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EC number: 233-899-5 | CAS number: 10421-48-4
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 03.01.2003 to 26.01.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. Study not directly relevant based on the low pH of the submission substance and the low concentration tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iron sulphate
- EC Number:
- 231-753-5
- EC Name:
- Iron sulphate
- Cas Number:
- 7720-78-7
- IUPAC Name:
- iron(2+) sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Laboratory grade ferrous sulphate heptahydrate
- Substance type: Iron salt
- Physical state: Green solid
- Analytical purity: 99.5 %
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: 644G
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Ambient temperature in the dark.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Kent, UK
- Age at study initiation: 'Young'
- Weight at study initiation: 2327-3295 g
- Housing: Individually in 'cages suitable for animals of this strain'
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 30-70
- Air changes (per hr): Minimum of 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06.01.2003 To: 26.01.2003
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): as a 249 mg/l solution in water, equivalent to a 5% solution of Fe, which is typically the strongest solution used commercially. - Duration of treatment / exposure:
- Eyes not rinsed so no truncation of exposure occurred.
- Observation period (in vivo):
- Three days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein staining
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: one hour
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: three days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: one day
- Score:
- 3.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: two days
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: three days
- Score:
- 0
- Max. score:
- 110
- Irritant / corrosive response data:
- There were no corneal or iridial effects. Conjunctival effects were observed in all animals for up to two days and consisted of slight redness and slight chemosis. There were no other signs of irritation. Mean scores one hour, 24 hours or 48 hours after dosing were 4, 3.3 and 2. By the 72 hour assessment reactions had all resolved and the mean score was zero.
- Other effects:
- There were no signs of systemic toxicity. Instillation caused practically no or only slight initial pain.
Any other information on results incl. tables
Mild irritation, practically no initial pain response and all clear within 48 hours.
Scores were as follows:
Opacity. 0.0, 0.0 and 0.0
Iritis. 0.0, 0.0 and 0.0
Redness. 0.7, 0.7 and 0.3
Chemosis. 0.7, 0.0 and 0.3
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Iron sulfate heptahydrate (5% iron) was not irritating to the eyes of rabbits.
The EFSA conclusion (EFSA Journal 2012;10(1):2521; CONCLUSION ON PESTICIDE PEER REVIEW, Conclusion on the peer review of the pe
sticide risk assessment of the active substance iron sulfate
European Food Safety Authority) for iron sulphate irritancy was based on human data and the precautionary principle and on physical properties, and only one old reference with other citations in literature as moderate irritant without further evidence . For eye irritancy EFSA concluded Irritant (R36) (human data – precautionary, based on physical properties, only one old reference).
Aqueous solutions of iron trinitrate have low pH values, for a 5% aqueous solution of iron trinitrate nonahydrate the pH range was 1.5-2.5 and typically effective values were <2.0 (pH 1.5-1.7). These values would indicate potential corrosive properties for iron trinitrate and read across from iron sulphate (based on the results presented in this study summary) is not considered appropriate for assessment of iron trinitrate irritation.
- Executive summary:
0.1 ml of ferrous sulphate heptahydrate solution, a 249 mg/l solution in water, equivalent to a 5% solution of Fe, which is typically the strongest solution used commercially, was instilled into one eye of each of three rabbits. The treated eyes were asessed for changes over the following 72 hours and group mean scores calculated for standard eye irritation parameters. Conjunctival reactions resolved within 72 hours and no corneal or iridial changes were apparent. Iron sulfate heptahydrate (5% iron) was not irritating to the eyes of rabbits.
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