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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
basic toxicokinetics, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
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). Lactide hydrolysis in 0.1N HCI. Solutions of approximately 1250 ppm L-lactide in 0.1 N HC1 at 37 °C were prepared by adding 100 µL L-lactide solution (0.25 g/ml) in tetrahydrofuran (THF) to 20 mL of 0.1N HCI, heated to 37 °C, in 25-mL volumetric flasks. The flasks were stoppered and aged at 37 °C. Flasks were removed at various times, immediately cooled to room temperature in a cold water-bath, diluted to volume (1000 ppm theoretical), mixed thoroughly, and analysed directly by GC.
GLP compliance:
not specified
Type:
metabolism
Toxicokinetic parameters:
half-life 1st: 3 hr in aqueous medium at room temperature.
Toxicokinetic parameters:
half-life 1st: 0.4 hr in a 0.1 N HCI solution at 37 °C
Conclusions:
Lactide has a half-life of 3.0 h in an aqueous medium at room temperature. In addition, any lactide remaining unhydrolysed at the time of ingestion will be subject to rapid hydrolysis in the stomach. Lactide has a half-life of 0.4 hr in a 0.1 N HCI solution at 37 °C.
Executive summary:

In a toxicokinetic study, 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). Lactide has a half-life of 3.0 h in an aqueous medium at room temperature. In addition, any lactide remaining unhydrolysed at the time of ingestion will be subject to rapid hydrolysis in the stomach. Lactide has a half-life of 0.4 hr in a 0.1 N HCI solution at 37 °C.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione
EC Number:
603-436-5
Cas Number:
13076-17-0
Molecular formula:
C6H8O4
IUPAC Name:
(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione

Results and discussion

Main ADME results
Type:
metabolism

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Toxicokinetic parameters:
half-life 1st: 3 hr in aqueous medium at room temperature.
Toxicokinetic parameters:
half-life 1st: 0.4 hr in a 0.1 N HCI solution at 37 °C

Applicant's summary and conclusion

Conclusions:
Lactide has a half-life of 3.0 h in an aqueous medium at room temperature. In addition, any lactide remaining unhydrolysed at the time of ingestion will be subject to rapid hydrolysis in the stomach. Lactide has a half-life of 0.4 hr in a 0.1 N HCI solution at 37 °C.
Executive summary:

In a toxicokinetic study, 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). Lactide has a half-life of 3.0 h in an aqueous medium at room temperature. In addition, any lactide remaining unhydrolysed at the time of ingestion will be subject to rapid hydrolysis in the stomach. Lactide has a half-life of 0.4 hr in a 0.1 N HCI solution at 37 °C.

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