[No public or meaningful name is available]

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Source data for read-across
The acute toxicity is considered to be linked to the dissolved Manganese ions
Manganese sulphate is considered a reliable source of data to consider potential toxicity of soluble manganese ions
Results for Chloride and Sulphate are presented to demonstrate importance of Mn ions in toxicity
Data is cited in various review documents and considered reliable
Further animal testing is not justified.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Study involved assessing a number of different metal salts
Results for Chloride and Sulphate are presented to demonstrate importance of Mn ions in toxicity
Animal behaviour assessed

GLP compliance:

no

Remarks:

Pre-dates CLP in India

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Manganese sulphate

EC Number:

232-089-9

EC Name:

Manganese sulphate

Cas Number:

7785-87-7

Molecular formula:

MnO4S

IUPAC Name:

Manganese sulphate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Actual dose levels are not reported, but were sufficient to allow estimation of LD50

No. of animals per sex per dose:

Not specified

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 100 mg/kg bw

Based on:

test mat.

Remarks:

Calculated Mn Glycinate based on Mn SO4

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 150 mg/kg bw

Based on:

test mat.

Remarks:

Manganese sulphate

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 783 mg/kg bw

Based on:

element

Remarks:

Calculated Mn based on sulphate

Effect levels 4

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 470 mg/kg bw

Based on:

test mat.

Remarks:

Manganese dichloride

Effect levels 5

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 647 mg/kg bw

Based on:

element

Remarks:

Calculated for Mn ions from chloride

Mortality:

Yes

Clinical signs:

other:

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

In view of dissociation of Mn Glycinate to Mn, Sulphate and Glycine, it is considered valid to estimate acute toxicity based on the dissociated ions.
The Manganese is considered to be the main ion impacting on acute toxicity
No further animal testing can be justified.