Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment from available information
Adequacy of study:
key study
Study period:
June-July 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific method and is described in sufficient detail.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: Final report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline required

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fluidized Bed Combustion (FBC) Fly Ash, Fluidized Bed Combustion (FBC) Bottom Ash

Results and discussion

Any other information on results incl. tables

PARTIAL CONCLUSION

Fluidized Bed Combustion (FBC) Fly Ash

The systemic effect (disappeared shortly after administration) was described after single oral administration of the substance Fluidized Bed Combustion (FBC) Fly Ash to rats. It is not possible to confirm absorption of the test substance from digestive tract. The clinical symptoms could related with total reaction of organism to application of the test substance.   

In inhalation study the systemic effects were observed and animals recovered slowly. It is not possible to confirm absorption of the test substance from respiration system, observed symptoms can bear on local effects in respiratory system.

After skin single application systemic toxic effects were not detected – the test substance does not penetrate through the skin. Although the substance contains Calcium oxide it is not irritant for skin. But certain irritant potential was found out after application on ears of mice. The test substance is not sensitizer.

After single application to conjunctival sac of eye systemic toxic effects were not detected – the test substance does not penetrate to body after eye exposure. The substance when applied to the eye evoked local reversible effect (due to Calcium oxide) – it is irritant for eye.

Based on results of 90-day study and reproduction toxicity screening study it could be deduced that the test substance is absorbed from gastrointestinal tract and it is distributed throughout the body of experimental animals to relatively distant compartments (e.g. effect on blood haematological and biochemical parameters, urine parameters and on liver, on reproductive system - testes and epididymis, ovaries and changes of sperms, influence on intrauterine development of offspring). According to toxicokinetic data from databases the Calcium oxide and other minerals and metals are absorbed in small intestine.

Information about excretion of (FBC) Fly Ash was not found out.

 

Fluidized Bed Combustion (FBC) Bottom Ash 

The systemic effect (disappeared shortly after administration) was described after single oral administration of the substance Fluidized Bed Combustion (FBC) Bottom Ash to rats. It is not possible to confirm absorption of the test substance from digestive tract. The clinical symptoms could related with total reaction of organism to application of the test substance.   

In Inhalation study the systemic effects were observed. It is not possible to confirm absorption of the test substance from respiration system. The symptoms can bear on local effects in respiratory system.

After skin single application systemic toxic effects were not detected – the test substance does not penetrate through the skin. Although the substance contains relatively high quantity of Calcium oxide it is not irritant for skin. But certain irritant potential was found out after application on ears of mice. The test substance is not sensitizer.

After single application to conjunctival sac of eye systemic toxic effects were not detected – the test substance does not penetrate through the eye. The substance when applied to the eye evoked local reversible effect (due to Calcium oxide) – it is irritant for eye.

Results of 90-day study showed that the test substance is absorbed from the digestive tract and enters the various compartments of body (e.g. changes of haematological parameters, changes of urine property, influence on liver). According to the results of Reproduction Screening it is not possible to determine if the substance does not penetrate into the organism at all or if it is absorbed without detrimental effect on reproductive system of treated males and females.

Information about excretion of (FBC) Fly Ash was not found out.

Applicant's summary and conclusion

Conclusions:
Absorption of (FBC) Ashes from the digestive system and their distribution throughout the body of experimental animals to relatively distant compartments was confirmed during oral repeated dose studies. Minerals and metals of (FBC) Ashes are absorbed largely in small intestine. No digestive tract irritation was noted.
Absorption to blood circulation after inhalation was not confirmed. The symptoms occured after respiratory exposure to (FBC) Ashes showed evidence rather of local effects and it is not possible to confirm absorption of the test substance from respiration system.
Skin and mucosa penetration: according to the studies of skin irritation/corrossion and sensitization the (FBC) Ashes do not penetrate through the skin and they are not skin irritants nor sensitizers. The (FBC) Ashes have certain irritant potential (due to the content of Calcium oxide). After single application to conjunctival sac of eye systemic toxic effects were not detected in Ashes – the substances do not penetrate through the eye. Irritant effect observed in both (FBC) Ashes was caused by Calcium oxide and intensity of irritation depended on concentration of Calcium oxide and on size of particles.
According to the experimental data negative influence on reproductive system of rat was described only in (FBC) Fly Ash. No literature data about abbility of Calcium oxide to affect reproduction was found out.
No information was found about the bioaccumulation and excretion of (FBC) Ashes.