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Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: review analysis by a peer reviewed database
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conclusions were established on basis of data from publications and observations in man analysed by a peer reviewed database.

Data source

Reference
Reference Type:
other: peer reviewed database
Title:
International program on Chemical Safety
Author:
IPCS Inchem
Year:
2010
Bibliographic source:
http://www.inchem.org/documents/jecfa/jecmono/v17je02.htm search with CAS number 506-87-6 in 2010/10/08

Materials and methods

Endpoint addressed:
repeated dose toxicity: oral
Principles of method if other than guideline:
no data

Results and discussion

Results:
Ammonium ions are normal metabolites in man. Although specific toxicological data for ammonium carbonate are limited, extrapolation of results from studies with ammonium compounds (primarily ammonium chloride) and with sodium or potassium carbonate provide a basis for evaluation. Clinical studies in man show that administration of high doses of ammonium chloride or of sodium bicarbonate results in changes in the acid-base balance. This is the normal physiological response.
The levels of ammonium carbonate in the diet from food additive use are extremely small compared to the levels required to cause physiological changes and pose no toxicological hazard.
On the basis of the available data (toxicological, biochemical, and other), the total daily intake of the substance, arising from its use or uses at the levels necessary to achieve the desired effect and from its acceptable background in food, does not, in the opinion of the Committee, represent a hazard to health. For this reason, and for the reasons stated in individual evaluations, the establishment of an acceptable daily intake (ADI) in mg/kg bw is not deemed necessary.

Applicant's summary and conclusion

Conclusions:
On the basis of the available data (toxicological, biochemical, and other), the total daily intake of the substance, arising from its use or uses at the levels necessary to achieve the desired effect and from its acceptable background in food, does not, in the opinion of the Committee, represent a hazard to health. For this reason, and for the reasons stated in individual evaluations, the establishment of an acceptable daily intake (ADI) in mg/kg bw is not deemed necessary.