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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
Endpoint summary
Administrative data
Description of key information
Key studies were available for iron sulfide for oral and dermal acute toxicity, both showing LD50 values above 2000 mg/kg bw with absence of clinical or pathological observations. For read across purpose, comparison with a worst case source chemical iron dichloride was made, showing systemic effects and lethality after (300 and) 2000 mg/kg bw. Therefore iron sulfide is safe compared to more water soluble iron salts, most probably due to limited water solubility and limited systemic absorption.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- See attached read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Vehicle:
- corn oil
- Mortality:
- All animals received 2000 mg/kg body weight died after one hour and one animal received 300 mg/kg body weight was found dead on day 2.
- Clinical signs:
- other: Hypoactivity, piloerection, prone position, reddening and edema on ears, fore-legs and hind-legs, dyspnea, incomplete eyelid opening and hypothermia were observed in the three dead animals of 2000 mg/kg and in one dead animall of 300 mg/kg group. These si
- Gross pathology:
- No abnormalities were observed in all survived animals. At 2000 mg/kg body weight, nasal discharge (reddish or clear) was observed in all animals externally. Hemorrhage on lymphatic nodes, stomach and intestine in all animals and hemorrhage on thymus in one animal were observed. One animal showed hypertrophy of pancreas and other one animal showed the hypertrophy of spleen.
At 300 mg/kg body weight, hemorrhage on lymphatic nodes, and intestine were observed in the dead animal. And there was no abnormality by the macroscopic examination of survived animals after the study termination on day 15. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- All animals dosed at 2000 mg/kg body weight and one animal dosed at 300 mg/kg body weight were found dead. The acute lethal oral dose (LD50 cut-off values) to rats of the test article, Iron dichloride was estimated to be between 300 and 2000 mg/kg body weight under the test conditions.
- Executive summary:
Three female Sprague-Dawly rats were administered 300 mg/kg bw read-across substance iron dichloride by single oral gavage prepared in corn oil according to Acute Toxic Class method. Formulations were administered by single oral gavage at a dose volume of 10 mL/kg body weight. After the test article has been administered, food was withheld for 3 to 4 hours. Since no mortality was observed in this first group, three additional rats were administered 300 mg/kg bw Iron dichloride by single oral gavage. One animal of this second group was found dead on day 2. Three additional rats were tested at the limiting dose of 2000 mg/kg bw. All animals that received 2000 mg/kg body weight died after one hour. Hypoactivity, piloerection, prone position, reddening and edema on ears, fore-legs and hind-legs, dyspnea, incomplete eyelid opening and hypothermia were observed in the three dead animals of 2000 mg/kg and in one dead animall of 300 mg/kg group. These signs were considered to be distressful and painful symptoms caused by acute systemic toxicity of the test article. At 300 mg/kg body weight, all animals showed hypoactivity and piloerection on day 1. Some animals showed soft stool on day 2, but these symtoms were recovered. All survived rats gained normal body weight throughout the study. No abnormalities were observed in all survived animals. At 2000 mg/kg body weight, nasal discharge (reddish or clear) was observed in all animals externally. Hemorrhage on lymphatic nodes, stomach and intestine in all animals and hemorrhage on thymus in one animal were observed. One animal showed hypertrophy of pancreas and other one animal showed the hypertrophy of spleen. At 300 mg/kg body weight, hemorrhage on lymphatic nodes, and intestine were observed in the dead animal. And there was no abnormality by the macroscopic examination of survived animals after the study termination on day 15. The acute oral LD50 to rats of the read-across test article, Iron dichloride was estimated to be between 300 and 2000 mg/kg bw under the test conditions.
Reference
Table 1. Mortality and clinical signs
Group |
Dose (mg/kg) |
Animal No. |
Clinical signs observed in days after treatment |
Mortality (%) |
|||||
Hours on day 1 after treatment |
Day 2 |
Day 3-15 |
|||||||
1 |
2 |
3 |
4 |
||||||
1 |
300 |
F1 |
H, P |
H, P |
H, P |
H |
N |
N |
0/3 (0) |
F2 |
H, P |
H, P |
H, P |
H |
Ss |
N |
|||
F3 |
H, P, S |
H, P |
H, P |
H |
Ss |
N |
|||
2 |
300 |
F4 |
H, P |
H, P |
H, P |
H |
N |
N |
1/3 (33) |
F5 |
P |
H, P |
H, P |
H |
Ss |
N |
|||
F6 |
H.Le.P.Pp |
H.Le.P.Pp |
Dy.H.Le.P.Pp |
Ht.H.Le.P.Pa |
FD |
- |
|||
3 |
2000 |
F7 |
H.P.Pp.† |
|
FD |
|
- |
- |
3/3 (100) |
F8 |
H.P.Pp.Di.† |
|
FD |
|
- |
- |
|||
F9 |
H.P.Pp.† |
|
FD |
|
- |
- |
Dy: Dyspnea; FD: Found Dead; H: Hypoactivity; Ht: Hypothermia; Ie: Incomplete eyelid opening;
N: Normal; P: Piloerection; Pa: Pale; Pp: Prone position; S: Salivation; Ss: Soft stool; Di: Diarrhea;
†: Reddish change and edema on ears, fore-legs and hind-legs.
