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: The toxicokinetics assessment was produced based on observations of the substance during endpoint testing for toxicity endpoints duting 2013.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment was made based on the results of endpoint testing for REACH.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
There was no evidence of systemic effects reported in the data provided on the acute oral or dermal toxicity studies, but blood parameter changes observed in the repeat dose oral toxicity study would suggest that absorption does take place orally.
Details on distribution in tissues:
System effects were observed in the subacute oral toxicity study with changes in blood chemistry and minor findings in the liver and kidneys. It is therefore possible to conclude that the substance, or the metabolites, are transported.
Details on excretion:
There is no evidence from testing performed that there is subsequent excretion of the absorbed substance or any metabolites formed.

Metabolite characterisation studies

Details on metabolites:
The triethanolamine will readily metabolise, with the nitrogen and carbon being utilised. There is no evidence of metabolic activity in animals, but work on phenylsulphonamides suggests metabolic pathways will exist in cells.

Any other information on results incl. tables

The data provided suggested no significant clinical signs. No useful evidence relating to toxicity was obtained from the data provided for the acids.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The data provided suggested no significant clinical signs. No useful evidence relating to toxicity was obtained from the data provided for the acids.
Executive summary:

Toxicokinetic assessment

The data provided suggested no significant clinical signs. No useful evidence relating to toxicity was obtained from the data provided for the acids.

Absorption

There was no evidence of systemic effects reported in the data provided on the acute oral or dermal toxicity studies, but blood parameter changes observed in the repeat dose oral toxicity study would suggest that absorption does take place orally.

Distribution

System effects were observed in the subacute oral toxicity study with changes in blood chemistry and minor findings in the liver and kidneys. It is therefore possible to conclude that the substance, or the metabolites, are transported.

Metabolism

The triethanolamine will readily metabolise, with the nitrogen and carbon being utilised. There is no evidence of metabolic activity in animals, but work on phenylsulphonamides suggests metabolic pathways will exist in cells.

Excretion

There is no evidence from testing performed that there is subsequent excretion of the absorbed substance or any metabolites formed.

Conclusion

The absence of specific toxicokinetic data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion. It is not considered appropriate to perform further animal studies on this substance.