Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment from available information
Adequacy of study:
key study
Study period:
August - September 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Assessment report meets generally accepted scientific method.

Data source

Reference
Reference Type:
other: Final assessment report
Title:
Unnamed
Year:
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): Tar, brown-coal, low-temp.
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Smiles notation: not known - UVCB substance
- InChl: not known - UVCB substance
- Substance type: technical product
- Physical state: viscous liquid

Results and discussion

Preliminary studies:
No experimental data about absorption, distribution or excretion were found in literature. Due the complex composition of the substance is very difficult to estimate the behaviour of each individual component in addition of others components. It is evident that the behaviour of individual components in organisms could be interacted each another.

Applicant's summary and conclusion

Executive summary:

Evaluation of toxicokinetics of the substance - Tar, brown-coal, low-temp. - was performed. It is required by the point 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006.

The test substance is characterized as UVCB substance and its composition is very complicated. No toxicokinetic data were found in the literature about the test substance. . Estimation of toxicokinetic behaviour of the substance was performed mainly according to experimental data from the results obtained by the toxicological testing. 

 

After single oral administration of the substanceTar, brown-coal, low-temp.,to rats, no clinical symptoms of systemic intoxication were found out. The results did not allow to make the decision about absorption of the substance from digestive tract. If it is absorbed, the absorption occurs in such a doses, which do not allow the detection of toxicity symptoms in this type of acute toxicity test.

After single dermal application of the test substance to the skin of rats, no clinical signs of intoxication were recorded.After application of the test substance on ears of mice in the LLN assay, it showed a tendency to cause the increase in ear weight.The results did not allow to make the decision about the absorption of the substance through the skin. If it is absorbed, it occurs in such a doses, which do not allow the detection of toxicity symptoms in this type of acute toxicity test. 

Aftersingle application of test substance to the skin of rabbits, systemic toxic effects were not detected – the conclusion is the same as stated above.

After single application of the substance to conjunctival sac of the rabbit eye,the highest degree of conjunctiva chemosis (value of 4) and conjunctiva redness (value of 3)appeared. Systemic toxic effects were not detected.The results did not allow to make the decision about the absorption of the substance through the skin. If it is absorbed, the absorption occurs in such a doses, which do not allow the detection of toxicity symptoms in this type of acute toxicity test.

When measuring the sensitization effect in the LLNA, the test substance Tar, brown-coal, low-temp caused a significant increase in radioisotope incorporation into the DNA of dividing lymphocytes in adjacent lymph node. This is the proof that the test substance penetrates at least through stratum corneum to epidermis. There is no indication that further penetration of the substance to the dermis and other tissues occurs, because no clinical signs of systemic intoxication were detected in this experiment. Similarly, theseresults did not allow to make the final decision about the absorption of the substance through the skin.

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