Registration Dossier
Registration Dossier
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EC number: 203-615-4 | CAS number: 108-78-1
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Report of a screening study with children. Medical/epidemiological investigation not meeting standards as in guideline studies. The reliability can not be assigned.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
- Type of study / information:
- The report was to estimate the dietary exposure of melamine in infants and young children during the melamine crisis on the basis of the melamine content in the formula and the hypothetical infant formula consumption data.
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An estimation of the melamine exposure of infants was based on the recommended use and the analytical content of a diet.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
- Details on test material:
- Adulterated Sanlu infant formula.The most contaminated Sanlu infant formula samples were collected from the markets in Beijing and Gansu province (one of the heavily affected areas).
Constituent 1
Method
- Ethical approval:
- not applicable
- Details on study design:
- Four age groups of infants and young children (3, 6, 12, and 24 months) were chosen as the assessed subjects and the maximum amount of infant formula consumption was estimated based on the recommended usage level in the package insert of Sanlu infant formula and other brands.
Melamine was analyzed in 111 Sanlu infant formula samples collected from the markets in Beijing and Gansu province using the LC-MS-MS with a limit of quantification of 0.05 mg/kg. Four levels of melamine concentration were chosen to estimate the dietary intakes, including the mean, median, 90th percentile, and maximum. - Exposure assessment:
- estimated
Results and discussion
- Results:
- The infants of 3 months had the highest intake of melamine, and with the increase of the age (month), the intake decreased. Based on the median melamine concentration (1 000 mg/kg) as an example, the melamine intakes for the infants of 3, 6, 12, and 24 months were 23.4, 21.4, 15.0, and 8.6 mg/kg bw/d, respectively.
Any other information on results incl. tables
Dietary melamine intakes from tainted Sanlu infant formula significantly exceeded the TDI level (0.2 mg/kg bw/d) recommended by the WHO Expert Meeting in 2008. However, the present assessment has some limitations including the poor representative samples, the varied melamine concentrations in the adulterated Sanlu infant formula, and other brand infant formula possibly consumed by these infants.
Applicant's summary and conclusion
- Executive summary:
Objective: To estimate the dietary melamine exposure in Chinese infants and young children from the consumption of melamine adulterated Sanlu infant formula.
Methods:
Four age groups of infants and young children (3, 6, 12, and 24 months) were chosen as the assessed subjects and the maximum amount of infant formula consumption was estimated based on the recommended usage level in the package insert of Sanlu infant formula and other brands. Melamine was analyzed in 111 Sanlu infant formula samples collected from the markets in Beijing and Gansu province using the LC-MS-MS with a limit of quantification of 0.05 mg/kg. Four levels of melamine concentration were chosen to estimate the dietary intakes, including the mean, median, 90th percentile, and maximum.
Results:
The infants of 3 months had the highest intake of melamine, and with the increase of the age, the intake decreased. Based on the median melamine concentration (1 000 mg/kg) as an example, the melamine intakes for the infants of 3, 6, 12, and 24 months were 23.4, 21.4, 15.0, and 8.6 mg/kg bw/d, respectively.
Conclusion:
Dietary melamine intakes from tainted Sanlu infant formula significantly exceeded the TDI level (0.2 mg/kg bw/d) recommended by the WHO Expert Meeting in 2008. However, the present assessment has some limitations including the poor representative samples, the varied melamine concentrations in the adulterated Sanlu infant formula, and other brand infant formula possibly consumed by these infants.
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