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EC number: 231-768-7 | CAS number: 7723-14-0
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 11 August 2011 - 08 March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD test guidelines, and in compliance with GLP, so the data is considered reliable without restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- triiron phosphide
- IUPAC Name:
- triiron phosphide
- Reference substance name:
- Triiron phosphide
- EC Number:
- 234-682-8
- EC Name:
- Triiron phosphide
- IUPAC Name:
- 234-682-8
- Reference substance name:
- 12023-53-9
- Cas Number:
- 12023-53-9
- IUPAC Name:
- 12023-53-9
- Details on test material:
- - Name of test material (as cited in study report): Fe3P, Ferrophosphorous
- Physical state: Solid (fine powder)
- Analytical purity:Phosphorous 16.0%, Carbon 0.61%, Iron as base.
- Purity test date: 24 Jan 2011
- Lot/batch No.: 1192691
- Expiration date of the lot/batch: 31 December 2011
- Storage condition of test material: Ambient temperature
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 72 days
- Weight at study initiation: 348 - 399g (males), 230 - 287g (females)
- Housing: Polycarbonate cages with either stainless steel grid floors during mating, and solid poly carbonate floors during other phases of testing.
- Diet (e.g. ad libitum): ad libitum / free access, except overnight before routine blood sampling
- Water (e.g. ad libitum): ad libitum / free access
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light: 12 hours dark
IN-LIFE DATES: From: 26 October 2011 (Treament commenced) To: 12 December 2011 (Last date of necropsy for main phase females)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Aqueous methylcellulose
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Concentration in vehicle: 10 - 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulation samples were analysed by Atomic Absorption Spectrometry, to determine Iron in the samples.
Prior to the start of treatment, the analytical method was validated with respect to specificity, limit of detection, linearity of detector response over the calibration range, precision of measurement at the lowest and highest calibration standards, and the accuracy and precision of the method, by the determination of six procedural recoveries at 1 mg/mL and 100 mg/mL. A stability tiral was also performed; formulations were found to be stable and homogenous for up to 2 hours at ambient temperature with paddle stirring, and following 15 days' refrigerated storage.
Samples from all formulations prepared in the first and last weeks of the study were analysed; the test material concentrations were found to be within acceptable limits, confirming accurate preparation. - Duration of treatment / exposure:
- Main phase males and toxicity phase females were dosed for five consecutive weeks.
Main phase females were treated daily for two weeks before pairing, throughout mating, gestation and until day 6 of lactation. - Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Main phase - 10 animals per sex per dose
Toxicity phase - 5 females per dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were decided in a 7-day preliminary study in rats, conducted at the same laboratory - refer to "7 Day rangefinding_Huntingdon Life Sciences, 2011 (FGE0026)".
- Post-exposure recovery period in satellite groups: Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Prior to the start of treatment, and at least weekly for males and toxicity phase females. Main phase females were observed weekly before pairing, and on days 0, 6, 13 and 20 after mating, and days 1 and 7 of lactation.
BODY WEIGHT: Yes
- Time schedule for examinations: Main phase males and toxicity phase females were weighed on day 0 of treatment, then weekly and beofre necropsy. Main phase females were weighed on day 0 of treatment and weekly until mating was detected, and days 0, 6, 13 and 20 after mating, and on days 1, 4 and 7 of lactation.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/week: Yes
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
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Week 5 of treatment for 5 of the main phase males and for the toxicity phase females.
- Anaesthetic used for blood collection: Yes - isoflurane
- Animals fasted: Yes
- How many animals: As above
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: conducted at the same time and using the same animals as Haematology, above.
- Parameters checked in table 2 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: Sensory reactivity and grip strength measured in the first five males for the main phase, and all five females of the toxicity phase during week 5 of treatment. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see tables 3 and 4)
HISTOPATHOLOGY: Yes (see table 5)
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
During the study there were no signs that were considered to be related to the administration of Fe3P and no unscheduled deaths.
BODY WEIGHT AND WEIGHT GAIN
Bodyweight gain for males during the five weeks of treatment was unaffected by the administration of Fe3P.
Bodyweight gain for females during the first two weeks of treatment was considered to be unaffected by the administration of Fe3P. Toxicity phase females had lower bodyweight gain between weeks three and five of treatment (max 47% of Control) along with a lower overall bodyweight gain over the five weeks of treatment (max 60% of Control). However, there was no dose response and a relationship to treatment is uncertain.
Bodyweight gain for gestating females was considered the be unaffected by the administration of Fe3P, however lactating females given Fe3P at 300 and 1000 mg/kg/day had marginally lower bodyweight gain between days one and seven of lactation (max 82% of Control)
FOOD CONSUMPTION
Food consumption for males was considered to be unaffected by the administration of Fe3P.
During the first two weeks of treatment female food consumption was considered to be unaffected by the administration of Fe3P. Toxicity phase females showed some intergroup variation in food consumption during week 3 of treatment. During Weeks four and five food consumption was marginally lower in those animals given Fe3P (94% and 90% of Controls respectively). However, there was no dose response and a relationship to treatment is uncertain.
Food consumption for gestating and lactating females, with the exception of females given 1000 mg/kg/day, was considered to be unaffected by the administration of Fe3P. Females given 1000 mg/kg/day had marginally lower food consumption over the seven days of lactation when compared to Controls.
HAEMATOLOGY
Haematological parameters in both males and females in Week 5 of treatment were considered to be unaffected by the administration of Fe3P. Males given 300 or 1000 mg/kg/day had slightly low haematocrit and haemoglobin concentrations which attained statistical significance when compared to control, but there were no similar effects in females.
CLINICAL CHEMISTRY
Blood chemistry parameters in males and females in Week 5 of treatment were considered to be unaffected by the administration of Fe3P.
ORGAN WEIGHTS
There was no effect of treatment on organ weights for males receiving Fe3P.
Intergroup variability in uterine weight did not appear to follow any dose related pattern and may relate to differences in the stage of the oestrous cycle at necropsy.
GROSS PATHOLOGY
The macroscopic examination performed after 5 weeks of treatment revealed no test substance related lesions.
The nature and incidence of all findings were consistent with the commonly seen background of macroscopic changes.
HISTOPATHOLOGY
Microscopic examination was performed on the first five Main phase males killed at scheduled termination and Toxicity phase females in the Control and high dose group (1000 mg/kg/day).
In all the tissues examined, there was no evidence of changes considered related to the treatment with the test compound.
The seminiferous tubules of the testes were evaluated with respect to their stage in the spermatogenic cycle and the integrity of the various cell types present within the different stages. No cell or stage abnormalities were noted.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 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
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- mortality
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral administration of Fe3P to Sprague-Dawley rats for at least 5 weeks at doses of 100, 300 and 1000 mg/kg/day was generally well tolerated with no toxicologically
significant systemic effects.
Based on the results from this study, for general toxicity the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day.
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