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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Apr. 2010 - 22 Apr. 2010
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Minor deviations not impacting vailiduity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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 room temperature, non-sterile
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
Species Rats
Strain Wistar
Microbiological status Specific Pathogen Free (SPF)
Age 6 to 8 weeks old
Sex Male, body weight 290g to 390g
Female, body weight 180g to 230g
Number Male, 5
Female, 5
Source
National University of Singapore
Centre for Animal Resources (CARE)
7 Perahu Road
Singapore 718836
Housing Condition OptiMICE Caging Systems for rats
Temperature 18 - 22oC
Humidity 30 - 70%
Food Harlan Teklad T2018 Global Rodent Diet
Water Tap water
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was moistened with water for injection .
- Details on dermal exposure:
- The test animals were acclimatised for at least 5 days before the test was conducted.
Approximately 24 hours before the test, fur in the dorsal area of each animal’s trunk was shaved. The shaved area was not less than 10 percent of the body surface.
On the dosing day, the animals were weighed prior to dosing. The test substance was administered by topical application on the shaved area of each animal. The dose level was 2000 mg/kg based on the body weight of each animal.
The test item was moistened with water for injection and applied uniformly over the shaved area which was approximately 10 percent of the total surface area. The test item was then held in contact with the skin using a gauze patch and occlusive dressing. The exposure was conducted for 24 h.
At the end of exposure period, residual test item was removed and cleaned carefully with water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw based on weight of the test item
- No. of animals per sex per dose:
- 5 female and male each.
- Control animals:
- no
- Details on study design:
- The observation of adverse effects was conducted on each animal during the first 30 minutes, periodically during the first 24 hours (with special attention during the first 4 hours), and periodically thereafter, up to 14 days. The body weight of each animal was measured every 3 to 7 days.
On the termination day, all the test animals were euthanized by CO2 inhalation. Gross necropsy was conducted on all the test animal.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during dosing and observation period.
- Clinical signs:
- other: No adverse effect was observed in all animals during dosing and observation period.
- Gross pathology:
- Necropsy was conducted on all the test animals on the termination day. No abnormality was observed on all the test animals.
- Other findings:
- Not applicable
Any other information on results incl. tables
Dose level of each test animal and adverse effects
Group No |
Animal ID |
Body weight (g) |
Amount of test item used for dosing (g) |
Dose level (based on weight of the test item, mg/kg) by body weight |
Adverse effects during and after dosing till endpoint date |
Female |
219103186-08-00-F1 |
223.8 |
0.45 |
2000 |
No adverse effects observed |
219103186-08-00-F2 |
216.6 |
0.43 |
2000 |
No adverse effects observed |
|
219103186-08-00-F3 |
226.7 |
0.45 |
2000 |
No adverse effects observed |
|
219103186-08-00-F4 |
199.7 |
0.40 |
2000 |
No adverse effects observed |
|
219103186-08-00-F5 |
188.8 |
0.38 |
2000 |
No adverse effects observed |
Group No |
Animal ID |
Body weight (g) |
Amount of test item used for dosing (g) |
Dose level (based on weight of the test item, mg/kg) by body weight |
Adverse effects during and after dosing till endpoint date |
Male |
219103186-08-00-M1 |
321.1 |
0.64 |
2000 |
No adverse effects observed |
219103186-08-00-M2 |
332.2 |
0.66 |
2000 |
No adverse effects observed |
|
219103186-08-00-M3 |
382.9 |
0.77 |
2000 |
No adverse effects observed |
|
219103186-08-00-M4 |
294.2 |
0.59 |
2000 |
No adverse effects observed |
|
219103186-08-00-M5 |
313.3 |
0.63 |
2000 |
No adverse effects observed |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After an application period of 14 days followed by an observation period of 14 days, no mortality and other adverse effects were observed. Strontium ferrite is non-toxic via the dermal route according to CLP.
- Executive summary:
The acute dermal toxicity of strontium ferrite was assessed in a limit test according to OECD 402 and UN-GHS. 2000 mg/kg bw of the test item was applied on the skin of Wistar-rats. The exposure period was 24 hours followed by an observation period of 14 days. No mortalities or other adverse effects were observed. It can therefore be concluded that the dermal LD50 is above the tested concentration of 2000 mg/kg bw.
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