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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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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:
2005
Reference Type:
other: law
Title:
Food additives permitted for direct addition to food for human consumption
Author:
FDA
Year:
2012
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

Constituent 1
Chemical structure
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

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.