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EC number: 273-729-7 | CAS number: 69012-29-9 By-product from the production of ferronickel from a complex ore. Consists primarily of oxides of aluminum, iron, magnesium and silicon.
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was performed before EU/OECD protocol establishment and no guideline is mentioned. Data on reproductive and developmental toxicity for slags, ferronickel-manufg. is not available for the whole substance. Until a relevant study is performed on slags, ferronickel-manufg., it was attempted to identify possible adverse effects based on data for its recognised constituents, even though the results cannot be applied directly, due to the way the constituents are bound in the matrix of the substance and are not as bioavailable as the free substances that are examined. So, the results must be taken into consideration with care.
Data source
Reference
- Reference Type:
- publication
- Title:
- Potential toxicity of iron overload in successive generations of rats
- Author:
- R.O. Fisch,M.D., A.S. Deinard, M.D., L.J. Disch, B.A., and W. Krivit
- Year:
- 1 975
- Bibliographic source:
- The American Journal of Clinical Nutrition 28: 136-139
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline mentioned in the study
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Iron
- EC Number:
- 231-096-4
- EC Name:
- Iron
- Cas Number:
- 7439-89-6
- Molecular formula:
- Fe
- IUPAC Name:
- iron
- Details on test material:
- parenteral iron (Imferon 20 mg/kg)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Six week old Sprague-Dawley rats, fed on Purina Chow.
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- not specified
- Details on exposure:
- The experimental 16 females were given parenteral iron (Imferon: 20 mg/kg) by intramuscular injection according to the following schedule:
7 & 8-week old: 1 injection of 20mg/kg per week
9 &10-week old: 2 injections of 20mg/kg per week
11 & 12-week old: 3 injections of 20mg/kg per week
The total amount of iron given was approximately 62-72 mg/animal during the 6-week period of injections. Following the last injection at 1 2 weeks of age, the treated females received no iron for 1 week, following which they and the control females were allowed to mate with the males. During pregnancy, no female received iron injections. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not applicable
- Details on mating procedure:
- After the last injection on the females were 12 weeks old, followed 1 week without iron supplementation and then they were allowed to mate with the males. When the offspring was 6 weeks old random separation and repetition of the experiment until fourth generation was performed. Interbreeding was carefully avoided.
- Duration of treatment / exposure:
- 7 & 8-week old: 1 injection of 20mg/kg per week
9 &10-week old: 2 injections of 20mg/kg per week
11 & 12-week old: 3 injections of 20mg/kg per week - Frequency of treatment:
- 7 & 8-week old: 1 injection of 20mg/kg per week
9 &10-week old: 2 injections of 20mg/kg per week
11 & 12-week old: 3 injections of 20mg/kg per week - Duration of test:
- 6-week period of injections, until the animals were 12 weeks of age.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
between 62 and 72 mg/animal during the 6-week injection period
Basis:
actual ingested
- No. of animals per sex per dose:
- 16 animals in the first generation (G-1)
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- After the last group of females (G-4) delivered their offspring (G-5), every other female and all of her offspring were sacrificed within 12 hours of birth (Fig. 1). In all, eight treated females and their 72 offspring, as well as four control females and their 49 offspring, were sacrificed. This occurred, in general, immediately after birth and always by 12 hours of age. The sacrificed animals were assayed for total body iron content. Seven experimental females and their 62 offspring, as well as two control females and their 1 3 offspring, were allowed to live to 6 weeks of age (one female died during labor), at which time both females and offspring were weighed.
Examinations
- Maternal examinations:
- Iron assay performed in triplicate on each adult rat that was sacrificed.
Growth, as measured by weight, was also examined. - Ovaries and uterine content:
- no data
- Fetal examinations:
- Iron assay. The cadaver of each newborn rat was sectioned and dried at 110 C overnight. The dried tissue was weighed and digested in 3 ml of distilled water and 10 ml of concentrated nitric acid (redistilled by C. F. Smith Chemical Co., Columbus, Ohio). The resulting solution was gently boiled until clear and allowed to cool. The solid lipid layer that formed was removed by filtration through iron-free glass wool. Additional concentrated
nitric acid was used to rinse the lipid solids and bring the total sample volume to 25 ml. A 2-ml aliquot of the “whole-rat” solution and 10 ml of concentrated nitric acid were further digested by boiling to one-third original volume. At this point, another 10 ml of concentrated nitric acid were added and the solution was redigested. The remaining liquid was made up to a volume of 10 ml with concentrated nitric acid and its iron concentration was determined on an atomic absorption spectrophotometer using a Fischer iron standard (1-7 ppm) and concentrated nitric acid as a blank. - Statistics:
- The test of the reproducibility of iron determination was done on three different days on the offspring animals. The mean coefficient of variance (CV = 100SD/’X) was 6.6%. When this assay method was applied to situations where known concentrations of iron were present, the average percent recovery of iron was 85%.
- Indices:
- litter size (viability of offspring)
litter weight
litter iron body burden
litter rate of growth - Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No toxic effects observed.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- > 62 - < 72 other: mg/animal
- Based on:
- element
- Remarks:
- iron
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No such effects observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No differences in litter size (viability of offspring). No differences in litter weight. No differences in litter iron body burden. No differences in litter rate of growth
Applicant's summary and conclusion
- Conclusions:
- The toxicity of iron overload on successive generations was tested in female rats from generation 1 to generation 5 included. Test group received a total amount of 62-72 mg/animal during a 6 week period of dosing parenterally. This route was chosen because iron given orally is absorbed in limited quantities. When the offspring was 6 weeks old random separation and repetition of the experiment until fourth generation was performed. Mothers and offspring were examined for iron body burden, litter size and litter postnatal development. No differences in litter size (viability of offspring), litter weight, litter iron body burden and litter rate of growth was noted. It can be concluded that iron overload did not affect embryo rat development in subsequent generations.
- Executive summary:
The toxicity of iron overload on successive generations was tested in female rats from generation 1 to generation 5 included. Test group received a total amount of 62-72 mg/animal during a 6 week period of dosing parenterally. This route was chosen because iron given orally is absorbed in limited quantities. When the offspring was 6 weeks old random separation and repetition of the experiment until fourth generation was performed. Mothers and offspring were examined for iron body burden, litter size and litter postnatal development. No differences in litter size (viability of offspring), litter weight, litter iron body burden and litter rate of growth was noted. It can be concluded that iron overload did not affect embryo rat development in subsequent generations
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