Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-09-13 to 1993-10-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Black red, fine grained and free-flowing solid

Details on test material:

- Test Article: CGA 65047 SG 100, (1-5787 A); identical to FeNaEDDHA
- Additional specification: Sequestrene 138 Fe 100 SG
- Physical state: granules; miscible in water
- Analytical purity: 100% (UVCB)
- Storage condition of test material: room temperature.

Test animals

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Aimal Production, 4332 Stein/ Switzerland
- Age at study initiation: Young adult
- Weight at study initiation: 184 to 226 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: The animal were housed in Macrolon cages type 4, with standardized soft wood bedding; the animals, segregated by sex, were group-housed (5 animals per cage)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau /SG, Switzerland, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degree C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing
- Mortality: daily; a.m. and p.m on working days, a.m. on weekend days
- Signs and symptoms: daily for 14 days
- immediately before administration and on days 7 and 14

- Necropsy of survivors performed: yes

Statistics:

Not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured in this study.

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in all animals. The animals recovered within 5 to 6 days.

Gross pathology:

At necropsy no deviations from normal morphology were found in all animals.

Other findings:

No other findings were noted

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median LD50 of the test substance FeNaEDDHA in albino rats was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of FeNaEDDHA in albino rats was determined acoording to the OECD Guideline 401 (Acute Oral Toxicity) and the EU Method B.1 (Acute Toxicity Oral). Upon an acute oral administration and a 14 day post-treatment observation period, the LD50 of the test material in albino rats was found to be greater than 2000 mg/kg bw. No mortalities occurred in this study. At necropsy no deviations from normal morphology were found in all animals. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in all animals. The animals recovered within 5 to 6 days.