Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

No determination was possible according toMethod C7 Abiotic Degradation, Hydrolysis as a Function of pH of CommissionRegulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 for the following reasons:

  • The test material has been determined to be essentially insoluble in water.
  • The test material is a mixture; the test is not appropriate for mixtures.

An assessment of hydrolytic stability was attempted using the computer-based estimation software, HYDROWIN, version 2.00, © 2000 US Environmental Protection Agency. However, the software could not estimate the rate constants for the test material.

Ready biodegradation studies have shown that the material does degrade by abiotic means i.e. hydrolysis, although the rate of hydrolysis is not provided by these studies.

The test item attained 20% degradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No 301B.

The substance has a log Pow value of 6.58.

In combination, the above factors would normally lead the substance to be classified as R53 May cause long-term adverse affects to the aquatic environmenment under the DSD. However, a Dapnhia reproduction study has demonstrated that there are no long-term adverse effects in the aquatic environment and therefore the substance should not be classified as such.

Reliability

The above studies have all been ranked reliability 1 according to the scoring system of Klimisch et al (except for the HYDROWIN prediction which is assigned a reliability of 2). This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.