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EC number: 946-072-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The animal experiments were designed to compare the toxicologic and hematinic properties of ferrous fumarate with those of ferrous sulphate A.R.,ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of ferrous gluconate is 11.7 per cent. Sixty-four adult rabbits having free access to food and water were dosed orally with tablets. The dose was 450 mg Fe/Kg for each ferrous salt, the rabbits receiving twelve tablets of gluconate per Kg. The gluconate tablets contained 36 mg. The gluconate tablets were broken to facilitate administration; the other tablets were administered whole.
The tablets were administered at 10 p.m. and the mortalities were recorded at 10 a.m. next morning. The surviving rabbits were then killed, and the stomachs and livers from all the animals were examined macroscopically and those from three of each group histologically. The macroscopic changes in the gastric mucosa were classified according to the scheme in Table 1, which includes the mortality figures. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- The substances compared in these tests were ferrous fumarate, ferrous sulphate A.R., ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 per cent, respectively.
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Sixty-four adult rabbits having free access to food and water
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 450 mg Fe/kg (= 12 tablets of ferrous gluconate each containing 36 mg iron)
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 12 hours
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no data
- Other examinations performed: percentage mortalities was recorded, no further details available - Sex:
- not specified
- Dose descriptor:
- other: concentration inducing the effects specified under 'Remarks'
- Effect level:
- 450 mg/kg bw
- Based on:
- element
- Remarks on result:
- other:
- Remarks:
- The stomach of one revealed iron incrustation of the mucosa, while that of another showed superficial mucosal necrosis and iron in the vessels. In both, the pylorus showed early inflammation. Iron impregnation was apparent in the lamina propria of one, and there was iron in the vessels of the other. The livers showed a “chemical hepatitis,” the essential features of which were iron impregnation of parenchymal cells, their invasion and replacement by polymorphs, and an increase in intravascular polymorphs.
- Mortality:
- 3/9
- Clinical signs:
- 4/9 animals showed inflamation of the gastric mucosa (12 hours after giving a single dose equivalent to 450 mg Fe/kg). One of them slight and 3 of them severe and extensive inflammation
- Body weight:
- not examined
- Gross pathology:
- Gluconate: The stomach of one revealed iron incrustation of the mucosa, while that of another showed superficial mucosal necrosis and iron in the vessels. In both, the pylorus showed early inflammation. Iron impregnation was apparent in the lamina propria of one, and there was iron in the vessels of the other. The livers showed a “chemical hepatitis,” the essential features of which were iron impregnation of parenchymal cells, their invasion and replacement by polymorphs, and an increase in intravascular polymorphs.
- Executive summary:
The animal experiments were designed to compare the toxicologic and hematinic properties of ferrous fumarate with those of ferrous sulphate A.R.,ferrous succinate and ferrous gluconate B.P.C (Berenbaum, 1960). The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 %, respectively. 64 adult rabbits having free access to food and water were dosed orally with tablets of ferrous fumarate, ferrous sulphate compound, ferrous succinate or ferrous gluconate. The dose was 450 mg Fe/Kg, the rabbits receiving seven tablets of fumarate or sulphate compound, or twelve tablets of succinate or gluconate per Kg. The fumarate and sulphate tablets contained 65 mg Fe, the succinate and gluconate tablets 36 mg. The gluconate tablets were broken to facilitate administration; the other tablets were administered whole.
The tablets were administered at 10 p.m. and the mortalities were recorded at 10 a.m. next morning. The surviving rabbits were then killed, and the stomachs and livers from all the animals were examined macroscopically and those from three of each group histologically. The macroscopic changes in the gastric mucosa were classified according to the scheme in Table 1, which includes the mortality figures. The macroscopic changes in the gastric mucosa were classified according to the scheme in table 1, which includes the mortality figures.
The histologic findings were as follows:
Gluconate.-The stomach of one revealed iron incrustation of the mucosa, while that of another showed superficial mucosal necrosis and iron in the vessels. In both, the pylorus showed early inflammation. Iron impregnation was apparent in the lamina propria of one, and there was iron in the vessels of the other. The livers showed a “chemical hepatitis,” the essential features of which were iron impregnation of parenchymal cells, their invasion and replacement by polymorphs, and an increase in intravascular polymorphs.
In a second experiment, four groups of three adult rabbits were dosed orally with tablets of the four iron compounds. As before, the dose employed was 450 mg Fe/Kg. On this occasion none of the animals died within 12 hours of being dosed. They were all killed at this stage, and their stomachs were removed, washed with saline, and photographed.
