Registration Dossier
Registration Dossier
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EC number: 606-444-7 | CAS number: 20150-34-9
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
- Reference Type:
- study report
- 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:
- bis(λ⁴-iron(2+)) tetrakis(2-aminoacetate)
- EC Number:
- 606-444-7
- Cas Number:
- 20150-34-9
- Molecular formula:
- C4H8FeN2O4
- IUPAC Name:
- bis(λ⁴-iron(2+)) tetrakis(2-aminoacetate)
- Test material form:
- solid
Constituent 1
Results and discussion
In vitro
Results
- Irritation parameter:
- percent corneal swelling
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- In this ICET, IRON GLYCINATE did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. The overall ICE classes were once I (based on the corneal swelling of 4% within 240 minutes), once II (based on the fluorescein retention of 0.8) and once III (based on the corneal opacity score of 1.7).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the guideline OECD 438, IRON GLYCINATE 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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