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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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
Type of information:
experimental study
Adequacy of study:
supporting study
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Peer-reviewed publication, but very poorly documented (complete lack of documentation of experimental conditions like pH, buffer systems, sterility, etc.), therefore considered as invalid.
no guideline followed
Principles of method if other than guideline:
Hydrolysis of L-lactide. A 100 or 1000 ppm solution of L-lactide was prepared by diluting a 1 % solution of lactide in acetonitrile with distilled water or 8 % ethanol at the appropriate temperature. Samples were aged at the respective temperatures, removed at various times and analysed directly by gas chromatography (GC).
GLP compliance:
Specific details on test material used for the study:
- Name of test material (as cited in study report): L-lactide
- Substance type: Organic
Analytical monitoring:
Details on sampling:
Directly analysed by GC.
30 min
80 °C
Initial conc. measured:
ca. 100 other: ppm
90 min
60 °C
Initial conc. measured:
ca. 100 other: ppm
180 min
21 °C
Initial conc. measured:
ca. 100 other: ppm
Transformation products:
not measured
21 °C
Hydrolysis rate constant:
ca. 0.23 h-1
ca. 3 h
(pseudo-)first order (= half-life)
Validity criteria fulfilled:
At 21 °C a hydrolysis half-life of 3 h (k = 0.23 h^-1) was determinded for L-lactide. The expermiments are, however, very poorly documented, not allowing an assessment of reliability. The study is considered to be invalid.
Executive summary:

Hydrolyis experiments with L-lactide are reported in a published paper, but methods and results are very poorly documented. Analytical methods, employed pH, buffers (if relevant), sterility of equipment, initial and measured concentrations, or any other crucial conditions, were not reported. The study is thus considered to be unreliable.

The half-life of L-lactide in water at 21 °C was determined to be 3 h, corresponding to a rate constant of 0.23 h–1.

Description of key information

According to Annex VIII, point, column 2 of the REACH Regulation, a hydrolysis study does not need to be conducted if the substance is readily biodegradable or highly insoluble in water. LL-lactide is predicted to be readily biodegradable hence a hydrolysis study is not considered to be required.

Key value for chemical safety assessment

Additional information