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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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium feredetate
EC Number:
239-802-2
EC Name:
Sodium feredetate
Cas Number:
15708-41-5
Molecular formula:
C10H12N2O8FeNa
IUPAC Name:
Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation
Constituent 2
Reference substance name:
FeNaEDTA
IUPAC Name:
FeNaEDTA
Details on test material:
Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%

Test animals

Species:
rat
Strain:
other: CD/Crl: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chalrles River, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 177-183 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-5%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 To:26th July 2007

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.8% aqueous hydroxypropylmethylcellulose
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage):10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
no
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortalities.
Mortality:
no mortalities
Clinical signs:
other: no clinical signs
Gross pathology:
No pathologicla changes observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
LD50 exceeding the limit dose of 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study according to OECD guideline 423 a group of female CD rats received a limit dose of 2000 mg/kd bw of FeNaEDTA by gavage administration. No adverse effects were noted, no clinical signs, no mortalities, no effect on body weight and no adverse findings at final necropsy after a 14 days observation period. The LD50 (oral,rat) exceeded 2000 mg/kg bw.