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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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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:
1976
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

Constituent 1
Chemical structure
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

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.