Registration Dossier
Registration Dossier
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EC number: 215-266-5 | CAS number: 1317-35-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of feeding manganese antiknock gasoline additive exhaust residues (manganese (III) oxide) in rats
- Author:
- Exon JH and Koller LD
- Year:
- 1 975
- Bibliographic source:
- Bulletin of Environmental Contamination, 14(3): 370-3
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 28-day repeat dose via oral route.
- GLP compliance:
- no
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200000, 20000, 2000, 200 or 0 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1750 mg/kg bw (week 1) then 7500 to 8900 mg/kg bw during weeks 2,3,4 (Group I)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
630-1220 mg/kg bw over weeks 1-4 (Group 2)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
70-110 mg/kg bw over weeks 1-4 (Group 3)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
4-13 mg/kg bw over weeks 1-4 (Group 4)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 4 males per dose group
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- -bodyweight was recorded twice weekly.
-food consumption and signs of clinical abnormalities. - Sacrifice and pathology:
- All rats were sacrificed after 28 days. Sections of tissues (lung, heart, spleen, liver, kidney, brain, adrenal gland, intestine, muscle and spinal cord) were fixed and examined microscopically for histopathological changes.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Gross pathological findings:
- no effects observed
- Details on results:
- -Food Consumption: Rats in the highest dose group consumed less than one-half as much feed as rats in other groups.
-Bodyweight gain: Rats in highest dose group steadily lost weight throughout the experiment.
-Mortality: No mortalities in any dose group.
-Clinical signs: Rats in highest dose group were emaciated, lethargic and hypersensitive to handling. After 28 days of exposure these conditions were more pronounced.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- < 9 mg/kg bw/day (nominal)
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Mn3O4 fed to rats for 28 days showed low oral toxicity, even at doses as high as 8900 mg Mn3O4/kg bw/day.
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