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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-07-26 to 2010-10-22
- 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 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- Minor deviations which do not significantly impact the validity of the study
- GLP compliance:
- yes (incl. QA statement)
- 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: (P) x wks: 7 - 9
- Weight at study initiation: (P) Males: 314-374 g; Females: 209 -271 g
- Fasting period before study: no data
- Housing: OptimMIICE Caging IVC Systems for Rats
- Use of restrainers for preventing ingestion (if dermal): not applicable
- Diet (e.g. ad libitum): PicoLab Rodent Diet 20 5053 at libitum
- Water (e.g. ad libitum): Tap water ad libitum through plastic bottle
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °c
- Humidity (%): 30 - 70 5
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The limit dose of 1000 mg/kg b.w. daily was selected. Dosing was via food and in water.
DIET PREPARATION
no data
VEHICLE
not applicable - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Dosing of both sexes began 2 weeks prior to mating, and was kept during the 14-day mating period. Dosing of Males was terminated when 14-day mating period was completed (28 days in total), while dosing of females was continued throughout the study until day 4 post-partum.
- Frequency of treatment:
- The dose was given to the parental males and females daily, seven days per week continuously until their termination days, respectively.
- Details on study schedule:
- - Age at mating of the mated animals in the study: 8 - 10 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
300 mg/ml, suspended
Basis:
nominal in water
The dose level of 1000 mg/kg b.w. was administered in the concnetration of 300 mg/l in water
- No. of animals per sex per dose:
- 12 male, 12 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: According to OECD Guideline for the testing of Chemicals 421, the limit dose is normally used for the test substances that do not produce observable toxic effects and if toxicity is not expected. No severe toxicity was expected to the test item based on the product information provided by the sponsor. In addition, the LD50 cut-off value of the test item in acute oral toxicity study was more than 5000 mg/kg body. Therefore, the limit dose of 1000 mg/kg body weight daily was selected for this study.
- Rationale for animal assignment (if not random): random
- Other: - Positive control:
- 12 male, 12 female
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once a day thoughout dosing (1 week) and observation period (22 d)
- Cage side observations checked in table: Yes. Not included in IUCLID5.2-file
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: no
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Daily
OTHER: - Oestrous cyclicity (parental animals):
- Observed and included in test study if exceptional
- Sperm parameters (parental animals):
- Parameters examined in [all/P/F1/F2] male parental generations: none
testsis weight determined after 28 d (endpoint day) - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 18 pups/litter, of which 17 alive (1 post-implantation loss)
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number and sex of pups, stillbirths, live births, runts, postnatal mortality, presence of gross anomalies, weight gain, visual abnormalities
GROSS EXAMINATION OF DEAD PUPS: yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals, as soon as possible after the last litters in each generation were produced.
- Maternal animals: All surviving animals, as soon as possible.
GROSS NECROPSY
- Gross necropsy consisted ofmacroscopic findings
HISTOPATHOLOGY / ORGAN WEIGHTS
Male: weight of testis, weight of epididymis, microscopic histological examination of testis and epididymis.
Fenale: Microscopic histological examination of ovaries - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows: Necropsy findings
GROSS NECROPSY
- Gross necropsy consisted of body weight, organ weight
HISTOPATHOLOGY / ORGAN WEIGTHS
Macroscopic findings - Statistics:
- Not described in detail
- Reproductive indices:
- gestation lenght, number of implantation
- Offspring viability indices:
- Live births, post-implanttaion loss, litter size on day 4-post partum, number of abnormal pups, numbere of runts
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
- Description (incidence and severity):
- Test substance intake: Strontium ferrite does not accumulate in the body (blood).
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- Weight of testis, epididymis and ovaries
- Reproductive performance:
- no effects observed
Details on results (P0)
Toxic response (including fertility, gestation) of parent animals and reversal: No adverse effect was observed on all the parent animals of both test and control groups throughout the observation period.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Not applicable - no adverse effects observed
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not determinable
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- not determinable
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not determinable
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No adverse effects were observed.
Applicant's summary and conclusion
- Conclusions:
- Based on the above study,
a) No parent animal died during the dosing and observation period
b) No adverse effect was observed on all the parent animals of both test and control groups throughout the observation period
c) No toxic effect was observed on reproduction of parent animals, offspring and post-natal growth of pups
d) No treatment-related necropsy finding was observed on the parent animals
e) No treatment-related microscopic finding was observed on the ovaries, testes and epididymides of the parent animals in both test and control groups. All findings observed were considered to re-present normal background changes in animals of this strain and age.
Hence, based on the above results, administrating the test item repeatedly at 1000 mg/kg body weight through oral route (28-day for male parents and up to post-partum Day 4 for female parents), the test item does not produce reproductive / developmental toxicity to Sprague Dawley (SD) rats. - Executive summary:
The reproductive / developmental toxicity of strontium ferrite was investigated in a screening study according to OECD guideline 421. The limit doese of 1000 mg/kg b.w. was administered to 12 male and 12 female rats (Spargue Dawley). The control group consisted of 12 animals each. Clinical observations were made for each animal of F1, toxic effects on reproducation, offspring and post-natal growth were examined.
Based on the study,
a) No parent animal died during the dosing and observation period
b) No adverse effect was observed on all the parent animals of both test and control groups throughout the observation period
c) No toxic effect was observed on reproduction of parent animals, offspring and post-natal growth of pups
d) No treatment-related necropsy finding was observed on the parent animals
e) No treatment-related microscopic finding was observed on the ovaries, testes and epididymides of the parent animals in both test and control groups. All findings observed were considered to re-present normal background changes in animals of this strain and age.
Hence, based on the above results, administrating the test item repeatedly at 1000 mg/kg body weight through oral route (28-day for male parents and up to post-partum Day 4 for female parents), the test item does not produce reproductive / developmental toxicity to Sprague Dawley (SD) rats.
It can be concluded that strontium ferrite does not produce reproductive / developmental toxicity.
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