Registration Dossier
Registration Dossier
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EC number: 200-291-6 | CAS number: 56-84-8
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: opinion of authorities
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Opinion of FAO/WHO and US FDA.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 005
- Reference Type:
- other: law
- Title:
- Food additives permitted for direct addition to food for human consumption
- Author:
- FDA
- Year:
- 2 012
- Bibliographic source:
- 21CFR172.320. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=172.320
- Report date:
- 2012
Materials and methods
- Principles of method if other than guideline:
- Opinion of authorities.
Test material
- Reference substance name:
- Aspartic acid
- EC Number:
- 200-291-6
- EC Name:
- Aspartic acid
- Cas Number:
- 56-84-8
- Molecular formula:
- C4H7NO4
- IUPAC Name:
- aspartic acid
Constituent 1
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
L-aspartic acid (and L-aspartate) is regarded as “inherently safe” by the FDA. L-aspartic acid is added to the diet by the food industry.
According to the WHO Technical Report Series 928, Evaluation of certain food additives, Sixty-third report of the Joint FAO/WHO Expert Committee on Food Additives, WHO 2005 "The Committee was of the opinion that the use of the Procedure for the Safety Evaluation of Flavouring Agents (...) was inappropriate for 12 members of this group, namely, the eleven L-form alpha-amino acids (...; L-glutamic acid, No. 1420; ...; L-aspartic acid, No. 1429; ...) and the one alpha-imino acid (L-proline, No. 1425). These substances are macronutrients and normal components of protein and, as such, human exposure through food is orders of magnitude higher than the anticipated level of exposure from use as flavouring agents."
It is therefore highly unlikely that L-aspartic acid is a developmental toxic substance.
Applicant's summary and conclusion
- Conclusions:
- It is highly unlikely that L-aspartic acid is a developmental toxic substance.
- Executive summary:
L-aspartic acid (and L-aspartate) is regarded as “inherently safe” by the FDA. L-aspartic acid is added to the diet by the food industry.
According to the WHO Technical Report Series 928, Evaluation of certain food additives, Sixty-third report of the Joint FAO/WHO Expert Committee on Food Additives, WHO 2005 "The Committee was of the opinion that the use of the Procedure for the Safety Evaluation of Flavouring Agents (...) was inappropriate for 12 members of this group, namely, the eleven L-form alpha-amino acids (...; L-glutamic acid, No. 1420; ...; L-aspartic acid, No. 1429; ...) and the one alpha-imino acid (L-proline, No. 1425). These substances are macronutrients and normal components of protein and, as such, human exposure through food is orders of magnitude higher than the anticipated level of exposure from use as flavouring agents."
It is therefore highly unlikely that L-aspartic acid is a developmental toxic substance.
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