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): Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide
- 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: solid

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 individual components. The estimation of toxicokinetic behaviour was performed only on the basis of the perfotmed tests.

Applicant's summary and conclusion

Executive summary:
Evaluation of toxicokinetics of the substance - Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide - was performed. It is required by the point 8.8.1 of Annex VII to the Directive (EC) No. 1907/2006.

Because the test substance is characterized as UVCB substance and its composition is very complicated, the literature search in toxicological databases was performed at first.

No toxicokinetic data about the test substance were not found out.

Estimation of toxicokinetic behaviour of the substance was performed mainly according to experimental data from the experimental results obtained by the toxicological testing.

 

Conclusions

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

The test substance was not absorbed from digestive tract after single administration of the test substance. No clinical symptoms were found out. The test substance did not penetrated through the skin of rabbit after single dermal application on the skin of rat. No clinical signs of intoxication were observed.

After single application of test substance to the skin of rabbits, systemic toxic effects were not detected – the substance obviously does not penetrate through the skin after acute exposure. No irritation potential was found out after application on ears of mice. The substance did not cause increase in radioisotope incorporation into the DNA of dividing lymphocytes.

After single application of the substance to conjunctival sac of the rabbit eye the local reversible effects (redness, chemosis and lacrimation) appeared. These changes had mild character. The substance was not irritating to the eye. Systemic toxic effects were not detected - the test substance does not penetrate to the body after acute eye exposure.

Results of Reproduction/Developmental study in rats revealed that the test substance had negative influence on reproduction parameters of parental females - decreased number of corpora lutea, implantations with effect on litter data - decreased number of pups and weight of litters was recorded. There was no evidence that the substance could get through placenta and affect the embryo or fetus. Development of pups was unaffected.

No information was found about absorption and excretion of the substance.