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EC number: 205-447-7 | CAS number: 141-01-5
- 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
Endpoint summary
Administrative data
Description of key information
Repeated Dose toxicity- Oral
Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of the test chemical using rats. The study was performed on 5 male and 5 females rats per group at dose levels of 0, 50 or 100 mg/Kg for 12 weeks. The animals were observed for changes in body weight, hematology parameters, organ weight changes were noted and histological parameters were noted. An increase in group mean body weight was observed after 12 weeks. At higher dose levels (100 mg/Kg), depressed growth rate in the male rats was noted but the effect was not observed in female rats. At 50 mg/Kg, the depression in growth rate produced in the male rats was not significant. No abnormalities were found in the red and total white cell counts or hemoglobin concentration. None of the organ weights in the dosed group differed significantly (P: 0.05) from those of the controls. Histological examination of the organs did not reveal the abnormalities apart from slight and variable increase in the iron deposition in the tissue phagocytes. Based on the observation made, the No Observed Adverse Effect
Level (NOAEL) for the test chemical was considered to be 50 mg/Kg using albino rats of WAG strain.
Repeated dose toxicity -Inhalation
A short-term toxicity study doesnot need to be conducted because exposure of humans via inhalation in production/use is not likely based on the thorough and rigorous risk assessment provided. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver
Repeated dose toxicity -Dermal
A short-term toxicity study doesnot need to be conducted because exposure of humans via dermal route in production/use is not likely based on the thorough and rigorous risk assessment provided. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of the test chemical using rats
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Albino rats of WAG strain
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: 40 to 100 gm
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: unspecified
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- Daily excluding weekends
- Remarks:
- 0, 50 and 100 mg Fe/kg
- No. of animals per sex per dose:
- Total: 30
0 mg/Kg : 5 males and 5 females
50 mg/Kg: 5 males and 5 females
100 mg/Kg: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Details on study design
- Dose selection rationale: No data available
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available - Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included: No data available
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: At intervals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: After 12 weeks dosing
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: 2 males and 2 females from each group
- Parameters checked in table [No.?] were examined: Red and total white cell count and hemoglobin concentration
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined: No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined: No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: No data available
sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, the major organs ( liver, spleen, heart, lungs, thymus, kidneys, adrenals, thyroid, testes, prostate, seminal vesicles, ovaries and uterus ) were excised, blotted dry, and weighed.
HISTOPATHOLOGY: Yes, the organs from two males and two females from each group dosed at 50 mg Fe/kg were examined histologically. - Other examinations:
- No data
- Statistics:
- Standard deviation
- Clinical signs:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- An increase in group mean body weight was observed after 12 weeks. At higher dose levels (100 mg/Kg), depressed growth rate in the male rats was noted but the effect was not observed in female rats. At 50 mg/Kg, the depression in growth rate produced in the male rats was not significant.
- 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 specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities were found in the red and total white cell counts or hemoglobin concentration
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- 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 in the dosed group differed significantly (P: 0.05) from those of the controls.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histological examination of the organs did not reveal the abnormalities apart from slight and variable increase in the iron deposition in the tissue phagocytes.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound Ferrous fumarate is considered to be 50 mg/Kg using albino rats of WAG strain.
- Executive summary:
Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of the test chemical using rats. The study was performed on 5 male and 5 females rats per group at dose levels of 0, 50 or 100 mg/Kg for 12 weeks. The animals were observed for changes in body weight, hematology parameters, organ weight changes were noted and histological parameters were noted. An increase in group mean body weight was observed after 12 weeks. At higher dose levels (100 mg/Kg), depressed growth rate in the male rats was noted but the effect was not observed in female rats. At 50 mg/Kg, the depression in growth rate produced in the male rats was not significant. No abnormalities were found in the red and total white cell counts or hemoglobin concentration. None of the organ weights in the dosed group differed significantly (P: 0.05) from those of the controls. Histological examination of the organs did not reveal the abnormalities apart from slight and variable increase in the iron deposition in the tissue phagocytes. Based on the observation made, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 50 mg/Kg using albino rats of WAG strain.
Reference
Table: Effect of the test chemical on growth rate in rats
Dose |
Control |
Test group |
||
Male |
Female |
Male |
Female |
|
0 |
181 ± 13.6 |
92 ± 6.6 |
- |
- |
50 |
- |
- |
156 ± 11.7 |
101 ± 5.8 |
100 |
- |
- |
136 ± 12.8 |
87 ± 10.7 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
- Quality of whole database:
- Klimisch Rating 2
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated Dose toxicity- Oral
Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of the test chemical using rats. The study was performed on 5 male and 5 females rats per group at dose levels of 0, 50 or 100 mg/Kg for 12 weeks. The animals were observed for changes in body weight, hematology parameters, organ weight changes were noted and histological parameters were noted. An increase in group mean body weight was observed after 12 weeks. At higher dose levels (100 mg/Kg), depressed growth rate in the male rats was noted but the effect was not observed in female rats. At 50 mg/Kg, the depression in growth rate produced in the male rats was not significant. No abnormalities were found in the red and total white cell counts or hemoglobin concentration. None of the organ weights in the dosed group differed significantly (P: 0.05) from those of the controls. Histological examination of the organs did not reveal the abnormalities apart from slight and variable increase in the iron deposition in the tissue phagocytes. Based on the observation made, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 50 mg/Kg using albino rats of WAG strain.
Repeated dose toxicity -Inhalation A short-term toxicity study doesnot need to be conducted because exposure of humans via inhalation in production/use is not likely based on the thorough and rigorous risk assessment provided. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver
Repeated dose toxicity -Dermal A short-term toxicity study doesnot need to be conducted because exposure of humans via dermal route in production/use is not likely based on the thorough and rigorous risk assessment provided. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.
Justification for classification or non-classification
The test chemical can be regarded as potentially non-toxic when exposed repeatedly via oral, dermal and inhalation route of exposure. It can be classified under the category "Not Classified" as per CLP Regulation
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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