Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only limited data has been provided by ECHA and it is difficult to make a full toxicokinetic assessment.

Data source

Materials and methods

Test guideline
Guideline:
other: Assessment

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Executive summary:

This is an extract from a toxicokinetics assessment report

Summary

Due to the absence of reported effects when tested, it is difficult to make conclusions concerning the adsorption, distribution or metabolism of the substance. Treatment related effects were observed in the 28 oral toxicity study suggesting that some adsorption takes place following oral exposure and that distribution, metabolism and excretion is likely due to the changes in blood and urine chemistry parameters based on data provided by ECHA. 

           

Absorption

There was no evidence of systemic toxicity reported in the data provided on the acute oral or dermal toxicity studies.  It is clear that there were no serious adverse effects at 5000 mg/kg as a single oral dose. 

System effects observed in the 28 day oral toxicity study would suggest that absorption does take place orally.  The absence of hydrolysis in the dark would suggest that the initial exposure in the GI tract is to the parent substance and not hydrolysis products.

The slight effect noted in one animal during a maximised application of a 30% blend of the substance may indicate that dermal penetration is only possible on punctured skin.  However, the level of detail and the effect being on only one animal makes this inconclusive.

Distribution

System effects were observed in the 28 day oral toxicity study with liver and kidney effects.  It is therefore possible to conclude that the substance, or the metabolites, are transported.  Despite the low water solubility, the substance is considered to have a relatively low adsorption coefficient and a partition coefficient Log 3.  Accumulation in fat or in other tissues is unlikely.

Metabolism

Despite relative stability in water and the absence of any biodegradation during testing, changes in blood chemistry imply that adaptive changes are taking place to metabolise the substance. 

There is no other evidence of metabolism mechanisms.

Excretion

Urine effects were noted in the 28 day oral toxicity study and although this may be a direct effect of the parent substance, it is possible that this is part of an adaptive change resulting from excretion of the substance or its metabolites. 

Conclusion

The absence of raw data from testing performed to meet base-set requirements means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion.  However, there is sufficient evidence that some oral absorption takes place and there is likely to be adaptive changes to the animals following transportation and possible metabolism.