Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment from available information
Adequacy of study:
key study
Study period:
January 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific method and is described in sufficient detail.

Data source

Reference
Reference Type:
other: Final report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Guideline:
other: no guideline required

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

TOXICOKINETICS EVALUATION

ACCORDING TO THE EXPERIMENTAL DATA

The test substance, Ashes (residues) – Biomass Combustion, was applied to laboratory animals (mouse, rat, rabbit) during studies with different way of entry into organism (e.g. skin, stomach, eye).

Acute toxicity studies

Nontoxic for rats after single administration into the stomach. 

Ashes (residues) – Biomass Combustion administered at the dose level of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were observed in all six animals.

Nontoxic for rats after single dermal administration. 

Ashes (residues) – Biomass Combustion administered at the dose level of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were observed in all males and females.

No corrosive effects were observed on the skin of rabbit.

Very slight irritation (erythema) that disappeared quickly were observed on the skin of rabbit.

No clinical signs of systemic intoxication were observed.

No corrosive effects were observed on the eye of rabbit.

Irritation were observed on the eye of rabbit.

No clinical signs of systemic intoxication were observed.

The test substance is not a contact allergen in mouse.

The test substance, Ashes (residues) – Biomass Combustion, did not show a tendency to increase lymph node cell count, lymph node weight and ear weight in mice after application on skin of ears (it confirmed existing dermal irritation data).

Conclussion: The test substance, Ashes (residues) – Biomass Combustion – CAS No.: 68131 – 74 – 8, was applied to laboratory animals (mouse, rat, rabbit) during acute studies with different way of entry into organism (oral – by stomach, dermal, skin and eye).

The test substance applied to the stomach of the rat elicited no systemic effects. The substance applied on the skin of mouse elicited no effects at the site of application and no systemic toxic effects. The substance applied on the skin of rabbit elicited effects at the site of application that disappeared quickly without systemic toxic effects. The substance when applied to the mucous membrane (conjunctivae) of the rabbit elicited slight effects at the site of application (disappeared until the 7th day) without systemic toxic effects.

Long-term toxicity study

The negative effect on some haematological parameters, some biochemical parameters, biometry of organs and urine properties were observed after 90-day administration into the stomach of rat.

Body weight, food consumption, food conversion, water consumption, mortality, health condition, behaviour and macroscopical structure of organs of rats were unaffected by treatment of the test substance.

The negative effect of the test substance (haematological parameters – red component – changes of value of haemoglobin, white component – changes of differential leucocyte count, protrombin time and fibrinogen; biochemical parameters – changes of sodium, chloride and calcium ions, value of cholesterol, urea, bilirubin, phosphorus, creatinine and concentrations of total protein; biometry of organs – changes of value of weights of adrenal glands, liver, spleen, kidneys heart, testes, epididymides) were expressed especially at the highest dose level – 1000 mg/kg/day.

Most of changes which were found out at the middle and at the lowest dose level - 160 and 400 mg/kg/day (haematological parameters – changes of value of haemoglobin, fibrinogen, APTT; biochemical parameters – changes of value of chloride ions, urea) had only mild intensity and they did not give evidence of adverse reaction of animal organism.          

Body weight, food consumption, food conversion, water consumption, mortality, health condition, behaviour and macroscopical structure of organs of rats were unaffected by treatment of the test substance.

Conclussion: The results of the 90-day subacute toxicity study with oral administration to the rats showed the negative effect on some biochemical and haematological parameters of the blood. So the Ashes (residues) – Biomass Combustion – CAS No.: 68131 – 74 – 8 enters the blood circulation of rats and has negative effect on concentration creatinine and concentration sodium ions (hyponatraemia) - when it is applied orally. 

ACCORDING TO THE RESULTS OF LITERARY DATA

No relevant toxicokinetic references.

ACCORDING TO THE DATABASES DATA

No relevant toxicokinetic references.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: See conclusions
The systemic effects were not described after single oral administration of Ashes (residues) – Biomass Combustion – CAS No.: 68131 – 74 – 8, to rats. The test substance is nontoxic after single administration into the stomach.
After skin or eye single application systemic toxic effects were not detected – the test substance is probably not absorbed through the skin or eye.
Effect on haematological and biochemical blood parameters in 90-day study confirmed that the test substance is absorbed from digestive tract and enters the blood circulation.
No information about the distribution and elimination of the substance is available.