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EC number: 239-018-0 | CAS number: 14940-41-1
- 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:
- repeated dose toxicity: oral, other
- Remarks:
- combined repeated dose and reproductive/developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study summary available only. Original reference was not obtainable, but the study was approved by the OECD procedure on Mutual Acceptance of Data (MAD).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- reproductive toxicity, other
- Remarks:
- combined repeated dose and reproductive/developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study summary available only. Original reference was not obtainable, but the study was approved by the OECD procedure on Mutual Acceptance of Data (MAD).
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- not applicable
- Specific details on test material used for the study:
- not specified
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- males: 42 days
females: 42 - 54 days - Frequency of treatment:
- not specified
- Details on study schedule:
- not specified
- Dose / conc.:
- 125 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes, death
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE: Not specified - Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number of neonates, survival rate, and sex ratio of live neonates - Postmortem examinations (parental animals):
- ORGAN WEIGHTS: Yes
HISTOPATHOLOGY: Yes - Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- - there were female deaths in the 500 mg/kg bw/day group only.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - body weight gain was reduced in males by 21% in the 250 mg/kg bw/day group and by 37% in the 500 mg/kg bw/day group, and in females by 17% in the 250 and by 15% in the 500 mg/kg bw/day groups.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- - mean cell volume was increased by 7% in the 500 mg/kg bw/day male treatment group, and metheamoglobin decreased by up to 78% for females in the 125, 250 and 500 mg/kg bw/day treatment groups.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - cholinesterase was decreased in males by up to 41% at doses of 250 and 500 mg/kg bw/day.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological examination showed hemosiderin deposits in the hepatocytes, hyperplasia of the adrenals and zona fasciculata, hyperkeratosis of forestomach, hemosiderin deposits in the stomach, and neutrophil infiltration of submusoca in both sexes of the animals, at 500 mg/kg bw/day. In the case of decedent animals, severe villous atrophy of forestomach was observed; abnormalities of gastric function were detected. Therefore, it is concluded that deaths in female rats were caused by physical irritancy of the test substance.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- clinical biochemistry
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 55 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- Fe
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- clinical biochemistry
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: based on no significant difference in mating data and pre- and post-implantation loss rate.
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- 220 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- Fe
- Sex:
- male/female
- Remarks on result:
- other: based on no significant difference in mating data and pre- and post-implantation loss rate.
- Critical effects observed:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 220 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- Fe
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- not specified
- Reproductive effects observed:
- no
- Conclusions:
- This study found no indication of any reproductive toxicity in parent animals at the maximum tested dose of 500 mg/kg bw/day (equivalent to 220 mg Fe /kg bw/day). Therefore, the NOAEL for reproductive toxicity was 500 mg/kg bw/day.
The original reference could not be obtained and this study entry is based on an available study summary, but the study was approved by the OECD procedure on Mutual Acceptance of Data (MAD).
Following necropsy, there were no pathological changes of ovaries, testes and epididymides in treated animals.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
- there were no differences in mating rate between control and tested groups (93.3 % in control group, 86.7 % in 125 mg/kg bw/day group, 100 % in 250 mg/kg bw/day and 100 % in 500 mg/kg bw/day group).
- birth rate showed no difference between the treated and the control groups.
- there were no differences in fertility index (73.3%, 80.0%, 93.3%, and 66.7% for male rats, and 78.6%, 85.7%, 93.35, and 66.7% for female rats in control, 125 mg bw/kg/day, 250 mg/kg bw/day and 500 mg/kg bw/day groups), and gestation periods (23.6 d in control group, 22.1 d in 125 mg/kg bw/day group, 22.3 d in 250 mg/kg bw/day group and 22.1 d in 500 mg/kg bw/day group) between control and treated groups.
- pre-implantation loss rates (14.4 %, 9.4 %, 14.3 % and 9.8 % for the control, low, intermediate and high dose groups, respectively) and post-implantation loss (6.0 %, 6.0 %, 3.1 % and 7.0 %, respectively) were unaffected by treatment.
The survival rate at postpartum day 0, and survival rate at postpartum day 4 showed no difference between the treated and the control groups.
OTHER FINDINGS
The number of neonates showed no difference between the treated and the control groups.
The sex ratio of live neonates was not affected by ferrous chloride.
A single case of acaudia and decreased crown rump length on postpartum day 4 in 125 mg/kg/day group (i.e. no dose response relationship) were the only findings of note.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Iron dichloride
- EC Number:
- 231-843-4
- EC Name:
- Iron dichloride
- Cas Number:
- 7758-94-3
- Molecular formula:
- Cl2Fe
- Test material form:
- not specified
- Details on test material:
- not specified
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- not specified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- males: 42 days
females: 42 - 54 days - Frequency of treatment:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 125 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, death
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: Not specified
IMMUNOLOGY: Not specified - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes
HISTOPATHOLOGY: Yes - Statistics:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- - there were female deaths in the 500 mg/kg bw/day group only.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - body weight gain was reduced in males by 21% in the 250 mg/kg bw/day group and by 37% in the 500 mg/kg bw/day group, and in females by 17% in the 250 and by 15% in the 500 mg/kg bw/day groups.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- - mean cell volume was increased by 7% in the 500 mg/kg bw/day male treatment group, and metheamoglobin decreased by up to 78% for females in the 125, 250 and 500 mg/kg bw/day treatment groups.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - cholinesterase was decreased in males by up to 41% at doses of 250 and 500 mg/kg bw/day.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weight measurements showed that liver weights were increased by up to 24% absolute weight in intermediate and high dose animals of both sexes, with adrenal weights increased by up to 31% absolute weight, 61% relative weight in males and thymus weights decreased by up to 32% absolute weight, 27% relative weight in females from these same treatment groups (relative and absolute values altered in all instances).
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological examination showed hemosiderin deposits in the hepatocytes, hyperplasia of the adrenals and zona fasciculata, hyperkeratosis of forestomach, hemosiderin deposits in the stomach, and neutrophil infiltration of submusoca in both sexes of the animals, at 500 mg/kg bw/day. In the case of decedent animals, severe villous atrophy of forestomach was observed; abnormalities of gastric function were detected. Therefore, it is concluded that deaths in female rats were caused by physical irritancy of the test substance.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- URINALYSIS
- urinalysis showed no difference between control and treated groups.
GROSS PATHOLOGICAL FINDINGS
Following necropsy, there were no pathological changes of ovaries, testes and epididymides in treated animals.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- haematology
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Effect level:
- 55 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- Fe
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- haematology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was concluded to be 125 mg/kg/day for males and females, equivalent to 55 mg Fe/kg/day. This NOAEL is based on changes in body weight gain, liver and adrenal weight, mean cell volume and cholinesterase in males, and changes in body weight gain, liver and thymus weight and metheamoglobin in females.
The original reference could not be obtained and this study entry is based on an available study summary, but the study was approved by the OECD procedure on Mutual Acceptance of Data (MAD).
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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