long chain alkyl thio carbamide metal complex

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is highly insoluble in water

Executive summary:

Testing was not carried out according to Method C7 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 for the following reasons:

 

·                    The test material was experimentally determined to have a very low water solubility value of <1.00 x 10^-6g/l (1 µg/L or 1 ppb) The guideline states in (b)(5) Applicability and Specificity “For chemicals whose solubility is below 1 ppb, the water solubility should be characterized as ‘less than 1 ppb’ with no further quantification.”

 

·                    The hydrolysis guidelines require an initial solution concentration of less than one-half the water solubility for materials determined to have a water solubility of less than 2 x 10^-2M. This requirement conflicts with the above outlined reporting limit imposed by the water solubility guideline that was applicable to this test substance. Additionally, the guidelines also require use of an analytical method capable of determining solution concentrations of the test material at 10% of the initial test concentration, further increasing the sensitivity that an analytical method would require. For this material, test material concentrations, even after extracting and concentrating the samples, would likely to be less than the limit of quantification.

Description of key information

The hydrolysis test was not carried out according to OECD Test guideline 111.

The guideline requires an analytical method capable of determining solution concentrations of the test material.

The water solubility study demonstrated to have a low water solubility as it was determined to be less than the practical quantitation limit of the analytical method employed and is therefore reported at less than 0.31 mg/L. Therefore, it is unlikely that an analytical method can be developed to analyse the test material. This substance therefore meets the adaption criteria according to REACH Regulation (EC) No 1907/2006 section 9.2.2.1, column 2.