Registration Dossier
Registration Dossier
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EC number: 247-019-2 | CAS number: 25481-21-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from Authoritative Database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- Chemidplus Database,U.S. National Library of Medicine,2017
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2018
- Reference Type:
- review article or handbook
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- John Wiley & Sons
- Year:
- 2 012
- Bibliographic source:
- PATTY'S INDUSTRIAL HYGIENE AND TOXICOLOGY
- Reference Type:
- review article or handbook
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- Rowe et. al.
- Year:
- 2 006
- Bibliographic source:
- Handbook of Pharmaceutical Excipients
- Reference Type:
- publication
- Title:
- Acute oral toxicity study of test chemical was performed in rats.
- Author:
- OSER et. al.
- Year:
- 1 963
- Bibliographic source:
- TOXICOLOGY AND APPLIED PHARMACOLOGY
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of test chemical was performed in rats.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
Test material
- Reference substance name:
- Sodium calcium edetate
- EC Number:
- 200-529-9
- EC Name:
- Sodium calcium edetate
- Cas Number:
- 62-33-9
- Molecular formula:
- C10H12CaN2O8.2Na
- IUPAC Name:
- calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Details on test material:
- - Name of test material (IUPAC name): calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Common name: Sodium calcium edetate
- Molecular formula: C10H12CaN2Na2O8
- Molecular weight: 376.2846 g/mol
- Smiles notation: [N]123CC(=O)[O-][Ca+2]453([N](CC1)(CC(=O)[O-]4)CC(=O)[O-]5)[O-]C(=O)C2.[Na+].[Na+]
- InChl: 1S/C10H16N2O8.Ca.2Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19)20;;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;;/q;+2;2*+1/p-4
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 50% mortality was observed at dose 10000 mg/kg bw in treated rats
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- Based on the data published it was concluded that, the lethal concentration (LD50) value for acute oral toxicity test was considered to be 10000 mg/kg bw.
- Executive summary:
Acute oral toxicity study was performed in fasted rats using test chemical. It was observed that 50% mortality was found at dose of 10000 mg/kg bw. Hence,LD50 value was considered to be 10000 mg/kg bw,when fasted rats were treated with test chemical orally. Thus as per CLP criteria it was concluded that the test chemical does not classified for acute oral toxicity.
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