Registration Dossier
Registration Dossier
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EC number: 252-809-5 | CAS number: 35947-07-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Calcium glycinate (1:2)
- EC Number:
- 252-809-5
- EC Name:
- Calcium glycinate (1:2)
- Cas Number:
- 35947-07-0
- Molecular formula:
- (C4H10N2O5Ca)n)
- IUPAC Name:
- catena (q3-glycinato-(q2-glycinato)-aqua-calcium)
- Test material form:
- solid: crystalline
Constituent 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Mean maximum corneal opacity
- Value:
- 1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- corneal swelling
- Remarks:
- Mean maximum corneal swelling at up to 75 min
- Value:
- 11
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Mean maximum corneal swelling at up to 240 min
- Value:
- 18
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- In this ICET, CALCIUM DIGLYCINATE did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. The overall ICE classes were thrice II (based on the corneal swelling of 18% within 240 minutes, the corneal opacity score of 1.0 and fluorescein retention of 0.7).
Positive and negative controls showed the expected results. The experiment was considered to be valid.
According to the guideline OECD 438, CALCIUM DIGLYCINATE overall in vitro classification is neither UN GHS Classification Category I (an ocular corrosive or severe eye irritant) nor No Category. Thus, according to the guideline OECD 438, test item has been categorized as “No prediction can be made”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this ICET, CALCIUM DIGLYCINATE did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. The overall ICE classes were thrice II (based on the corneal swelling of 18% within 240 minutes, the corneal opacity score of 1.0 and fluorescein retention of 0.7).
Positive and negative controls showed the expected results. The experiment was considered to be valid.
According to the guideline OECD 438, CALCIUM DIGLYCINATE overall in vitro classification is neither UN GHS Classification Category I (an ocular corrosive or severe eye irritant) nor No Category. Thus, according to the guideline OECD 438, test item has been categorized as “No prediction can be made”.
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