Registration Dossier

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Weight of evidence
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Weight of evidence
Title:
Toxicokinetics
Author:
Sustainability Support Services (Europe) AB
Year:
2012
Bibliographic source:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: estimation
Vehicle:
unchanged (no vehicle)

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The absorption capacity of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is low (as has been stated section 5.4.1 of the dossier), which is also supported by the fact that the bioaccumulation factor for the substance is much lower and so even after the exposure the absorption capability will be less in this case.
Details on distribution in tissues:
In case the substance,3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, is absorbed (though in small quantity) it will not be accumulated in the body. This is supported by the fact that the substance have not only low BCF value (as mentioned in section 5.3.1 of the same dossier) but also have a moderate level of Kow which will support the reasoning that though the substance will enter the body but will get distributed through the lipid in the body.
Details on excretion:
Further to this distribution after the absorption process, the excretion process through urine would be faster as the molecular weight of the substance, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, is > 300 and this is a favourable value for excretion via the urine route.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: non bioaccumulation potential based on estiamtion results
Executive summary:

The substance, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, do not have a bioaccumulation potential based on estiamtion results supported by the facts of physicochemical parameters and persistant nature of the substance.