Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

The acute toxicity of Biofert Plusz towards Danio rerio was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test) under semi-static conditions. Fish were exposed for 96 h to mean measured Biofert Plusz concentrations ranging from 222 to 3861 mg fresh weight/L corresponding to 62.3 -1085 mg dry matter/L. Analytical monitoring of test material concentration was performed by HPLC and quantification of the main component (L-Threonine). The 96 h LC50 was determined to be 738 mg dry matter/L (effective).

Long-term toxicity to fish

Experimental results are not available.

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic fish toxicity tests shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC orDirective 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment of Biofert Plusz reveals neither a need to classifythe substance as dangerous for the environment, nor is it aPBTor vPvB substance, nor are there any further indications that the substance may be hazardous to aquatic organisms. According to reliable study results, Biofert Plusz is considered to be rapidly degraded in the environment and the bioaccumulation potential is regarded to be insignificant. Moreover, the amino acid threonine as the main constituent, is an essential protein constituent in living organisms and so no metabolites are expected to occur that pose a significant risk to living organisms. Therefore, with respect to animal welfare, the performance of a chronic fish study is assumed to be scientifically not justifiable.

Short-term toxicity to aquatic invertebrates

The acute toxicity of Biofert Plusz towards Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). 20 daphnids (5 daphnids/replicate) were exposed to Biofert Plusz for 48 h at nominal concentrations ranging from 469 to 3559 mg/L corresponding 132 -1000 mg dry matter/L to under semi-static conditions. The test material concentration was determined by HPLC based on L-Threonine (main component) measurements. The 48 h EC50 was determined to be 677 mg dry matter/L (nominal). Moreover, a 48 h NOEC=444 mg dry matter/L and a LOEC=667 mg dry matter/L were found.

Long-term toxicity to aquatic invertebrates

Experimental results are not available.

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic toxicity tests with invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on invertebrates. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC orDirective 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment of Biofert Plusz reveals neither a need to classify the substance as dangerous for the environment, nor is it aPBTor vPvB substance, nor are there any further indications that the substance may be hazardous to aquatic organisms. According to reliable study results, Biofert Plusz is considered to be rapidly degraded in the environment and the bioaccumulation potential is regarded to be insignificant. Moreover, the amino acid threonine as the main constituent, is an essential protein constituent in living organisms and so no metabolites are expected to occur that pose a significant risk to living organisms. Therefore, with respect to animal welfare, the performance of a long-term toxicity study with invertebrates is assumed to be scientifically not justifiable.

Toxicity to algae and cyanobacteria

The toxicity of Biofert Plusz towards the unicellular green alga Desmodesmus subspicatus was investigated in a study conducted according to OECD Guideline 201 (Alga, Growth Inhibition Test). Cultures of Desmodesmus subspicatus were exposed to 5 Biofert Plusz concentrations ranging from 339 to 3559 mg/L test material (nominal) corresponding to geometric mean measured concentrations ranging from 126 to 1579 mg/L test material. The concentration of the main component of Biofert Plusz L-Threonine was determined by HPLC/UV. Based on geometric mean measured concentrations the 72 h ErC50 and 72 h EyC50 were determined to be 528 and 254 mg fresh material/L, respectively, corresponding to 148 (ErC50) and 71.4 mg dry matter/L (EyC50).

Toxicity to microorganisms

The respiration inhibition of Biofert Plusz was investigated in a study conducted according to OECD Guideline 209. Non-adapted activated sludge was exposed to a Biofert Plusz concentration of 3560 mg/L nominal for 3 h under static conditions. Biofert Plusz was found to be not toxic to activated sludge at the concentration tested (3 h IC0=3560 mg/L nominal; corresponding to 1000 mg test material dry matter/L).