Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Additional physico-chemical information
Administrative data
- Endpoint:
- other: determination of aromatic amines
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Determination of aromatic amines in the test substance: Determination of unsulfonated primary aromatic amines after acid extraction. For the quantification in the extract, an HPLC-method was used; for the qualitative detection of other amines, a colorimetric reaction was performed.
- GLP compliance:
- no
Test material
- Reference substance name:
- bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate
- Cas Number:
- 115811-45-5
- Molecular formula:
- C29H19N9O10S2.2C6H16NO3
- IUPAC Name:
- bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate
- Test material form:
- solid
1
Results and discussion
- Results:
- The analysis of the HPLC showed that in the extract no compounds with a retention time of the main primary aromatic amines were found, especially no compounds with the retention times of benzidine, o-dianisidine, o-tolidine and b-naphthylamine.
The colorimetric test showed a negative result as well. The sample solution showed an extinction below 0.04 absorption units.
Applicant's summary and conclusion
- Conclusions:
- No primary aromatic amines were detected in the substance.
- Executive summary:
Determination of aromatic amines in the substance was performed using a HPLC-method and a colorimetric reaction method.
The analysis of the HPLC showed that in the extract no compounds with a retention time of the main primary aromatic amines were found, especially no compounds with the retention times of benzidine, o-dianisidine, o-tolidine and b-naphthylamine. The colorimetric test showed a negative result as well. The sample solution showed an extinction below 0.04 absorption units.
Taken together, no primary aromatic amines could be detected in the substance.
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