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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is readily biodegradable
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 9.2.2.1 the study does not need to be conducted if the substance is readily biodegradable. The substance rapidly degrades biotically. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, July 2017 and Chapter R.7b: Endpoint Specific Guidance, R.7.9, June 2017) the study does not need to be conducted.
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information

Description of key information

Hydrolysis: stable at acidic and neutral pH ranges (pH 5 to 7), unstable at pH 8.5 ca. 50% degradation at day 5 and ca. 100% degradation day 15, eq. or similar to OECD TG 111 – Tier 1, non-GLP, 2012

 

Note: substance is ‘readily biodegradable’ at pH 7.4 ± 0.2, and 22 ± 1°C, OECD 301F, GLP, 2011

Key value for chemical safety assessment

Additional information

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 9.2.2.1 the study does not need to be conducted if the substance is readily biodegradable. The substance rapidly degrades biotically. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, July 2017 and Chapter R.7b: Endpoint Specific Guidance, R.7.9, June 2017) the study does not need to be conducted.

 

Supporting information on hydrolysis:

Eq. or similar to OECD 111 – Tier 1, non-GLP, 2012: The hydrolytic stability of the test item was investigated using a method similar or equivalent to OECD TG 111 (hydrolysis as a function of pH) and EU Method A.7. The test media are standard aqueous buffers at pH 2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of non-ionic surfactant (Arkopal N 150). The tests are done in accelerated conditions at 40°C for approximately one month (28d). 200 – 300 ppm of test substance are dissolved in the pH buffer containing the surfactant and put into storage in an oven at 40°C. Commercial reference grades of buffer are utilised as listed in documented literature sources. Small aliquots of the test solution are extracted with an organic solvent (typically cyclohexane or ethyl acetate) containing a hydrocarbon standard (typically C12, C17 or C20) on a regular basis throughout the test (typically at time = 0, 0.25, 1, 2, 4, 7, 15, 21 and 28 days). The extracts are analysed by GC-FID. Under the analytical conditions employed constituent 1 was eluted and the results were then plotted with time to show the degradation curves of the substance. For constituent 1 of the test item at pH 2, 5 and 7, <10% degradation after 5 days was observed. Similarly, after 28 days at pH 2 and pH 5, <10% degradation was observed. At pH 7 and 28 days, about 30% degradation of the parent substance was observed at 40°C. It can be concluded that under the conditions of the study at pH 2 to 7, the substance is hydrolytically stable. At higher pH, the degradation of the substance is greater. At very basic pH (pH 12), the substance degrades completely within 5 hours. At pH of 8.5, after about 2 days there is 50% degradation, and at day 15, the substance is completely degraded. The t1/2 appears to be 48 hours. It can be concluded that under the conditions of the present test the test item is hydrolytically stable as defined in the OECD TG 111 for hydrolysis as a function of pH at acidic and neutral pH ranges. At basic pH ranges the test item is hydrolytically unstable.

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