Sodium feredetate

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

Molecular formula:

C10H12N2O8FeNa

IUPAC Name:

iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

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:

study cannot be used for classification

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.