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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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 250, 500 and 1000 mg/kg bw .
Body weight:
Compared to control, a significantly reduced body weight determined in the female animals exposed to 1000 mg/kg bw at 14 days after treatment.
However, no body weight effects observed at 14 days after the treatment in both sexes exposed to 2000 mg/kg bw. The reduced body weight in these groups was only examined at 1 day after treatment.
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.