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Toxicological information

Repeated dose toxicity: oral

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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:
1975
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

Constituent 1
Chemical structure
Reference substance name:
Trimanganese tetraoxide
EC Number:
215-266-5
EC Name:
Trimanganese tetraoxide
Cas Number:
1317-35-7
Molecular formula:
Mn3O4
IUPAC Name:
dimanganese(3+) manganese(2+) tetraoxidandiide

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.