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EC number: 215-268-6 | CAS number: 1317-37-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore it is considered relevant, reliable and adequate for classification.
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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Iron sulphide
- EC Number:
- 215-268-6
- EC Name:
- Iron sulphide
- Cas Number:
- 1317-37-9
- Molecular formula:
- FeS
- IUPAC Name:
- sulfanylideneiron
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar –HsdCpd: WU
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at treatment: 9-11 weeks
- Weight at treatment: 191.8-195.4g
- Fasting period before study: 16 - 18 hours (acces to water was not interrupted)
- Housing: Individually in standard polysulfone cages (Size approximately L 425 x B 266 x H 175 mm), with stainless steel top grill having facilities for pelletted food and drinking water; bedding: steam sterilized clean corn cob was used and changed along with the cage at least twice a week.
- Diet (e.g. ad libitum): Teklad Certified (2014C) Global 14% Protein Rodent Maintenance Diet-Pellet (Certified) manufactured by Harlan Laboratories B.V., Maasheseweg 87c PO Box 553, 5800, AN Venray, The Netherlands; ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India, in polycarbonate bottles with stainless steel sipper tubes; ad libitum
- Acclimation period: 5-15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 65-66%
- Air changes (per hr): 12-15/hour
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 28 June 2012 To: 27 July 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 3.9 mL
DOSAGE PREPARATION (if unusual):
The test item suspension was prepared on each day of the test item administration.
Steps 1-5: A quantity of 4.0 g of the test item was weighed to a precalibrated beaker *(previously calibrated to a 40 mL volume) and the volume was made up to the mark with Milli-Q water (vehicle) to get the desired concentration of 100 mg/mL. The preparations were stirred using a homogenizer for at least 10 minutes before dosing.
Homogeneity of the test item in the vehicle was maintained during treatment by constant stirring by using homogenizer. Preparations were made prior (within one hour) to dosing.
*Pre-calibration of the beaker to desired volume: 40 mL Milli-Q water was measured in a graduated cylinder. The measured water was transferred into a clean beaker (to be pre-calibrated) and upper and lower meniscus of water was marked on the beaker using a glass marker. Once line has been marked, the water was discarded and the beaker was dried. This line is used to make up to the upper line volume when preparing the dose formulations
CLASS METHOD (if applicable) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 5x on test day 1 and once daily during days 2-15; individual body weights: on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs of toxicity
- Gross pathology:
- There were no abnormalities detected at necropsy.
Any other information on results incl. tables
Table 1. Body weight, Body weight change and Pre-terminal deaths
Step and Dose (mg/kg Body weight) |
Rat No. |
Sex |
Body weight (g) |
||||
Initial (Day 1)
|
Day 8 |
Weight change (Day 8 – Initial) |
Day 15 |
Weight change (Day 15 – Initial) |
|||
Step 1 (2000) |
Rm921 |
F |
193.7 |
209.7 |
16.0 |
215.0 |
21.3 |
Step 2 (2000) |
Rm922 |
F |
191.8 |
217.5 |
24.7 |
223.8 |
31.0 |
Step 3 (2000) |
Rm923 |
F |
192.3 |
210.0 |
17.7 |
216.3 |
24.0 |
Step 4 (2000) |
Rm924 |
F |
192.5 |
210.6 |
18.1 |
217.2 |
24.7 |
Step 5 (2000) |
Rm925 |
F |
195.4 |
206.8 |
11.4 |
215.4 |
20.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the present study results, the estimated acute oral LD50 of Tribotecc® - Ferrostar is greater than 2000 mg/kg body weight in female rats.
- Executive summary:
An acute oral toxicity test (Up-and-Down Procedure) was conducted with female Wistar rats to determine the potential of Tribotecc® - Ferrostar to produce toxicity from a single dose via the oral route. The test item was suspended in Milli-Q water and was administered as a single oral dose to fasted (16 - 18 hours) rats. A limit test at 2000 mg/kg was initiated with one female rat. The first animal survived, and four additional animals were tested sequentially with the same dose. Those four animals survived, and the test was concluded. All animals were active, showed no clinical observations and gained body weight during 14 days observation period. All animals were subjected to necropsy at sacrifice and there were no abnormalities observed in any of the rats. Based on the present study results, the estimated acute oral LD50of Tribotecc® - Ferrostar is greater than 2000 mg/kg body weight in female rats.
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