Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Evaluation and assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and log Pow
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: Expert statement
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
Assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and log Pow
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467

Radiolabelling:
no

Test animals

Species:
other: Not applicable
Strain:
other: Not applicable
Details on test animals or test system and environmental conditions:
Not applicable

Administration / exposure

Route of administration:
other: Not applicable
Vehicle:
other: Not applicable
Details on exposure:
Not applicable

Duration and frequency of treatment / exposure:
Not applicable

Doses / concentrations
Remarks:
Doses / Concentrations:
Not applicable

No. of animals per sex per dose / concentration:
Not applicable

Control animals:
other: Not applicable
Positive control reference chemical:
Not applicable

Details on study design:
Not applicable

Details on dosing and sampling:
Not applicable

Statistics:
Not applicable

Results and discussion

Preliminary studies:
None
Main ADME resultsopen allclose all
Type:
absorption
Results:
Dermal absorption is unlikely due to the negative log Pow and the acidic character of test substance. However, after oral gavage test substance is at least partially absorbed.
Type:
metabolism
Results:
Partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely.
Type:
other: accumulation
Results:
Accumulation of the test substance in the fatty tissues of the body is unlikely. Correspondingly, organ discolorations largely disappeared after the 14-wk recovery period.
Type:
excretion
Results:
via kidneys and additionally via feces is likely

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No data

Details on distribution in tissues:
No data

Details on excretion:
No data

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
Not applicable


Any other information on results incl. tables

Evaluation and Assessment:

 

Due to the negative log Pow and the acidic character of test substance a dermal absorption is unlikely. This is in accordance with the data obtained in the acute dermal toxicity and dermal irritation study.

An oral resorption of test substance is also restricted due to the low log Pow of -5.1 since most substances with a log Pow <0.5 are only marginally resorbed. However, after oral gavage test substance is at least partially absorbed.

 

As test substance is an azo dye, partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely

 

Due to the physico-chemical properties of the test substance a major accumulation of the chemical in the body is unlikely. Test substance is excreted via kidneys. An additional elimination via feces is likely, since the molecular weight of the substance is >300.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: does not show any toxicokinetic peculiarity
Based on the physico-chemical properties of test substance and the results obtained in various toxicological examinations, it can be concluded that the test substance does not show any toxicokinetic peculiarity
Executive summary:

Evaluation and assessment of the toxicokinetic properties of the test substance was carried out based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and logPow.

Based on the physico-chemical properties of test substance and the results obtained in various toxicological examinations, it can be concluded that the test substance does not show any toxicokinetic peculiarity.