Registration Dossier

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:
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.