Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Toxicity: oral

Currently viewing:

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2012
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed and reported GLP study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium [N-[2-[bis(carboxymethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(4-)]ferrate(1-)
EC Number:
EC Name:
Sodium [N-[2-[bis(carboxymethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(4-)]ferrate(1-)
Cas Number:
Molecular formula:
Not available
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
Description: red brown powder
Batch: CFC-10340 (308H0351)
Purity/Composition: ~81%
Test substance storage: at room temperature protected from light
Stability under storage conditions: stable
Expiry date: 1 December 2012
Test substance handling
- For moisture: no specific handling required
- For light: use amber-coloured glassware or wrap container in tin-foil
pH: 6-7 in water at concentration of 1%
Stability in vehicle: Water 1 year
Solubility in vehicle: Water, approximately 700 g/L

Test animals

Details on test animals or test system and environmental conditions:
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age and body weight: young adult animals (approx. 8 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: ear- and tailmark

Conditions: Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were recorded in the raw data and were considered to have had no effect on the outcome of the study.

Accommodation: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).

Water: Free access to tap water.

Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
Vehicle: water (Elix, Millipore S.A.S., Molsheim, France).
Rationale: the vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance data supplied by the sponsor.
Preparation: the formulations (w/w) were prepared within 4 hours prior to dosing. The (test substance) formulations were protected from light using amber coloured glassware. Homogeneity was accomplished to a visually acceptable level. No correction was made for purity of the test substance.

Method: oral gavage, using plastic feeding tubes.
Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
Frequency: single dosage on Day 1.
Dose level (volume): 2000 mg/kg (10 mL/kg) body weight.
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
Details on study design:
Mortality/Viability: twice daily.
Body weights: days 1 (pre-administration), 8 and 15.
Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy: at the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.

Not needed, limit test

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mL/kg bw
Based on:
test mat.
No mortality occurred.

Clinical signs:
other: Hunched posture and/or piloerection was noted among all animals on Day 1. In addition, diarrhoea was shown by three animals on Day 2.
Gross pathology:
Macroscopic examination did not reveal any toxicologically relevant abnormalities.
Diaphragmatic hernia of the liver noted in one animal was a background finding for rats of this age and strain.
Other findings:

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The oral LD50 value was in excess of 2000 mg/kg bw
Executive summary:

The study was carried out based on the guidelines described in: OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"; Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"; EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"; JMAFF guidelines (2011) including the most recent partial revisions.

HEDTA-Fe(III)Na was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred. Hunched posture and/or piloerection was noted among all animals on Day 1. In addition, diarrhoea was shown by three animals on Day 2. The body weight gain shown by the animals over the study period was considered to be normal. Macroscopic examination did not reveal any toxicologically relevant abnormalities. The oral LD50value of HEDTA-Fe(III)Na in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, HEDTA-Fe(III)Na does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) andRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.