Manganese di(acetate)

Acute Toxicity: oral

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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:

other: 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.