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EC number: 234-685-4 | CAS number: 12023-91-5
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- comparable to guideline study with acceptable restrictions
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:
- other:
- Version / remarks:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- 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
- 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, Si
ngapore 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 - Details on 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 t
heir termination days, respectively.
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- 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 t
oxicity is not expected. No severe toxicity was expected to the test item based on the product inf
ormation 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 we
ight daily was selected for this study.
- Rationale for animal assignment (if not random): random
- Other:
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- 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).
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Not applicable - no adverse effects observed
- Remarks on result:
- not determinable
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- Other effects:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Remarks on result:
- not determinable
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- not specified
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 t
hroughout 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-pres
ent 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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