Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: data review and expert estimation
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The toxicokinetic assessment is prepared by evaluating the available physical properties and toxicological properties.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Preliminary studies:
Estimated oral adsorption factor 10%
Estimated inhalatory adsorption factor 50%
Estimated dermal adsorption factor 10%
Low bioaccumulation potential

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No experimental data available.

Any other information on results incl. tables

Estimated oral adsorption factor 10%

Estimated respiratory adsorption factor 50%

Estimated dermal adsorption factor 10%

Low bioaccumulation potential

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Executive summary:

Oral adsorption

The hydrophilic character of Everzol Orange ED-G Crude (logPow <= -4.0) will limit this passive diffusion and although the water solubility is high, >= 368 g/L, the large molecular weight (816.77 g/mol) will prevent passage through the aqueous pores. Furthermore, ionization of Everzol Orange ED-G Crude will impair the uptake since compounds need to pass the lipid membranes in the gastrointestinal wall, Martinez 2002. It is therefore unlikely that Everzol Orange ED-G Crude will be absorbed to a high extent from the gastro-intestinal tract. For risk assessment purposes the oral absorption of Everzol Orange ED-G Crude is set at 10%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.

 

Respiratory adsorption

There are no data available providing direct information on respiratory absorption. The low vapour pressure (<8.40 x 10-7 Pa) indicates that Everzol orange ED-G crude is not available for inhalation as a vapour. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 μm may reach the thoracic region and those below 15 μm the alveolar region of the respiratory tract. The particle size distribution for Everzol orange ED-G crude indicates, that the particles of Everzol orange ED-G crude have the potential to be inhaled, with particles present with a size <50 µm and <15 µm. Based on the particle size distribution, particles can reach both the thoracic region as well as the alveolar region. Based on the high water solubility, Everzol orange ED-G crude has the potential to diffuse readily into the mucus lining of the respiratory tract. Log Kow, molecular weight and ionization lower the potential for absorption. For risk assessment purposes inhalatory absorption is expected to be less than the standard 100% and is set at 50%.

 

Dermal adsorption

A solid has to dissolve into the surface moisture of the skin before uptake can begin. Although the water solubility for Everzol Orange ED-G Crude is high (>= 368 g/L), the hydrophilic property (log Pow <= - 4.0) of Everzol Orange ED-G Crude is not favourable for penetration into the stratum corneum. According to the criteria given in the REACH guidance R.7c, 10% dermal absorption will be considered in case MW > 500 and log Kow <-1 and >4, otherwise 100% dermal absorption should be used, Martinez 2002. As Everzol Orange ED-G Crude meets these criteria for restricted dermal absorption, 10% dermal absorption is used for risk assessment purposes.

Base on the physic-chemical properties of Everzol Orange ED-G crude, the potential for bioaccumulation is considered to be low.