Registration Dossier
Registration Dossier
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EC number: 603-436-5 | CAS number: 13076-17-0
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Transformation products:
- not measured
- Temp.:
- 21 °C
- Hydrolysis rate constant:
- ca. 0.23 h-1
- DT50:
- ca. 3 h
- Type:
- (pseudo-)first order (= half-life)
- Validity criteria fulfilled:
- no
- Conclusions:
- At 21 °C a hydrolysis half-life of 3 h (k = 0.23 h^-1) was determined 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.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.- 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
Referenceopen allclose all
Description of key information
According to Annex VIII, point 9.2.2.1, 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. D-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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
