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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, meets general scientific standards. Experiments were performed on LL-lactide. However, abiotic hydrolysis is independent from stereochemistry hence the results are likewise applicable to DD-lactide.

Data source

Reference
Reference Type:
publication
Title:
Safety assessment of polylactide (PLA) for use as a food-contact polymer
Author:
Conn RE, Kolstad JJ, Borzelleca JF, Dixler DS, Filer LJ Jr, LaDu BN Jr, Pariza MW
Year:
1995
Bibliographic source:
Food Chem Toxicol. 33(4): 273-283

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Hydrolysis of 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). 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 100µl L-lactide solution (0.25 g/ml) in tetrahydrofuran (THF) to 20 ml of 0.1 n 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 (1000ppm theoretical), mixed thoroughly, and analysed directly by GC.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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.