The macroscopic changes in the gastric mucosa were classified according to the scheme in table 1, which includes the mortality figures.
The histologic findings were as follows:
Gluconate.-The stomach of one revealed iron incrustation of the mucosa, while that of another showed superficial mucosal necrosis and iron in the vessels. In both, the pylorus
showed early inflammation. Iron impregnation was apparent in the lamina propria of one, and there was iron in the vessels of the other. The livers showed a “chemical hepatitis,” the essential features of which were iron impregnation of parenchymal cells, their invasion and replacement by polymorphs, and an increase in intravascular polymorphs.
In a second experiment, four groups of three adult rabbits were dosed orally with tablets of the four iron compounds. As before, the dose employed was 450 mg Fe/Kg.
On this occasion none of the animals died within 12 hours of being dosed. They were all killed at this stage, and their stomachs were removed, washed with saline, and photographed.
Table 1 -Effects of iron gluconate tablets on Rabbit Gastric Mucosa (12 hours after giving a single dose equivalent to 450 mg Fe/kg) |
|
Effects observed |
Ferrous gluconate |
None |
2/9 |
Slight inflammation |
1/9 |
Severe and extensive inflammation |
3/9 |
Death within 12 hours |
3/9 |
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The animal experiments were designed to compare the toxicologic and hematinic properties of ferrous fumarate with those of ferrous sulphate A.R.,ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 per cent, respectively. The sulphate was administered as an aqueous solution and the other three compounds as aqueous suspensions containing 0.1 per cent w/v of tragacanth.
The subchronic oral toxicities of the four ferrous salts were compared in albino rats of the WAG strain. Ferrous sulphate solution and suspensions of the fumarate, gluconate and succinate containing 20 mg Fe/ml were employed in this experiment. 45 male and 45 female rats (40 to 100 g bodyweight) were randomly distributed into nine groups of five males and five females. One group was not dosed and served as controls, while the other eight groups received oral doses of one or other of the iron compounds at a level of 50 or 100 mg Fe/Kg. The animals were individually weighed at intervals and dosed daily, excluding weekends. After 12 weeks’ dosing, the red and total white cell counts and hemoglobin concentrations were determined on two males and two females from each group. All the rats were then killed, and the major organs (liver, spleen, heart, lungs, thymus, kidneys, adrenals, thyroid, testes, prostate, seminal vesicles, ovaries and uterus) were excised, blotted dry, and weighed. The organs from two males and two females from each group dosed at 50 mg Fe/Kg were examined histologically. - GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- The substances compared in these tests were ferrous fumarate, ferrous sulphate A.R., ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 per cent, respectively.
- Species:
- rat
- Strain:
- other: albino rats of the WAG strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 40 to 100 g bodyweight
- Fasting period before study: not specified
- Housing: 5 per group
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
DETAILS OF FOOD AND WATER QUALITY: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To: - Route of administration:
- oral: unspecified
- Vehicle:
- other: suspensions of the gluconate containing 20 mg Fe/mL were employed in this experiment
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 other: mg Fe/kg
- Dose / conc.:
- 50 other: mg Fe/kg
- Remarks:
- corresponding to 427.35 mg ferrous gluconate/kg
- Dose / conc.:
- 100 other: mg Fe/kg
- Remarks:
- corresponding to 854.70 mg ferrous gluconate/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: not specified
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale (if not random): ramdom - Observations and examinations performed and frequency:
- observed for clinical signs daily, weighted in intervals, blood examinations (red and total white cell count and hemoglobin concentraitions on 2 males and 2 females from each group)
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
All the rats were then killed, and the major organs (liver, spleen, heart, lungs, thymus, kidneys, adrenals, thyroid, testes, prostate, seminal vesicles, ovaries and uterus) were excised, blotted dry, and weighed. The organs from two males and two females from each group dosed at 50 mg Fe/Kg were examined histologically. - Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Data showed that at the higher dose level ferrous gluconate significantly depressed growth rate in the male rats, but not in the females.
