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EC number: 257-446-6 | CAS number: 51818-55-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Iron trichloride
- Author:
- OECD
- Year:
- 2 007
- Bibliographic source:
- OECD HPV Chemical Programme, SIDS Dossier, approved at SIAM 24 (17-20 April 2007)
- Report date:
- 2007
- Reference Type:
- other: secondary source
- Title:
- Oral subchronic toxicity studies of ferric chloride in F344 rat.
- Author:
- Sato H. et al.
- Year:
- 1 985
- Bibliographic source:
- Bulletin of National Institute of Hygienic Sciences (Tokyo) 103, 21-28
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- trichloroiron;hexahydrate
- EC Number:
- 600-047-2
- Cas Number:
- 10025-77-1
- Molecular formula:
- FeCl3 x 6H2O
- IUPAC Name:
- trichloroiron;hexahydrate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ferric chloride hexahydrate
- Physical state: Solid
- Analytical purity: 98.5%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Ferric chloride was dissolved in water at concentrations of 0 (control), 0.12, 0.25, 0.5, 1.0 or 2.0 % (w/v) - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 98 days
- Frequency of treatment:
- Continuous
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.12 other: % w/v in water
- Remarks:
- equivalent to approximately 80 mg/kg bw/day in male rats, 88 mg/kg bw/day in female rats.
- Dose / conc.:
- 0.25 other: % w/v in water
- Remarks:
- equivalent to approximately 154 mg/kg bw/day in male rats, 176 mg/kg bw/day in female rats.
- Dose / conc.:
- 0.5 other: % w/v in water
- Remarks:
- equivalent to approximately 277 mg/kg bw/day in male rats, 314 mg/kg bw/day in female rats.
- Dose / conc.:
- 1 other: % w/v in water
- Remarks:
- equivalent to approximately 550 mg/kg bw/day in male rats, 571 mg/kg bw/day in female rats.
- Dose / conc.:
- 2 other: % w/v in water
- Remarks:
- equivalent to approximately 1231 mg/kg bw/day in male rats, 1034 mg/kg bw/day in female rats.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- This is a dose-range finding study to determine doses for a two-year carcinogenicity study. No satellite group included.
Examinations
- Observations and examinations performed and frequency:
- The following test parameters such as biochemical and haematological endpoints, body and organ weights and water consumption were recorded.
- Body weights and water consumption were recorded weekly throughout the test period.
- Biochemical endpoints evaluated were: GOT, GPT, LDH, ALP, TC, TGL, TP, A/G, BUN, CR, UA, Fe (males)
- Haematological endpoints were: RBC, WBC
The dose of feric chloride in mg/kg/day was calculated from the drinking water intake and the final weight of male and female rats. - Sacrifice and pathology:
- - Organ weights recorded: Salivary gland, thymus, lung, heart, liver, spleen, adrenal, kidney, gonads, brain, pituitary.
- Histopathological examination was carried out with special staining for iron deposition using Berlin Blue reaction. - Other examinations:
- n.a.
- Statistics:
- Statistical analysis performed, no further information
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- - Mortality: None of the animals in any of the groups died during the 13-week period of the study.
- Body weight: There was a statisitcally significant dose related decrease in male body weight (1% level of significance) at 0.5% and above and a statisitcally significant decrease in female body weight at 2% (1% level) and 1% (5% level). Decreased on body weight for male rats were of the order of 46%, 26% and 10% of controls for the 2%, 1% and 0.5% dose levels, respectively. In females there was a 20% reduction at 2% and a 6% reduction at 1%.
- Water consumption: There was a significant suppression in the intake of drinking water observed in groups given concentrations of 0.5% or more (no further detail).
- Haematology: Males of the treated groups had significantly increased red blood cell counts (no further details).
- Clinical Chemistry: Higher levels of serum iron were observed in males (control: 102 ± 5 g/dl; 0.12%: 107 ± 11 g/dl; 0.25%: 109 ± 8 g/dl; 0.5%: 129 ± 22 g/dl; 1.0%: 139 ± 10 g/dl; 2.0%: 156 g/dl).
Gross pathology:
No findings reported.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.5 other: % w/v in drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Table
1_Doses: The dose of feric chloride in mg/kg
bw/day was calculated from the drinking water intake and the final weight of male and female rats
Dose of ferric chloride hexahydrate | Final weight (kg) | Final daily water intake (mL/d) | Dose (mg/kg bw/day) | ||||
% | mg/L | Males | Females | Males | Females | Males | Females |
0 | 0 | 0.35 | 0.195 | 23.5 | 15 | 0 | 0 |
0.12 | 1.2 | 0.345 | 0.19 | 23 | 14 | 80 | 88 |
0.25 | 2.5 | 0.34 | 0.185 | 21 | 13 | 154 | 176 |
0.5 | 5.0 | 0.325 | 0.175 | 18 | 11 | 277 | 314 |
1.0 | 10.0 | 0.3 | 0.175 | 16.5 | 10 | 550 | 571 |
2.0 | 20.0 | 0.195 | 0.145 | 12 | 7.5 | 1231 | 1034 |
Applicant's summary and conclusion
- Conclusions:
- In conclusions, the NOAEL derived from a 90-day repeated dose toxicity study in rats was 0.5% (equivalent to 277 and 314 mg/kg bw/day in males and females, respectively).
- Executive summary:
Iron trichloride hexahydrate (98.5% purity) was administered to Fischer 344 rats (10/sex/dose) in their drinking water for 13 weeks, at concentrations of 0.12, 0.25, 0.5, 1.0 and 2.0 % FeCl3 (equivalent to approximately 80, 154, 277, 550 and 1231 mg/kg bw/day in male rats, 88, 176, 314, 571 and 1034 mg/kg bw/day in female rats). All deaths and clinical signs of toxicity were recorded. Body weights were measured weekly. At the end of the dosing period, all survivors were killed for haematological, clinical chemistry and pathological exminations. All major organs and tissues were examined microscopically. There were no deaths or clinical signs of toxicity. There was a significant reduction in body weight gains at the two highest doses at the end of the treatment period. Treated males had increased levels of serum iron and higher red blood cell counts compared with controls. The NOAEL was 0.5 % (equivalent to 277 and 314 mg/kg bw/day in males and females, respectively) based on the reduced body weight gain.
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