Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 210-514-9 | CAS number: 617-48-1
Basic toxicokinetics
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:
- 1 999
- 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
- 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+
Constituent 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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