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EC number: 234-685-4 | CAS number: 12023-91-5
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-09-15 to 2010-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data generated according to generally valid testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- combined with: Official Journal of the European Union. B.2. Acute Toxicity (Inhalation) and Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Second revised edition, 2007. Chapter 3.1 Acute Toxicity
- Deviations:
- yes
- Remarks:
- Minor deviations which do not impact significantly validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dodecairon strontium nonadecaoxide
- EC Number:
- 234-685-4
- EC Name:
- Dodecairon strontium nonadecaoxide
- Cas Number:
- 12023-91-5
- Molecular formula:
- Fe12O19.Sr
- IUPAC Name:
- dodecairon(3+) strontium(2+) nonadecaoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): Strontiumhexaferrite ("Manipermpulver")
- Analytical purity: 100 % industrial strontiumferrite
- Impurities (identity and concentrations): see section 1.2 of the IUCLID5.2-file
- Composition of test material, percentage of components: see section 1.2 of the IUCLid5.2-file
- Lot/batch No.: S16/179/08
- Expiration date of the lot/batch: 12/2999
- Stability under test conditions: stable
- Storage condition of test material: air-conditioned romm temperature, non-sterile
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National University of Singapore, Centre for Animal Resources (CARE), 7 Perahu Road, Singapore 718836
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation:ca. 237285 g (female), ca. 381 - 455 g (male)
- Fasting period before study: no data
- Housing: OptiMICE Caging IVC Systems for Rats
- Diet (e.g. ad libitum): PicoLab Rodent Labdiet 20 5053, ad libitum during oberservation period, withdrawn throughout exposure period.
- Water (e.g. ad libitum): Tap water, ad libitum, through plastic bottle
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): natural conditions
IN-LIFE DATES: From: 2010-09-10 To: 2010-09-30
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:TSE Nose (head) only Inhalation Exposure System, Project No 4223
- Exposure chamber volume: no data
- Method of holding animals in test chamber: no specific holding
- Source and rate of air: Flow air: 15.00 L/min, flow application 15.00 L/min
- Method of conditioning air: positive pressure difference
- System of generating particulates: The test substance was dried at 70 °C overnight before used for dust cake generation. No other pre-treatment was conducted before administration.
- Method of particle size determination: Cascade impactor 0.5 L/min
- Treatment of exhaust air: removed
- Temperature, humidity, pressure in air chamber: 30.6 - 31.9 °C, 10.6 - 11.4 % relatrive humidity, oxygen percentage 21.02 - 21.22 %
TEST ATMOSPHERE
- Brief description of analytical method used: Measurement of actual concentration by gravimetry method through a filtration unit connected to one of the exposure port
- Samples taken from breathing zone: yes/no
VEHICLE
not applicable
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 1,70 µm MMAD (mass median aerodynamic diamter) with 2.29 GSD (geometric standrad deviation)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): see above
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: According to OECD Guideline for the testing of Chemicals 403, the limit dose is 5 mg /L or the maximum attainable concentration for solid substance (dust). The limit dose is normally used for the test substances that the toxicity or mortality is not expected. Thus, limit dose of 5 mg /L or the maximum attainable concentration of the test item was selected based on the information provided by the sponsor. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetry method through a filtration unit connected to one of the exposure port
- Duration of exposure:
- ca. 4 h
- Concentrations:
Actual maximum attainable concentration of the test substance:
Measurement 1 (mg /L) Measurement 2 (mg / L) Measurement 3 (mg / L) Average (mg/L)
0.55 0.62 0.66 0.61- No. of animals per sex per dose:
- 10 (5 male, 5 female)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: after 1 d, 3 d, 7 d and 14 d
- Frequency of observations and weighing: see above
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: body weight, observations
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- > 0.61 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality
- Clinical signs:
- other: No adverse effect was observed throughout the observation period.
- Body weight:
- no adverse effects.
