Registration Dossier
Registration Dossier
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EC number: 603-436-5 | CAS number: 13076-17-0
Basic toxicokinetics
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
- 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
Constituent 1
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
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