity at concentrations of 4 mM nitroguanidine.

The results of this study indicate that nitroguanidine is toxic towards the soybeans and grass species tested. As direct and indirect exposure of the soil compartment is unlikely, these results only display the potential risk of nitroguanidine but not the actual risk of the test substance.