Table 2. Summary of group mean body weights
Group |
Dose (mg/kg) |
Mean body weight ± S.D. (g) |
||
Day 1 |
Day 8 |
Day 15 |
||
1 |
300 |
163.9 ± 6.9 |
206.6 ± 6.3 |
228.7 ± 12.5 |
2* |
300 |
161.6 ± 1.7 |
207.4 ± 7.7 |
226.7 ± 6.6 |
3** |
2000 |
162.5 ± 6.1 |
- |
- |
* One animal was found dead 2 days after administration.
** All animals were found dead 2 days after administration.
Table 3. Gross necropsy findings (Group summary)
Group |
1 |
2 |
3 |
||
Dose (mg/kg) |
300 |
300 |
2000 |
||
Number of animals examined at terminal kill |
3 |
3 |
3 |
||
External Finding |
No gross finding Reddish nasal discharge Clear nasal discharge |
|
|
|
|
Internal Finding |
No gross finding |
3 |
2 |
|
|
Hemorrhage |
Intestine Lymphatic node Ovaries Pancreas Stomach Thymus |
|
1 1 1 |
3 3
2 1 1 |
|
Hypertrophy |
Pancreas Spleen |
|
|
1 1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- See attached read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Limit test:
- yes
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- During the study, there was no unscheduled death.
- Clinical signs:
- other: Yellowish-brown change on the skin of applied site was observed in all treated animals from day 2 but this sign was recovered on day 15 except 3 animals. 2 males and 4 females showed the reddish nasal discharge on day 2. See Table 1
- Gross pathology:
- Internally, no abnormalities were observed in all animals by microscopic examination. On application sites, scars were observed in one male and
one female (see Table 3). - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dose (LD50 values) of iron dichloride to rats by single dermal administration was considered to be greater than 2000 mg/kg body weight under the conditions of this study.
- Executive summary:
In a classic dermal acute toxicity study, 5 male and 5 female Sprague-Dawley rats were clipped their fur on dorsal part approximately 10 % of the total body surface area one day before dosing. The read-across test article Iron dichloride was weighed and wetted with corn oil. The limit tests at one dose level of 2000 mg/kg body weight were performed. The test article was applied uniformly and held in contact with the skin with a porous gauze dressing and non-irritating tape for 24-hour exposure period. At the end of the exposure period, residual test article was removed using distilled water. During the study, there was no unscheduled death. Yellowish-brown change on the skin of applied site was observed in all treated animals from day 2 but this sign was recovered on day 15 except 3 animals. 2 males and 4 females showed the reddish nasal discharge on day 2. All rats gained normal body weight throughout the study. Internally, no abnormalities were observed in all animals by microscopic examination. On application sites, scars were observed in one male and one female. The acute lethal dose (LD50 values) of iron dichloride to rats by single dermal administration was considered to be greater than 2000 mg/kg body weight under the conditions of this study.
Reference
Table 1. Mortality and clinical signs (1 dose group: 2000mg/kg nw)
Sex |
Animal No. |
Clinical signs observed in days after treatment |
Mortality (%) |
||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||
male |
M1 |
N |
Ya |
Ya |
Ya |
† |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0/5 (0) |
M2 |
N |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
† |
† |
† |
† |
N |
N |
N |
||
M3 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
N |
N |
N |
||
M4 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
† |
† |
† |
† |
† |
† |
† |
N |
N |
N |
||
M5 |
N |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
N |
N |
N |
||
female |
F6 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
† |
0/5 (0) |
F7 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
† |
||
F8 |
N |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
† |
||
F9 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
† |
† |
† |
N |
N |
N |
||
F10 |
N |
Ya, Nd |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
Ya |
† |
† |
N |
N |
N: Normal
Nd: Red nasal discharge
Ya: Yellowish-brown change on application sites
†: Slight yellowish-brown change on application sites.
