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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- 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:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at treatment: 11 to 12 weeks
- Weight at treatment: Males: 254.39 to 273.81 g; Females: 203.10 to 210.6 g
- Fasting period before study: Not provided
- 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; water bottles were replenished once daily and changed once a week
- Acclimation period: Females: 5 days; Males: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 64-66%
- Air changes (per hr): 12-15/hour
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: June 1, 2012 To: June 22, 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Milli-Q water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsolateral thorax
- % coverage: about 10% of body surface
- Type of wrap if used: cotton gauze secured in position by adhesive tape wound around torso
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and with Johnson’s Baby Soap and next with water
- Time after start of exposure: after 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: Based on the individual body weight, the test item at the dose of 2000 mg/kg bw was weighed on an aluminum foil and made into a paste by adding sufficient volume of Milli-Q water.
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): sufficient volume to make a paste - Duration of exposure:
- 24 hours
- 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: 4 times on day 1 and once daily during days 2-15; individual body weights on day 1 (pre-application), 8 (7 days post application) and 15 (14 days post application
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- There were no skin reactions observed at the site of application. There was no abnormality detected at necropsy.
Any other information on results incl. tables
Table 1 Body Weight, Body Weight Changes and Pre-Terminal Deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
No.dead / No.tested |
Pre- terminal deaths (%) |
||||
Initial |
8th day |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
|||||
G1 2000
|
Rm881 |
F |
203.72 |
212.33 |
8.61 |
225.92 |
22.20 |
0/10 |
0 |
Rm882 |
F |
204.81 |
214.39 |
9.58 |
230.06 |
25.25 |
|||
Rm883 |
F |
204.97 |
215.08 |
10.11 |
228.62 |
23.65 |
|||
Rm884 |
F |
203.10 |
211.91 |
8.81 |
226.11 |
23.01 |
|||
Rm885 |
F |
210.06 |
218.17 |
8.11 |
230.90 |
20.84 |
|||
Rm886 |
M |
267.52 |
279.60 |
12.08 |
298.15 |
30.63 |
|||
Rm887 |
M |
270.40 |
281.64 |
11.24 |
299.69 |
29.29 |
|||
Rm888 |
M |
258.31 |
267.80 |
9.49 |
286.33 |
28.02 |
|||
Rm889 |
M |
254.39 |
268.62 |
14.23 |
286.36 |
31.97 |
|||
Rm890 |
M |
273.81 |
290.03 |
16.22 |
304.80 |
30.99 |
F: Female; M: Male
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the present study results, the acute dermal LD50 of Tribotecc® - Ferrostar is greater than 2000 mg/kg body weight in male and female Wistar rats.
- Executive summary:
An acute dermal toxicity test was conducted with Wistar rats (male and female) to determine the potential toxicity for iron sulfide (Tribotecc® - Ferrostar) to produce toxicity from a short term exposure via the dermal route. The test item at the dose of 2000 mg/kg body weight (based on the individual body weight of rats) was weighed on an aluminum foil and made into a paste by adding sufficient volume of Milli-Q water. The prepared paste was completely transferred on to the cotton gauze (size: males: 9 x 6 cm; Females: 8 x 5 cm of 6 ply) and was applied on to the clipped dorsolateral thoracic surface of the skin of the rats to cover about 10% of body surface of the animal and it was secured in position by adhesive tape wound around torso. The test item contact period with the skin was for 24 hours. After the 24 hour contact period, the dressing was removed and the applied area was washed with water and with Johnson’s Baby Soap (Johnson & Johnson U.S.A.®J&J*TM) and again with water. Washed animals were wiped dry with a cotton hand towel. The treatment was initiated in 5 female rats at the dose of 2000 mg/kg body weight. There were no clinical signs of toxicity, local skin reactions or mortality observed, hence 5 male rats were treated at the same dose of 2000 mg/kg body weight. All the rats were observed for clinical signs of toxicity, local skin reactions and mortality for 14 days post application. There were no clinical signs of toxicity, local skin reactions or mortality. At the end of observation period, all surviving animals were euthanized and subjected to necropsy. There were no abnormalities detected at the necropsy. Based on the present study results, the acute dermal LD50 of Tribotecc®-Ferrostar is greater than 2000 mg/kg body weight in male and female Wistar rats.
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