At the lower dose level the depressions produced in the males by the gluconate were not significant (P = 0.05). - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities were found in the red or total white cell counts or hemoglobin concentrations.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- None of the organ weights (expressed in mg/100 g bodyweight) in the dosed groups differed significantly (P = 0.05) from those of the controls
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Apart from a slight and variable increase in iron deposition in the tissue phagocytes (e.g., Kupffer cells, pulmonary macrophages and adrenal cortical littoral cells), histologic examination of the organs listed above revealed no abnormalities that could be attributed to the drugs.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
- Details on results:
- The group mean increases in bodyweight after 12 weeks are given in table 1. Analysis of the combined data showed that at the higher dose level all four compounds significantly depressed growth rate in the male rats, but not in the females. At the lower dose level the depressions produced in the males by the fumarate and the gluconate were not significant (P = 0.05). None of the organ weights (expressed in mg/100 g bodyweight) in the dosed groups differed significantly (P = 0.05) from those of the controls. Likewise no abnormalities were found in the red or total white cell counts or hemoglobin concentrations.
Apart from a slight and variable increase in iron deposition in the tissue phagocytes (e.g., Kupffer cells, pulmonary macrophages and adrenal cortical littoral cells), histologic examination of the organs listed above revealed no abnormalities that could be attributed to the drugs. - Dose descriptor:
- NOAEL
- Effect level:
- 427.35 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- histopathology: non-neoplastic
- Remarks on result:
- other: calculated based on the ferrous iron content of 11.7 % given for ferrous gluconate
- Dose descriptor:
- NOAEL
- Effect level:
- 50 other: mg Fe/kg
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- histopathology: non-neoplastic
- Critical effects observed:
- no
- Executive summary:
The animal experiments were designed to compare the toxicologic and hematinic properties of ferrous fumarate with those of ferrous sulphate A.R., ferrous succinate and ferrous gluconate B.P.C (Berenbaum, 1960). The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 per cent, respectively. The sulphate was administered as an aqueous solution and the other three compounds as aqueous suspensions containing 0.1 per cent w/v of tragacanth.
The subchronic oral toxicities of the four ferrous salts were compared in albino rats of the WAG strain. Ferrous sulphate solution and suspensions of the fumarate, gluconate and succinate containing 20 mg Fe/mL were employed in this experiment. 45 male and 45 female rats (40 to 100 g bodyweight) were randomly distributed into nine groups of five males and five females. One group was not dosed and served as controls, while the other eight groups received oral doses of one or other of the iron compounds at a level of 50 or 100 mg Fe/Kg. The animals were individually weighed at intervals and dosed daily, excluding weekends. After 12 weeks’ dosing, the red and total white cell counts and hemoglobin concentrations were determined on two males and two females from each group. All the rats were then killed, and the major organs (liver, spleen, heart, lungs, thymus, kidneys, adrenals, thyroid, testes, prostate, seminal vesicles, ovaries and uterus) were excised, blotted dry, and weighed. The organs from two males and two females from each group dosed at 50 mg Fe/Kg were examined histologically.
Analysis of the combined data showed that at the higher dose level all four compounds significantly depressed growth rate in the male rats, but not in the females. At the lower dose level the depressions produced in the males by the fumarate and the gluconate were not significant (P = 0.05). None of the organ weights (expressed in mg/100 g bodyweight) in the dosed groups differed significantly (P = 0.05) from those of the controls. Likewise no abnormalities were found in the red or total white cell counts or hemoglobin concentrations.
Apart from a slight and variable increase in iron deposition in the tissue phagocytes (e.g., Kupffer cells, pulmonary macrophages and adrenal cortical littoral cells), histologic examination of the organs listed above revealed no abnormalities that could be attributed to the drugs.
Taking into account all given data, a NOAEL of 50 mg Fe/kg bw, corresponding to a value of 427.35 mg Ferrous gluconate/kg bw can be established.
The group mean increases in bodyweight after 12 weeks are given in Table 1. Analysis of the combined data showed that at the higher dose level all four compounds significantly depressed growth rate in the male rats, but not in the females. At the lower dose level the depressions produced in the males by the fumarate and the gluconate were not significant (P = 0.05). None of the organ weights (expressed in mg/100 g bodyweight) in the dosed groups differed significantly (P = 0.05) from those of the controls. Likewise no abnormalities were found in the red or total white cell counts or hemoglobin concentrations.
Apart from a slight and variable increase in iron deposition in the tissue phagocytes (e.g., Kupfer cells, pulmonary macrophages and adrenal cortical littoral cells), histologic examination of the organs listed above revealed no abnormalities that could be attributed to the drugs.
