Registration Dossier
Registration Dossier
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EC number: 259-411-0 | CAS number: 54959-35-2
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- 1 963
- 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
- Reference substance name:
- Sodium feredetate
- EC Number:
- 239-802-2
- EC Name:
- Sodium feredetate
- Cas Number:
- 15708-41-5
- Molecular formula:
- C10H12N2O8FeNa
- IUPAC Name:
- Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation
- Details on test material:
- EDTA-FeNa was prepared by mixing 1:1 Fe2(SO4)3 with EDTA-Na4
Constituent 1
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.
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