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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Old study (1963), limited reporting, no GLP
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Toxicite comparee de quelques ions metalliques et de leur chelate a l'acide ethylenediaminetetraacetique
Author:
Nofre C, Clement JM, Cier A
Year:
1963
Bibliographic source:
Path. Biol. 11, 853-865
Report date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Animals were dosed via the intraperitoneal route.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)
EC Number:
239-407-5
EC Name:
Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)
Cas Number:
15375-84-5
Molecular formula:
C10H12N2O8MnNa2
IUPAC Name:
Disodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; manganese(+2) cation
Details on test material:
EDTA-MnNa2 was prepared by mixing 1:1 MnSO4.H2O with EDTA-Na4

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
329.6 mg/kg bw
Based on:
element
95% CL:
>= 308.8 - <= 350.4
Remarks on result:
other: 329.6 mg/kg bw Mn corresponds to 329.6 x 389.1/55 = 2332 mg EDTA-MnNa2 per kg bw

Applicant's summary and conclusion

Conclusions:
The test material, a 1:1 mixtrure of MnSO4.H2O and EDTA-H2Na2/EDTA-Na4 was not acutely toxic via the ip route.
Executive summary:

In acute study in Swiss mice both MnSO4.H2O and a 1:1 mixture of MnSO4.H2O and EDTA-Na4 were tested via a single intraperitoneal injection. The animals were observed for 30 days. The LD50 of the 1:1 mixture (resulting in EDTA-MnNa2) turned out to be 329.6 mg Mn per kg bw corresponding to 2332 mg EDTA-MnNa2 per kg bw. On a molar basis EDTA-MnNa2 was 7.5 times less toxic than the corresponding salt MnSO4.H2O, on a mg/kg bw basis EDTA-MnNa2 was 19 times less toxic.