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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Old studies showed that EDTA-CaNa2 is not irritating to skin and slightly irritating to eyes. These results were confirmed by other in vivo / in vitro skin and eye irritation studies with other metal EDTA chelates.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted prior to GLP and limited information is available for the interpretation of study results; however, together with results of skin irritation studies with other metal chelates sufficient ifnormation is available for interpretation.
Qualifier:
according to guideline
Guideline:
other: CFR, Title 49, Section 173.240
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
Not specified in the report
Duration of treatment / exposure:
4 hr
Observation period:
Not specified in the report
Number of animals:
Not specified in the report
Details on study design:
Not specified in the report
Irritant / corrosive response data:
Not specified in the report
Other effects:
Not specified in the report
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As per EU classification calcium disodium is not irritating to skin when tested on rabbit.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted prior to GLP and limited information is available for the interpretation of study results; however, together with results of eye irritation studies with other metal chelates sufficient ifnormation is available for interpretation.
Qualifier:
no guideline available
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified in the report
Vehicle:
other: Unchanged diluted with water
Controls:
no
Amount / concentration applied:
100 % - Unwashed
100 % - Washed with water
10 % - in water - Unwashed
10 % in water - Washed with water
Duration of treatment / exposure:
Not specified in the report
Observation period (in vivo):
Not specified in the report
Number of animals or in vitro replicates:
Not specified in the report
Details on study design:
Not specified in the report
Irritant / corrosive response data:
100 % - Unwashed : Moderate pain, slight conjuntival irritation, almost completely healed in 48 hrs.
100 % - Washed with water : Trace of pain, slight conjuntival irritation, almost completely healed in 2 days.
10 % - in water - Unwashed : Trace of pain, trace of conjuntival irritation, completely healed in 24 hrs.
10 % in water - Washed with water : Trace of pain, trace of conjuntival irritation, completely healed in 24 hrs.
Other effects:
Not specified in the report
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study this test material is slightly irritating to eyes according to EU classification.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
This study was conducted prior to GLP and limited information is available for the interpretation of study results; however, together with results of skin irritation studies with other metal chelates sufficient ifnormation is available for interpretation.

Justification for selection of eye irritation endpoint:
This study was conducted prior to GLP and limited information is available for the interpretation of study results; however, together with results of eye irritation studies with other metal chelates sufficient ifnormation is available for interpretation.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the absence of skin irritation and presence of slight eye irritation only, no classifcation is needed for skin and eye irritation.