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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- 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.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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% (w/v) aqueous methylcellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Concentration in vehicle: 10 - 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw/day - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Up to two weeks, or until evidence of mating was found
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of gestation
- After successful mating each pregnant female was caged (how): Individually - 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
- Details on study schedule:
- - Age at mating of the mated animals in the study: Approximately 12 weeks
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 males and 10 females 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)".
Examinations
- Parental animals: Observations and examinations:
- Refer to Study Summary in section 7.5.1.
- Oestrous cyclicity (parental animals):
- For 15 days before pairing, daily vaginal smears (dry) were taken from all Main phase females, using cotton swabs moistened with saline. The smears were subsequently examined to establish the duration and regularity of the oestrous cycle. After pairing with the Main phase male, smearing was continued using pipette lavage, until evidence of mating was observed.
- Sperm parameters (parental animals):
- Parameters examined in male parental generations: testis weight, epididymis weight.
Seminal vesicles were subject to histopathological examination. - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: No
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
Clinical signs, litter size, Sex ratio, and bodyweight
GROSS EXAMINATION OF DEAD PUPS:
For offspring surviving to scheduled termination, a careful external examination for gross abnormalities was performed. Offspring that appeared normal externally were discarded without internal examination. Offspring which were externally abnormal were subjected to a full internal microscopic examination. Missing offspring and those grossly autolysed or cannibalised could not be examined; all other offspring which died before day 7 of age were examined as detailed. The necropsy also included an assessment for the presence of milk in the stomach, where possible. - Postmortem examinations (parental animals):
- Refer to Gross Pathology and Histopathology in section 7.5.1.
- Postmortem examinations (offspring):
- Microscopic examination, as described in "Litter Observations", above.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- Assessment of oestrous cycles during the two week pre-pairing period showed that nearly all of the main phase females had regular 4 or 4/5 day oestrous cycles and it was considered that this parameter was not affected by treatment with Fe3P.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- 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.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The pre-coital interval was unaffected by treatment, with animals mating at the earliest opportunity, when the female came into oestrus.
Mating performance and fertility as assessed by percentage mating, conception rate and fertility index, were unaffected by treatment.
The gestation length was within the normal range of 22 to 23 days for all animals and the gestation index was unaffected by treatment.
food
Details on results (P0)
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
Assessment of oestrous cycles during the two week pre-pairing period showed that nearly all of the main phase females had regular 4 or 4/5 day oestrous cycles and it was considered that this parameter was not affected by treatment with Fe3P.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
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.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
The pre-coital interval was unaffected by treatment, with animals mating at the earliest opportunity, when the female came into oestrus.
Mating performance and fertility as assessed by percentage mating, conception rate and fertility index, were unaffected by treatment.
The gestation length was within the normal range of 22 to 23 days for all animals and the gestation index was unaffected by treatment.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
The mean number of implantations and the live litter size on Days 1, 4 and 7 were similar to control values and unaffected by treatment.
Offspring survival up to Day 7 of age was unaffected by parental treatment.
CLINICAL SIGNS (OFFSPRING)
Refer to table in "Any other information on results".
BODY WEIGHT (OFFSPRING)
Mean bodyweights of male and female offspring of all groups of parents treated with Fe3P were marginally lower than in Controls on Day 1 of age but differences did not attain statistical significance and there was considered to be no effect of treatment on mean bodyweight gains of the offspring between Days 1 and 4 of age. However, between Day 4 and Day 7 of age, mean bodyweight gains of male and female offspring of all groups of parents treated with Fe3P were lower than in Controls and the differences attained statistical significance in the 1000 or 300 mg/kg/day groups (77-80% of Controls) and they showed a dose response. Overall bodyweight gain, between Days 1-7, was statistically lower in all male offspring of all groups of parents treated with Fe3P.
GROSS PATHOLOGY (OFFSPRING)
Macroscopic examination of offspring dying before scheduled termination or killed at scheduled termination on Day 7 of age did not reveal any findings that were attributed to parental treatment.
OTHER FINDINGS (OFFSPRING)
Sex ratio, as expressed in terms of % males, was not affected by parental treatment.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- sexual maturation
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Summary of offspring clinical observations
Observation |
Group (Dose mg/kg/day) |
|||
1 (0) |
2 (100) |
3 (300) |
4 (1000) |
|
Number of offspring (litters) affected |
||||
Head: bruising and swelling |
1(1) |
|
|
|
Head: bruising |
|
1(1) |
1(1) |
1(1) |
Umbilical cord attached |
1(1) |
|
|
|
Missing |
2(2) |
|
1(1) |
2(2) |
Tail absent |
1(1) |
|
|
|
Dorsal surface: Scab and reddening |
|
1(1) |
|
|
Found dead |
|
1(1) |
|
|
Forepaw: Scab |
|
1(1) |
|
|
Colour: Pale |
|
|
1(1) |
|
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for Fe3P for reproductive and developmental effects was considered to be 1000 mg/kg/day.
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