Registration Dossier
Registration Dossier
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EC number: 253-575-7 | CAS number: 37640-57-6
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non standard investigation
Data source
Reference
- Reference Type:
- publication
- Title:
- Determination of melamine and cyanuric acid in human urine by a liquid chromatography tandem mass spectrometry
- Author:
- Zhang et al
- Year:
- 2 010
- Bibliographic source:
- Journal of Chromatography B, 878, 758–762
Materials and methods
- Endpoint addressed:
- not applicable
- Principles of method if other than guideline:
- analytical method development and base urine concentrations in China
- GLP compliance:
- no
Test material
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: approved by the Hospital Ethical Committee
- Details on study design:
- The newly developed analytical methods were successfully applied to the analysis of urine samples collected from 86 infants and
110 adults.
Results and discussion
Any other information on results incl. tables
Table: Number of cases and ratio in concentration range of melamine and cyanuric acid in baby and adult urine.
| Conc. range (ng/ml) | <10 | 10–100 | 100–1000 | 1000–10,000 | >10,000 | |
| Melamine | Baby | 15 (17.4%) | 40 (46.5%) | 15 (17.4%) | 14 (16.3%) | 2 (2.3%) |
| Adult | 14 (12.7%) | 76 (69.1%) | 15 (13.6%) | 5 (4.5%) | 0 (0%) | |
| Cyanuric acid | Baby | 2 (2.3%) | 48 (55.8%) | 34 (39.5%) | 1 (1.2%) | 1 (1.2%) |
| Adult | 1 (0.9%) | 85 (72.3%) | 22 (20.0%) | 2 (1.8%) | 0 (0%) |
Applicant's summary and conclusion
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