Registration Dossier
Registration Dossier
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EC number: 942-732-1 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment was conducted based on an examination of the physical and chemical properties of the substance, its composition, and the toxicokinetics behaviour of its constituents.
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment was conducted based on an examination of the physical and chemical properties of the substance, its composition, and the toxicokinetics behaviour of its constituents.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- EC Number:
- 942-732-1
- Molecular formula:
- C13H19NO4S.C2H7NO/C2H7NO/H2O
- IUPAC Name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- Test material form:
- other: liquid
- Details on test material:
- Name of test material: Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)Physical state: pale yellow liquidSubstance type: multi-constituent substanceStorage conditions: Room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Products of hydrolysis and dissociation likely to be absorbed
- Type:
- distribution
- Results:
- Products of hydrolysis and dissociation likely to be transported
- Type:
- excretion
- Results:
- No evidence from testing on the excretion of the constituents and their metabolites
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study resultsThe 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 considered likely that if ingested, there will be some abiotic activity with dissociation and hydrolysis processes. The theoretical products of this activity, including 6[(p-tosyl)amino] hexanoic acid are likely to be absorbed and transported in the blood. There is no indication of accumulation and metabolic action is likely. It is not considered appropriate to perform further animal studies on this substance.
- Executive summary:
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion of the registered substance. However, an assessment of the toxicokinetics behaviour of the constituents of the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) - namely 6-[(p-tosyl)amino]hexanoic acid, 2-aminoethanol, and water - has been performed in conjunction with an assessment of the available toxicological data.
2-aminoethanol and its products are expected to be absorbed if ingested and readily metabolised with NH3 and acetyl-CoA as its final metabolites, but there is little evidence regarding the 6-[(p-tosyl)amino]hexanoic acid. It is considered that adsorption of the dissociation and acid-hydrolysis products of the 6-[(p-tosyl)amino]hexanoic acid will occur, and a non-quantitative assay performed on the substance did demonstrate a peak in blood concentrations at 3 hours, indicating that a significant amount of the acid is therefore absorbed; this is supported by unchanged substance being identified in urine after an oral ingestion. This presence in blood indicates that the substance is likely to be distributed in the body, but there is no effects reported that could highlight specific target organs. Metabolism of the 6-[(p-tosyl)amino]hexanoic acid is expected, as the cytotoxicity was reduced in presence of metabolic activation during the bacterial gene mutation assay. This metabolism and the peak in blood suggest that the substance will not accumulate. 6-[(p-tosyl)amino]hexanoic acid was identified in urine after an oral ingestion, but the amount of unchanged product and metabolites was not calculated.
It is therefore not considered appropriate to perform further animal studies on this substance.
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