Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information is derived by applying the Lipinski "rule of five", an accepted model of bioavailability.
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
The substance is expected to have very poor absorption in humans via oral, dermal and inhalation route due to the physico-chemical properties (i.e., high molecular weight, logPow > 6, insoluble in water, D50: 255.545 µm), thus it can be expected that the substance has very low bioavailability. The substance has low accumulation potential in human body.
Executive summary:

Absorption on the inhalation route

The chemical does not enter into human body via inhalation due to its high boiling point (> 375 ºC), very low vapour pressure (< 1.33 x 10-8Pa at 20 ºC) and large particle size (D50: 255.545 µm).

As over 10% of the powder particles have a particle diameter <100 µm there is a potential for dust particles to reach the thoracic and alveolar region of humans. The majority of them will be trapped in the nasal cavity and trachea and transported by ciliary cells of the respiratory epithelium to the oesophagus.

 

Absorption on the dermal or oral route

Bioavailability criteria have been developed by Lipinski et al (2001). The testing of the substasnce by using the “rule of five” model indicates that the substance is not bioavailable because the log Pow is >5.0 and the molecular mass is >500 Dalton.

 

A theoretical intake pathway of the substance could be via endocytosis, however, the quantity is expected to be insignificant.