Iron trinitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was well documented and meets generally accepted scientific principles, and conducted in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

7782-63-0

EC Number:

616-510-7

Cas Number:

7782-63-0

IUPAC Name:

7782-63-0

Constituent 2

Reference substance name:

iron sulphate heptahydrate

IUPAC Name:

iron sulphate heptahydrate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Sulfuric acid, iron(2+) salt (1:1), heptahydrate
- Molecular formula (if other than submission substance): FeSO4.7H2O
- Molecular weight (if other than submission substance): 278.01
- Physical state: powder, blue-green crystals
- Storage condition of test material: room temperature under argon

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan Charles River Co. Ltd., Hino Animal Center, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: males: 99 - 113 g and females: 90 - 101 g
- Fasting period before study: 18 hours
- Housing: stainless steel cages, 755x210x170 mm
- Diet (ad libitum): pellets, CRF-1 (Oriental Yeast Co., Ltd.)
- Water (ad libitum): tap water
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 40-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2001-05-16 To: 2001-06-07

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0, 25, 50, 100, 200 mg/mL. The concentrations of test item in the vehicle were verified using a titration method. The measured concentrations were 96.4 - 104.2% of the nominal concentrations.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

250, 500, 1000 and 2000 mg/kg bw/day

No. of animals per sex per dose:

Five

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily for observations and weighing on days 1, 3, 7, 10 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (general observations), body weight and food consumption

Statistics:

Body weight and food consumption were calculated as Mean ± SD. Bartlett and Dunnett test were conducted.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: 5 males exposed to 2000 mg/kg bw showed salivation and reduced activity 4 and 6 hours after treatment. 4 females showed reduced activity 6 hour after treatment. Effects were reversible after 24 hours. No abnormalities were observed in groups treated with

Gross pathology:

No toxicologically relevant effects observed.

Other findings:

no information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for iron sulphate heptahydrate was greater than 2000 mg/kg bw/d.

Executive summary:

In an acute oral toxicity study, conducted in accordance with the extant OECD 401 guideline , and in accordance with principles of GLP, the LD50 for iron sulphate heptahydrate was greater than 2000 mg/kg bw/d. By read-across, based on similar toxicity profiles for iron salts, the test material iron triitrate is also considered not to be classified for acute oral toxicity.