Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published evaluation by the Joint FAO/WHO Expert Committee on Food Additives.

Data source

Reference
Reference Type:
other: Scientific Evaluation
Title:
Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives
Author:
Joint FAO/WHO Expert Committee on Food Additives
Year:
1999
Bibliographic source:
www.inchem.org

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
No data. The summary provides an overview of results without method details
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Fumaric acid
EC Number:
203-743-0
EC Name:
Fumaric acid
Cas Number:
110-17-8
IUPAC Name:
but-2-enedioic acid
Details on test material:
- Name of test material (as cited in study report): fumaric cid
- Molecular formula (if other than submission substance): C4H4O4
- Smiles notation (if other than submission substance): C(=C/C(=O)O)\C(=O)O
- InChl (if other than submission substance): 1/C4H4O4/c5-3(6)1-2-4(7)8/h1-2H,(H,5,6)(H,7,8)/b2-1+
Radiolabelling:
not specified

Test animals

Species:
other: No details available
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further information

Administration / exposure

Route of administration:
other: No further information
Vehicle:
not specified
Details on exposure:
No further information
Duration and frequency of treatment / exposure:
No further information
Doses / concentrations
Remarks:
Doses / Concentrations:
No further information
No. of animals per sex per dose / concentration:
No further information
Positive control reference chemical:
No further information
Details on study design:
No further information
Details on dosing and sampling:
No further information
Statistics:
No further information

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results Fumaric acid is an endogeneous material subject to biological control. As an integral part of aerobic respiration and metabolic cycles.
Fumaric acid is an organic dicarboxylic acid (C4H4O4). Fumaric acid occurs naturally in the metabolism. It plays a role in the tricarboxylic cycle (TCA
cycle) and in the carry over of the amino-N from aspartate.
Executive summary:

An acceptable daily intake (ADI) for fumaric acid has not been specified by the Joint FAO/WHO Expert Committee on Food Additives and fumaric acid is not considered to present a safety concern when ingested daily over a lifetime.