- Gross pathology:
- No necropsy findings related to the test substance strontium ferrite
Any other information on results incl. tables
Body weight (bw, in gram) and body weight changes (change, in gram) of each animal during observation period
Group No |
Animal ID |
16-Sep-2010 Dosing day (Day 0) |
17-Sep-2010 (Day 1) |
19-Sep-2010 (Day 3) |
23-Sep-2010 (Day 7) |
30-Sep-2010 (Endpoint Day) |
||||
Bw |
Change |
Bw |
Change |
Bw |
Change |
Bw |
Change |
|||
Female |
219103186-12-00- F1 |
264.8 |
268.2 |
+3.4 |
258.5 |
-9.7 |
261.9 |
+3.4 |
264.6 |
+2.7 |
219103186-12-00- F2 |
273.3 |
283.4 |
+10.1 |
277.6 |
-5.8 |
285.0 |
+7.4 |
287.6 |
+2.6 |
|
219103186-12-00- F3 |
278.4 |
290.6 |
+12.2 |
280.7 |
-9.9 |
292.2 |
+11.5 |
294.9 |
+2.7 |
|
219103186-12-00- F4 |
236.7 |
239.0 |
+2.3 |
237.6 |
-1.4 |
244.6 |
+7.0 |
242.4 |
-2.2 |
|
219103186-12-00- F5 |
284.5 |
297.2 |
+12.7 |
284.0 |
-13.2 |
293.0 |
+9.0 |
309.6 |
+16.6 |
Group No |
Animal ID |
16-Sep-2010 Dosing day (Day 0) |
17-Sep-2010 (Day 1) |
19-Sep-2010 (Day 3) |
23-Sep-2010 (Day 7) |
30-Sep-2010 (Endpoint Day) |
||||
Bw |
Change |
Bw |
Change |
Bw |
Change |
Bw |
Change |
|||
Male |
219103186-12-00- M1 |
446.1 |
477.2 |
+31.1 |
473.9 |
-3.3 |
486.5 |
+12.6 |
520.0 |
+33.5 |
219103186-12-00- M2 |
430.8 |
451.2 |
+20.4 |
450.8 |
-0.4 |
464.4 |
+13.6 |
493.8 |
+29.4 |
|
219103186-12-00- M3 |
380.8 |
403.6 |
+22.8 |
403.8 |
-0.2 |
419.3 |
+15.5 |
450.0 |
+30.7 |
|
219103186-12-00- M4 |
414.4 |
422.3 |
+7.9 |
433.0 |
+10.7 |
439.3 |
+6.3 |
488.1 |
+48.8 |
|
219103186-12-00- M5 |
455.4 |
474.4 |
+19.0 |
462.7 |
-11.7 |
473.6 |
+10.9 |
480.0 |
+6.4 |
Gross necropsy was conducted on all the animals on the termination day. The necropsy finding and evaluation on all the animals were as follows:
Group No |
Animal ID |
Necropsy finding |
Evaluation |
Female |
219103186-12-00- F1 |
No necropsy finding |
Nil |
219103186-12-00- F2 |
Scattered patchy area in dark-red color in left lobe of lung. Texture of lung tissue looks rough |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- F3 |
Patchy area in dark-red color in lower part of left lobe of lung. Lymph node 1 x 3 mm under the right lobe of thymus adjacent to trachea |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- F4 |
Lymph node 1 x 2.5 mm under right lobe of thymus. Patchy area in dark-red color in right cranial lobe of lung |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- F5 |
No necropsy finding |
Nil |
Group No |
Animal ID |
Necropsy finding |
Evaluation |
Male |
219103186-12-00- M1 |
No necropsy finding |
Nil |
219103186-12-00- M2 |
Black spots with about 0.5-1 mm in diameter on the surface of each lobe of lung. Lymph node 1 x 3 mm under the right lobe of thymus adjacent to trachea |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- M3 |
Scattered patchy area in dark-red color in right caudal lobe and left lobe. Lymph nodes 1 x 2.5 mm under right lobe of thymus and 1.5 x 1.5 mm adjacent to left lobe of thymus |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- M4 |
Two black spots with 0.5-1 mm in diameter on the left lobe of lung. |
The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance |
|
219103186-12-00- M5 |
No necropsy finding |
Nil |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Strontium ferrite did not show any inhaltive toxicity when being administered with the limit dose of 5 mg/L (resulting in an average attainable concentration of 0.61 mg/L) according to OECD Guideline 403. No higher test concentrationw as achievable due to the substance properties.
a) No animal died during the 14-day observation period
b) No adverse effects were observed on the animals throughout the observation period
c) The necropsy finding was observed at the endpoint day and considered to be caused by carbon dioxide euthanization but not administration of test substance.
Hence, exposing the test item to rats for 4 hours using TSE Nose (head) only Exposure System, no acute inhalation toxicity was observed at the maximum attainable concentration of 0.61 mg/L.
Based on the above results strontium ferrite did not show acute inhalation toxicity at the maximum attainable concentration of 0.61 mg/L. - Executive summary:
The acute inhalation toxicity of strontium ferrite was assessed in a limit test according to OECD 403 and UN-GHS. The technically achievable maximum concentration of 5 mg/L resulted in an actual average concentration of 0.61 mg/L which was apllied to Sprague Dawley rats. The exposure period was 4 hours followed by an observation period of 14 days. No mortalities or other adverse effects were observed.
Based on the above results strontium ferrite did not show acute inhalation toxicity at the maximum attainable concentration of 0.61 mg/L. Strontium ferrite showed to be non-toxic via the inhalative route in this test.
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