Registration Dossier
Registration Dossier
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EC number: 200-529-9 | CAS number: 62-33-9
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted prior to GLP but sufficient data is available for the interpretation of study results together with results of inhalation studies with other metal chelates.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A limit test was carried out.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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 (as cited in study report): Calcium Disodiumethylenediaminetetraacetate dihydrate
- Molecular weight (if other than submission substance): 376
- Physical state: White crystals
- Name: Versene CA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified in the report
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Not specified in the report
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 7 h
- Concentrations:
- Nominal concentration 1.13 mg/L
- No. of animals per sex per dose:
- 4 albino rats
- Control animals:
- not specified
- Details on study design:
- The exposure of 4 albino rats to the dust atmosphere (nominal concentration 1.13 mg/L) for 7 hours
- Statistics:
- Not specified in the report
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- > 1.13 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 7 h
- Remarks on result:
- other: 100% survival
- Mortality:
- All animals survived
- Clinical signs:
- other: Not specified in the report
- Body weight:
- Not specified in the report
- Gross pathology:
- Not specified in the report
- Other findings:
- Not specified in the report
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study this test material is practically nontoxic as per EU classification when tested on albino rats via dust inhalation.
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