Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2018
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

Constituent 1
Chemical structure
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
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.