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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-045-4 | CAS number: 2338-05-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Remarks:
- Assumed since testing was done for medical reasons and recently carried out.
Test material
- Reference substance name:
- Iron citrate
- EC Number:
- 219-045-4
- EC Name:
- Iron citrate
- Cas Number:
- 2338-05-8
- Molecular formula:
- C6H8O7.xFe
- IUPAC Name:
- iron citrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Test article-related effects included a decrease in body weight and increased food intake, changes in serum iron parameters consistent with increased iron absorption, increased liver weight with signs of alteration of the liver function evidenced by an increase in liver enzyme and decreased albumin levels. These changes were associated with chronic inflammation foci and bile duct hyperplasia. Discoloration occurred in mediastinal and mesenteric lymph nodes together with accumulation of brown pigment in macrophages, sinus ectasia/cysts in rats.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 2 800 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- other: macrophages
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
The NOAEL was determined to be 2800 mg/kg in rats when ferric citrate was orally administered for up to 32 weeks
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was determined to be 2800 mg/kg in rats when ferric citrate was orally administered for up to 32 weeks
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
