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Diss Factsheets
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EC number: 215-266-5 | CAS number: 1317-35-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A well documented study with a clearly defined scope and with sufficiently detailed materials and methods. However, there is no statement on impurity profile of the test material.
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the male reproductive system in the preweanling rat following Mn3O4 exposure
- Author:
- Laskey JW, Rehnberg GL, Hein JF, Laws SC & Edens FW
- Year:
- 1 985
- Bibliographic source:
- Journal of Toxicology and Environmental Health, 15: 339-350
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Long-Evans rat pups were dosed orally from birth to 21 days with particulate Mn3O4 at 0, 71 or 214 mg Mn/kg body weight/day. Hypothalamic, pituitary or testicular functions were determined by measuring the endogenous or stimulated serum concentration of follicle-stimulating hormone, luteinising hormone, and/or testosterone at 21 or 28 days of age were assessed. Body, testes, and seminal vesicles weight and tissue concentrations of Mn were also evaluated.
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- Trimanganese tetraoxide
- EC Number:
- 215-266-5
- EC Name:
- Trimanganese tetraoxide
- Cas Number:
- 1317-35-7
- Molecular formula:
- Mn3O4
- IUPAC Name:
- trimanganese tetraoxide
- Details on test material:
- - Name of test material : Particulate Mn3O4
- Analytical purity: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Blue Spruce Farms, Altmont, NY, USA
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 50 % sucrose solution
- Details on exposure:
- DOSE ADMINISTRATION
Animals were dosed at the rate of 1 µL/g body weight. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Animals were dosed once a day from day 1 to day 21 in both studies.
- Frequency of treatment:
- Animals were dosed daily
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 71 other: µg Mn/g bodyweight
- Remarks:
- Nominal conc. (Study 1)
- Dose / conc.:
- 71 other: µg Mn/g body weights
- Remarks:
- Nominal conc. (Study 2)
- Dose / conc.:
- 214 other: µg Mn/g body weights
- Remarks:
- Nominal conc. (Study 2)
- No. of animals per sex per dose:
- Not reported
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Pregnant rats were received on day 1 of gestation. On day 1 postpartum litters were normalised to 8 pups/litter with at least 1 female per litter.
- Statistics:
- Data were analysed, where appropriate, by one- or two-way analysis of variance, linear regression, or Duncan's multiple comparison procedures.
Results and discussion
Any other information on results incl. tables
Study 1
No Mn-treatment-related effects were seen in bodyweights at 21 of 28 days of age. There was significant depression in testes weight at 21 days in animals receiving 71 µg Mn/g bodyweight, but this difference was not present at day 28. Mn concentrations in the liver and hypothalamus were 150 and 63% higher in the Mn-treated castrated rats when compared to the Mn-treated non-castrated rats.
No Mn-treatment-related effects were seen in the endogenous T, FSH, or LH serum concentrations. No treatment effects were seen in the serum FSH or LH concentrations following castration, in the serum FSH or T concentrations following 2 -hour LH-RH stimulation, or in the 2 -hour hCG-stimulated serum T concentration. Following 7 days of hCG stimulation, however, serum T concentration was significantly lower in the Mn-treated animals. Additionally, the 7 -day hCG treatment resulted in significant and comparable increases in body, testes, and seminal vesicles weight.
Study 2
Significant Mn dose-related depressions in bodyweight were noted at 28 days of age. Testicular growth in animals that received 7 days of hCG stimulation following 214 µg Mn/g bodyweight for 21 days was less that either control animals or animals that received 71 µg Mn/g bodyweight. Mn treatment (214 µg Mn/g bodyweight) resulted in depressed serum T concentration in animals following 7 days hCG stimulation. Neither FSH nor LH serum concentrations showed any Mn-treatment-related differences with any of the assessment procedures.
Applicant's summary and conclusion
- Conclusions:
- Excess oral exposure of test material, to the preweanling rat was found to cause subtle alterations in the reproductive axis and appeared to interfere with the synthesis of T. These effects are not thought to interfere with rodent fertility at chronic dietary levels up to 1100 ppm Mn.
- Executive summary:
Rats were dosed orally from birth to 21 days with test material at 0, 71 or 214 µg Mn/g body weight/day. Hypothalamic, pituitary or testicular functions were determined by measuring the endogenous or stimulated serum concentration of follicle-stimulating hormone, luteinising hormone, and/or testosterone at 21 or 28 days of age were assessed. Body, testes, and seminal vesicles weight and tissue concentrations of Mn were also evaluated.
Only slight Mn treatment effects were seen in body and testes weights. No effects were seen either on unstimulated or stimulated FSH or LH serum concentrations. Although no Mn treatment effects were seen on endogenous or 2 hour human chorionic gonadotropin (hCG) stimulate serum T concentrations, there was a reduction in the serum T following 7 days of hCG stimulation. The hypothalamic Mn concentrations in animals with these reproductive effects were three times those where alterations in the dopaminergic pathway have been reported. However, no indication of hypothalamic or pituitary malfunction was found. These results suggest that the site of Mn damage that causes depression of sustained serum T concentrations is in the testicular Leydig cell.
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