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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study similar to guideline with deviations, documentation on raw data missing. However, the given data indicate that the study was well-performed.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA, Nycum JS
Year:
1969
Bibliographic source:
American Industrial Hygiene Association Journal, 30(5): 470 (1969)
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA
Year:
1962
Bibliographic source:
American Industrial Hygiene Association Journal 23:95 (1962)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
animals are non-fasted, certain documentation is lacking
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese di(acetate)
EC Number:
211-334-3
EC Name:
Manganese di(acetate)
Cas Number:
638-38-0
Molecular formula:
C2H4O2.1/2Mn
IUPAC Name:
manganese(2+) diacetate
Details on test material:
Manganous Acetate, Mn(OOCCH3)2*4H2O

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reared in in-house colony, Mellon Institute of Industrial Research, Pittsburgh, Pennsylvania
- Age at study initiation: 4 -5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: no
- Housing: unknown
- Diet (e.g. ad libitum): Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Gavage of solution of a concentration of 0.2 g/ml Mn(OOCH3)2*4H2O
Doses:
Arranged in a logarithmic series differing by a factor of two
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
Statistics:
The most probalbe LD50 value and its fiducial range are estimated b ythe method of Thompson (Thompson, W.R.: Use of moving averages and interpolation to estimate median effective dose. Bacteriol. Rev. 11:115 (June 1947)) using the tables of Weil (Weil, C.S.: Tables for convenient calculation of median-effective dose (LD50 or EC50) and instructions on their use. Biometrics 8:249 (Sept. 1952)).

Results and discussion

Preliminary study:
no data
Effect levels
Dose descriptor:
LD50
Effect level:
ca. 3 730 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Single oral LD50 vary from 2680-5210 mg/kg bw, expressed as Manganese Acetate Tetrahydrate
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Although there are some deficiencies in documentation, the given data indicate that the study was well-performed similar to OECD guideline 401. Therefore, the results can be considered as reliable and the LD50 value of 3.73 g/kg bw can be used for classification. Consequently, Manganese acetate can be stated to be relatively harmless.
Executive summary:

In an acute oral toxicity study, groups of non-fasted, 4 -5 weeks old Carworth-Wistar male rats (five rats / group) were given a single oral dose of Manganous acetate in water (0.2 g/ml) at doses arranged in a logarithmic series differing by a factor of two and were observed for 14 days. The oral LD50 in males was determined to be 3.73 g/kg bw . Manganese acetate is of low toxicity based on the LD50 in male Carworth-Wistar rats.