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Registration Dossier
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EC number: 208-901-2 | CAS number: 546-46-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Part 492, adopted 28. Jul. 2015 , “Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classifica-tion and Labelling for Eye Irritation or Serious Eye Damage"
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Laus GmbH
Test material
- Reference substance name:
- Trizinc dicitrate
- EC Number:
- 208-901-2
- EC Name:
- Trizinc dicitrate
- Cas Number:
- 546-46-3
- Molecular formula:
- C6H8O7.3/2Zn
- IUPAC Name:
- trizinc dicitrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- other: normal, human-derived keratinocytes
- Details on test animals or tissues and environmental conditions:
- Commercially available OCL-200-EIT / OCL-212-EIT EpiOcularTM tissue kit.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Neg. Controls: demin. H2O, pos. Controls: Methyl acetate
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50.4 mg - Duration of treatment / exposure:
- 6h
- Observation period (in vivo):
- post-treatment incubation: 18 h
- Number of animals or in vitro replicates:
- 2 Tissues (according to guideline)
- Details on study design:
- Mean optical density was measured and viability was calculated according to guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- other: %viability
- Run / experiment:
- Mean after 24 h
- Value:
- 4.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- After treatment with the test item, the relative absorbance values were reduced to 4.7 %.
This value is well below the threshold for eye irritation potential (≤ 60%). - Other effects:
- All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 1.5 (> 0.8 and < 2.5).
The positive control induced a decrease in the relative absorbance as compared to the negative control to 32.1%.
Variation within the replicates was acceptable (<20 %).
For these reasons, the result of the test is considered as valid.
Applicant's summary and conclusion
- Interpretation of results:
- other: GHS category 1 or 2
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the test system, trizinc dicitrate is considered as eye irritant in the EpiOcularTM Eye Irritation Test (OECD 492).
- Executive summary:
The test item trizinc dicitrate was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 h.
The solid test item was applied to each tissue. After treatment with the test item, the relative absorbance values were reduced to 4.7 %.
This value is well below the threshold for eye irritation potential (≤ 60%).
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