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: Assessment based on public literature

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Results and discussion

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
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.
Executive summary:

Absorption

There was evidence of effects in organs (kidney) following repeated oral exposure, suggesting absorption by this route. There was no evidence of absorption through the skin, although surface active substances will typically undergo some skin absorption. This class of substance is used widely in cosmetics and there no evidence was found relating to adverse effects from dermal exposure

 

Work on cosmetic ingredients suggests no more than 20% absorption from dermal exposure to humans.

 

Distribution

System effects were observed in the 28 day oral toxicity study with kidney effects. It is therefore possible to conclude that the substance, or the metabolites, are transported. With the high water solubility, the substance is considered to have a relatively low risk of accumulation in fat or in other tissues.

 

Metabolism

Despite relative stability in water, the high level of biodegradation during testing suggests that metabolism is likely. In the mutagenicity studies, there was marginally higher toxicity in the absence of S-9, but this is not a conclusive indicator that metabolic activity is taking place. 

 

There is no other evidence of metabolism mechanisms.

 

Excretion

Kidney 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.