Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Reliable toxicity studies for fish, invertebrates and algae have been conducted for the substance and are included in this dossier.  These key studies are summarised below.  Reliable modelled data are available for the test substance for long-term chronic toxicity to the three trophic levels of aquatic organism. No study data are available for microorganisms, however a reliable (Klimisch 2) toxicity study for the analogue substance methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate is available for this endpoint.

 

A reliable (Klimisch 1) short-term toxicity study with fish has been conducted on the test substance (CAS 94313-91-4) and is included in this dossier. Elementis Specialities (2009) reports an LC50 for short term toxicity in fish of >251.3 mg test material/L (101 mg/L active substance/L). This value will be taken as the short-term toxicity in fish endpoint for the test substance. No reliable long-term toxicity data are available for the toxicity of the test substance to fish. However, modelled data using the QSAR model, Ecological Structure Activity Relationships (ECOSAR) Class Program to estimate long-term toxicity to fish was used to derive chronic toxicity values. The ECOSAR model estimates aquatic toxicity based on the structural similarity to chemicals for which aquatic studies are available. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 0.5 mg/L for amides and fish appear to be the most sensitive organisms from the three trophic levels modelled. This value is taken for the long-term toxicity to fish endpoint.

 

A reliable (Klimisch 1) short-term toxicity study with invertebrates has been conducted on the test substance and is included in this dossier. El;ementis Specialities (2009) reports an EC50 for short term toxicity in Daphnia magna of 136 mg test item/L (54.4 mg active substance/L). Consequently this value will be taken as the short-term toxicity in invertebrates endpoint for the substance. No reliable long-term toxicity data are available for the toxicity of the test substance to invertebrates. However, modelled data using the QSAR model, Ecological Structure Activity Relationships (ECOSAR) Class Program to estimate long-term toxicity to invertebrates are available. The ECOSAR model estimates aquatic toxicity based on the structural similarity to chemicals for which aquatic studies are available. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 29 mg/L for amides. This value is taken for the long-term toxicity to invertebrates endpoint.

 

A reliable (Klimisch 2) toxicity study with algae has been conducted on the test substance and is included in this dossier. Elementis Specialities (2010) reports a 72-hr LC50 for toxicity in Pseudokirchneriella subcapitata of 0.097 mg/L and a 72-hr NOEC of 0.016 mg/L, based on growth. Consequently these values will be taken as the toxicity in algae endpoint for the substance. Modelled data using the QSAR model, Ecological Structure Activity Relationships (ECOSAR) Class Program to estimate long-term toxicity to green algae are also available. The ECOSAR model estimates aquatic toxicity based on the structural similarity to chemicals for which aquatic studies are available. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 8 mg/L for amides. The measured laboratory toxicity test value of 0.016 mg/l is taken for the long-term toxicity to algae endpoint.

 

A reliable toxicity study with microorganisms is not available on the test substance. However, a reliable (Klimisch 1) toxicity study with microorganisms has been conducted on the analogue substance methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate and is included in this dossier. Elementis Specialities (2012) reports a 3-hr EC50 for toxicity to microorganisms of 80 mg/L and a 3-hr NOEC of 32 mg/L. Consequently these values will be taken as the toxicity in microorganisms endpoint for the test substance (CAS 94313-91-4).

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