Table 2. Summary of group mean body weights
Sex |
Animal number |
Body weight (g)
|
||
Day 1 |
Day 8 |
Day 15 |
||
Male |
M1 |
275.1 279.7 266.2 265.8 256.9 268.7 ± 8.89 |
312.8 319.7 286.6 310.7 293.9 304.7 ± 13.88 |
360.1 379.1 329.7 369.2 331.7 354.0 ± 22.28 |
M2 |
||||
M3 |
||||
M4 |
||||
M5 |
||||
Mean ± SD |
||||
Female |
F6 |
225.1 232.3 226.9 233.5 223.8 228.3 ± 4.34 |
243.2 241.6 242.9 245.5 231.2 240.9 ± 5.59 |
253.3 250.0 260.6 269.1 252.2 257.0 ± 7.83 |
F7 |
||||
F8 |
||||
F9 |
||||
F10 |
||||
Mean ± SD |
Table 3. Gross necropsy findings (Group summary)
Dose (mg/kg/day) |
2000 |
||
Sex |
Male |
Female |
|
Number of animals examined |
5 |
5 |
|
External finding |
No gross finding Scar on applied site |
4 1 |
4 |
Internal finding |
No gross finding |
5 |
5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study
Additional information
A key acute oral toxicity test (Up-and-Down Procedure) was conducted with female Wistar rats to determine the potential toxicity of iron sulfide (Tribotecc® - Ferrostar) after a single dose via the oral route (Mohan Kumar, 2012a). 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 LD50 of iron sulfide is greater than 2000 mg/kg body weight in female rats. In a support read across oral acute toxicity study (acute toxic class method) iron dichloride was given in female Sprague-Dawly rats at 300 and 2000 mg/kg bw in corn oil (OECD SIDS, 2004). No mortality was observed at 300 mg/kg bw, so 3 additional rats were administered 300 mg/kg bw iron dichloride, with one animal found dead on day 2. Three additional rats were tested at the limiting dose of 2000 mg/kg bw, which all died after one hour. Hypoactivity, piloerection, prone position, reddening and edema on ears, fore-legs and hind-legs, dyspnea, incomplete eyelid opening and hypothermia were observed in the three dead animals of 2000 mg/kg and in one dead animal of 300 mg/kg group. These signs were considered to be distressful and painful symptoms caused by acute systemic toxicity of the test article. At 300 mg/kg body weight, all animals showed hypoactivity and piloerection on day 1. Some animals showed soft stool on day 2, but these symptoms were recovered. All survived rats gained normal body weight throughout the study. No abnormalities were observed in all survived animals. At 2000 mg/kg body weight, nasal discharge (reddish or clear) was observed in all animals externally. Hemorrhage on lymphatic nodes, stomach and intestine in all animals and hemorrhage on thymus in one animal were observed. One animal showed hypertrophy of pancreas and other one animal showed the hypertrophy of spleen. At 300 mg/kg body weight, hemorrhage on lymphatic nodes, and intestine were observed in the dead animal. And there was no abnormality by the macroscopic examination of survived animals after the study termination on day 15. The acute oral LD50 to rats of iron dichloride was estimated to be between 300 and 2000 mg/kg bw under the test conditions.
An acute dermal toxicity test was conducted with Wistar rats (male and female) to determine the potential toxicity for iron sulfide (Tribotecc® - Ferrostar) after 24h exposure via the dermal route. The test item at the dose of 2000 mg/kg body weight prepared as a paste was applied occlusively on the dorsolateral thoracic skin to cover about 10% of body surface of the animal. After the 24 hours the dressing was removed and the applied area was washed and wiped dry. 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. There were no clinical signs of toxicity, local skin reactions or mortality. There were no abnormalities detected at the necropsy. Based on the present study results, the acute dermal LD50of Tribotecc®-Ferrostar is greater than 2000mg/kg body weight in male and female Wistar rats. In a support read across dermal acute toxicity study (classic method), 5 male and 5 female Sprague-Dawley rats were treated with iron dichloride in corn oil at 2000 mg/kg body weight under semi-occlusive dressing for 24-hour exposure period (OECD SIDS, 2004). At the end of the exposure period, residual test article was removed using distilled water.During the study, there was no unscheduled death. Yellowish-brown change on the skin of applied site was observed in all treated animals from day 2 but this sign was recovered on day 15 except 3 animals. 2 males and 4 females showed reddish nasal discharge on day 2, and all rats gained normal body weight throughout the study. Internally, no abnormalities were observed in all animals by microscopic examination. On application sites, scars were observed in one male and one female.The acute lethal dose (LD50values) of iron dichloride to rats by single dermal administration was considered to be greater than 2000 mg/kg body weight under the conditions of this study.
The inhalation route was not considered appropriate based on low vapour pressure (for metals in general) and high particle size (d10 = 6.71 µm, d50 = 34.5 µm and d90 =65.4 µm), which are too large for reaching the alveoli of the lungs, therefore inhalation testing was not performed.
From the read across between the acute studies with iron dichloride (source chemical) and iron sulfide (target chemical), it is clear that iron dichloride is more toxic due to its corrosive properties, but also due to higher water solubility most probably leading to higher systemic absorption (as there were systemic toxicity effects especially after oral dosing). Therefore iron dichloride is a worst case source chemical, showing a factor of at least 6 in benefit of iron sulfide based on the difference in LD50 (>300 mg/kg for iron dichloride and > 200 mg/kg bw for iron sulfide). This factor will be further used for risk evaluation based on read across for threshold related endpoints.
Justification for classification or non-classification
Iron sulfide does not have to be classified for acute toxicity according the EU labelling regulations of CLP No. 1272/2008 of 16 December 2008.
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