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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Remarks:
Assessment report
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Assessment based on data generated for this registration

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment based on test data

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
EC Number:
260-976-0
EC Name:
Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
Cas Number:
57834-33-0
Molecular formula:
C17H18N2O2
IUPAC Name:
ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Eversorb EP4
- Substance type: Liquid
- Composition of test material, percentage of components: 98.94%
- Lot/batch No.: 4023
- Storage condition of test material: Ambient
Radiolabelling:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
No evidence
Type:
distribution
Results:
No evidence
Type:
metabolism
Results:
No evidence
Type:
excretion
Results:
No evidence

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The only evidence of possible absorption if ingested are the blood changes in the 28 day toxicity study, but this may in turn have been cause by stress in the animals (such as taste aversion). Unfortunately, the dose levels selected were too low to indicate any specific toxicity parameters.

Dermal penetration of liquids of this molecular weight may occur, but there is no evidence of skin penetration from dermal studies, including in-vivo non-LLNA sensitisation studies.
Details on distribution in tissues:
If absorbed, it is likely that there is distribution, although no target organ was identified. The effect in the spleen is generally considered secondary to other stress and may not be a direct toxic effect
Details on excretion:
Benzoates are not excreted, but are instead metabolised and metabolites will ultimately include carbon dioxide and water.

Aniline compounds are excreted in the urine and kidney effects are expected.

The test substance did not cause kidney effects at the doses used.

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
The available data from other tests do not provide sufficient information to make a full assessment.

Benzoates and anilines are readily metabolised and metabolic pathways have been described in public literature. The biodegradation test indicates that metabolic pathways exist in aerobic microbes.

Methyl aniline is metabolised in the liver and liver damage may occur.