Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Biodegradation
Two biodegradation studies were conducted. The first test item containing mineral oil attained 25 % biodegradation after 28 days and the second test item without oil attained 33 % biodegradation after 35 days (OECD 301B and EU Method C.4-C). The substance is therefore considered not readily biodegradable (OECD 301 B, EU Method C4 -C and OCSPP 835.3110).
Additional information
Abiotic degradation; Hydrolysis
Testing was not carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The main reason for that decision was that the active ingredient in the test item is organic and the test method is not applicable to inorganic substances. In addition, the test item comprised a significant proportion of an insoluble oil, and the sample solution concentration in aqueous media in which all the test item was dissolved would be impractically low to perform the test.
Biodegradation
Key study 1
In the first key study, ready biodegradability of the test item was investigated in an aerobic aqueous medium. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No. 301B, "Ready Biodegradability; CO2 Evolution Test" referenced as Method C.4-C of Commission Regulation (EC) No. 440/2008 and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph (m)).
The test item, at a concentration of 10 mg carbon/L, was exposed to activated sewage sludge micro-organisms with mineral medium in sealed culture vessels in the dark at temperatures of between 21 and 24 °C for 28 days.
Following the recommendations of the International Standards Organisation (ISO 1995), the test item was dissolved in an auxiliary solvent prior to being adsorbed onto a filter paper and subsequent dispersal in test media. Using this method, the test item is evenly distributed throughout the test medium and the surface area of test item exposed to the test organisms is increased thereby increasing the potential for biodegradation.
The test item was a complex mixture containing 42.2% mineral oil. At the Sponsors request additional vessels were prepared containing mineral oil at the same concentration as in the test item preparations; 7.6 mg/L.
The biodegradation of the test item was assessed by the determination of carbon dioxide produced. Control solutions with inoculum and the reference item, sodium benzoate, together with a toxicity control were used for validation purposes.
The test item attained 25 % biodegradation after 28 days and results obtained from the mineral oil vessels showed 24 % biodegradation over the test period. The test item therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.
Key study 2
In the second key study, ready biodegradability of the test item was assessed in an aerobic aqueous medium. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No. 301B, "Ready Biodegradability; CO2 Evolution Test" referenced as Method C.4-C of Commission Regulation (EC) No. 440/2008 and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph (m)).
The test item, at a concentration of 20 mg carbon/L, was exposed to activated sewage sludge micro-organisms with mineral medium in sealed culture vessels in the dark at temperatures of between 20 and 25 °C for 35 days. The test was extended to 35 days at the request of the Sponsor.
The biodegradation of the test item was assessed by the determination of carbon dioxide produced. Control solutions with inoculum and the reference item, sodium benzoate, together with a toxicity control were used for validation purposes.
The test item attained 33 % biodegradation after 35 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.
Adsorption coefficient
Testing was not carried out using the HPLC screening method, designed to be compatible with Method C.19 Adsorption Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 121 of the OECD Guidelines for Testing of Chemicals, 22 January 2001. The reason for that decision was that the active ingredient in the test item is inorganic and the test guidelines state they are not applicable to inorganic substances.
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