Registration Dossier
Registration Dossier
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EC number: 202-739-6 | CAS number: 99-20-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- Feb. 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information (physicochemical properties)
- GLP compliance:
- no
Test material
- Reference substance name:
- Trehalose
- EC Number:
- 202-739-6
- EC Name:
- Trehalose
- Cas Number:
- 99-20-7
- Molecular formula:
- C12H22O11
- IUPAC Name:
- trehalose
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- no physical test performed
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- oral route identified as major route, dermal route as potential second route.
- Type:
- distribution
- Results:
- no specific distribution pattern identifiable
- Type:
- metabolism
- Results:
- specific enzyme (Trehalase) present, 100 % metabolism possible
- Type:
- excretion
- Results:
- excretion unlikely, to a small extent by urin
Any other information on results incl. tables
Absorption:
Based on above data the substance may be absorbed through the skin in relevant amounts (molecular weight < 500 g/Mol, -1 < log POW< 4, see EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRETORATE-GENERAL: Guidance Document on Dermal Absorpiton Sanco/222/2000 rev. 7 19 March 2004).
Although the calculated log POWis below the threshold for dermal absorption of log POW= -1, the experimental procedure does not allow determination in such range. Therefore absorption via skin cannot be excluded.
For exposure assessments a default value of 100 % of absorption after dermal exposure may be appropriate.
The uptake after direct inhalation of the substance may be of low relevance due to the high mean diameter of particles, which significantly exceeds the maximum inhalable particle diameter of 10 µm. Uptake by inhalation after evaporation is unlikely, the substance is a solid at room temperature has a very low vapour pressure. Additionally the substance decomposes upon heating.
For exposure assessments a default value of 10 % of absorption via inhalation may be appropriate.
The absorption after oral ingestion cannot be calculated due to lack of data; by default an absorption of 100 % may be appropriate, until specific data will be available. Observations in repeated dose toxicity studies show significant absortion by oral route.
Distribution:
The substance is hydrophilic and Protein binding should be quite low, resulting in a low distribution volume. Therefore distribution to specific organs should only depend on the blood flow rate of the organs with lung, kidney and liver as potentially primary targets. Crossing of membrane barriers like the Blood/Brain barrier seems unlikely. However, as the substance is made up of natural occurring sugars, certain receptors may exist, enhancing the membrane crossing ability.
Metabolism and Excretion:
The substance is a disaccharide which will be metabolized by the Enzyme Trehalase in the small intestines. The metabolic products are Glucose, which are further metabolized.
The substance will most likely be completely metabolized. Excretion is rather unlikely, to a small extent urinary excretion may be present.
Applicant's summary and conclusion
- Conclusions:
- The toxicokinetic behaviour of Trehalose was assessed based on physicochemical properties and known metabolism pathways.
The substance is of natural origin and specific enzymes for metabolism are present.
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