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EC number: 233-899-5 | CAS number: 10421-48-4
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:
- 2 002
- 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
- Reference substance name:
- 7782-63-0
- EC Number:
- 616-510-7
- Cas Number:
- 7782-63-0
- IUPAC Name:
- 7782-63-0
- 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
Constituent 1
Constituent 2
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.
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