Table 1 -The Effects of 4 Iron Compounds on Growth Rate in Rats |
|||||||||||||
Daily oral dose |
Group mean increases in body weight ± S.E. (Gm.) after 12 weeks' dosing |
||||||||||||
Controls |
Fumarate |
Sulphate |
Gluconate |
Succinate |
|||||||||
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
||||
0 |
181 ± 13.6 |
92 ± 6.6 |
|
|
|
|
|
|
|
|
|||
50 |
156 ± 11.7 |
101 ± 6.8 |
129 ± 10.7 |
73 ± 11.7 |
172 ± 10.2 |
106 ± 11.1 |
145 ± 6.8 |
95 ± 8.3 |
|||||
100 |
|
|
136 ± 12.8 |
87 ± 10.7 |
113 ± 10.8 |
84 ± 8.8 |
136 ± 13.3 |
85 ± 7.5 |
135 ± 11.1 |
96 ± 12.4 |
Data source
Reference
- Reference Type:
- publication
- Title:
- Animal and Human Studies on Ferrous Fumarate, an Oral Hematinic
- Author:
- Berenbaum, M.C., Child, K.J., Davis, B., Sharpe, H.M. and Tomich, E.G.
- Year:
- 1 960
- Bibliographic source:
- Blood 1960 15:540-550
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The animal experiments were designed to compare the toxicologic and hematinic properties of ferrous fumarate with those of ferrous sulphate A.R.,ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of ferrous gluconate was 11.7 per cent. The ferrous gluconate was administered as aqueous suspension containing 0.1 per cent w/v of tragacanth. Groups of 10 male fawn mice ( GFF strain, bodyweights 17 to 22 gr ) were dosed orally and then observed for seven days, when the percentage mortalities were recorded. The LD50 values, which were calculated according to do Beer (1945) and expressed in mg Fe/Kg.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Iron digluconate
- EC Number:
- 206-076-3
- EC Name:
- Iron digluconate
- Cas Number:
- 299-29-6
- Molecular formula:
- C12H22FeO14
- IUPAC Name:
- Iron; (2R,3R,4S,5S)-2,3,4,5,6-pentahydroxyhexanoic acid
- Details on test material:
- not available
Constituent 1
- Specific details on test material used for the study:
- The substances compared in these tests were ferrous fumarate, ferrous sulphate A.R., ferrous succinate and ferrous gluconate B.P.C. The ferrous iron contents of these four salts are 33.0, 20.0, 24.8 and 11.7 per cent, respectively.
Test animals
- Species:
- mouse
- Strain:
- other: GFF
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Groups of 10 male fawn mice (GFF strain, bodyweights 17 to 22 gr)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: aqueous suspensions containing 0.1 per cent w/v of tragacanth.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not stated
- Lot/batch no. (if required): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: not stated
DOSAGE PREPARATION (if unusual): aqueous suspensions containing 0.1 per cent w/v of tragacanth.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified - Doses:
- not specifed only LD50 values are given
- No. of animals per sex per dose:
- presumably 10 males
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no data
- Other examinations performed: percentage martalities was recorded, no further details available - Statistics:
- LD50 values were calculated according to do Beer (1945) and are expressed in mg Fe/Kg.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 320 mg/kg bw
- Based on:
- element
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 735 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculated according to the ferrous iron content (11.7%) given for ferrous gluconate
- Mortality:
- no details available, only LD50 value is given
- Clinical signs:
- no details available, only LD50 value is given
- Body weight:
- no details available, only LD50 value is given
- Gross pathology:
- no details available, only LD50 value is given
Any other information on results incl. tables
The LD50 value for ferrous gluconate was calculated taking into account the ferrous iron content given for this compound (11.7 %) and is 2735 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 value for ferrous gluconate was calculated taking into account the ferrous iron content given for this compound (11.7 %) and is 2735 mg/kg bw.
- Executive summary:
The substances compared in these acute oral toxicity tests in mice were ferrous fumarate, ferrous sulphate A.R., ferrous succinate and ferrous gluconate B.P.C (Berenbaum, 1960). The ferrous iron contents of ferrous gluconate was 11.7 per cent. It was administered as aqueous suspensions containing 0.1 per cent w/v of tragacanth.
Groups of 10 male fawn mice (GFF strain, bodyweights 17 to 22 gr) were dosed orally and then observed for seven days, when the percentage mortalities were recorded. The LD50 values, which were calculated according to do Beer (1945) and expressed in mg Fe/Kg, were fumarate 630, succinate 560, gluconate 320 and sulphate 230. Thus, the relative toxicities were fumarate 1 , succinate 1 .1 , gluconate 2.0 and sulphate 2.7.
The LD50 value for ferrous gluconate was calculated taking into account the ferrous iron content given for this compound (11.7 %) and is 2735 mg/kg bw.
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