Registration Dossier

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:
manganese(2+) ion disodium 2-({2-[bis(carboxylatomethyl)amino]ethyl}(carboxylatomethyl)amino)acetate
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.