Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 150 mg/kg bw
Based on:
test mat.
Remarks:
Manganese sulphate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 783 mg/kg bw
Based on:
element
Remarks:
Calculated Mn based on sulphate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 470 mg/kg bw
Based on:
test mat.
Remarks:
Manganese dichloride
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.