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EC number: 200-529-9 | CAS number: 62-33-9
Endpoint summary
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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
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