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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Biodegradation: The substance was determined to be readily biodegradable (OECD Guideline No. 301B)

Adsorption/desorption: The adsorption coefficient of the test item was determined to be > 4.27 x 10E05 with Log10 Koc > 5.63 (OECD 121 and EU Method C.19)

Additional information

Abiotic degradation; Hydrolysis

Assessment of hydrolytic stability was not carried out using Method C.7 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 due to the test item having overall low solubility in aqueous media and being a complex mixture. It was considered that the test item would not readily hydrolyse at environmentally relevant temperature and pH.

 

The water solubility of the test item, in which all components were dissolved, would be significantly too low to perform the test as a sensitive enough analytical method would not be available. Additionally, the test solution would need to be half this concentration to satisfy the test requirements.

 

The test item is a complex mixture which the test method is not ideally suited. This is because components that are unstable could have significantly different hydrolytic rates and if there are components that are stable as well this would lead to conflicting results. Also, hydrolysis products of complex mixtures can be the same as some of the already present components and differentiating these would not be possible.

 

From information provided by the Sponsor, the main functional groups within the components of the test item were amides, amines esters and alcohols. Amines and alcohols would be expected to be stable to hydrolysis at environmentally relevant temperature and pH. Amides can hydrolyse, although with limited solubility in water the amide components of the test item may be essentially stable. Esters can hydrolyse at environmentally relevant temperature and pH, especially in basic conditions; but again, with limited aqueous solubility this may not be significant. As an overall consideration, the test item would not be expected to readily hydrolyse under environmentally relevant conditions.

 

Biodegradation

A key study was performed to assess the ready biodegradability of the test item 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 22 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 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 71% biodegradation after 28 days and satisfied the 10-Day window validation criterion, whereby 60% biodegradation must be attained within 10 days of the biodegradation exceeding 10%. The test item can therefore be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.

 

Adsorption / desorption coefficient (Koc)

The determination was 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 test utilised a High Performance Liquid Chromatograph. A commercially available cyanopropyl reverse phase HPLC column containing lipophilic and polar moieties was used. The adsorption coefficient of the test item was determined to be > 4.27 x 10E05 with Log10 Koc > 5.63.