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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:
Sodium feredetate
EC Number:
239-802-2
EC Name:
Sodium feredetate
Cas Number:
15708-41-5
Molecular formula:
C10H12N2O8FeNa
IUPAC Name:
iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
EDTA-FeNa was prepared by mixing 1:1 Fe2(SO4)3 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:
LD50
Effect level:
21.3 mg/kg bw
Based on:
element
95% CL:
>= 20.2 - <= 22.4
Remarks on result:
other: MW EDTA-FeNa.3H2O = 421 21.3 mg/kg bw Fe corresponds to 21.3 x 421/56 = 160 mg EDTA-FeNa.3H2O per kg bw

Applicant's summary and conclusion

Conclusions:
The test material, a 1:1 mixture of Fe2(SO4)3 and EDTA-Na4 was toxic via the ip route.
Executive summary:

In acute study in Swiss mice both Fe2(SO4)3 and a 1:1 mixture of Fe2(SO4)3 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-FeNa) turned out to be 21.3 mg Fe per kg bw corresponding to 160 mg EDTA-FeNa.3H2O per kg bw. On a molar basis EDTA-FeNa.3H2O was 2 times less toxic than the corresponding salt Fe2(SO4)3, on a mg/kg bw basis EDTA-FeNa.3H2O was also 2 times less toxic.