Registration Dossier
Registration Dossier
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EC number: 695-268-4 | CAS number: 571188-59-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 2017 - Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability 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:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Cas Number:
- 571188-59-5
- Molecular formula:
- C14H22N4O2
- IUPAC Name:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- other: The Bovine Corneal Opacity and Permeability Assay (BCOP)
- Details on test animals or tissues and environmental conditions:
- The Bovine Corneal Opacity and Permeability Assay (BCOP)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- LEE011-A2 was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered (304.5 to 316.6 mg).
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 240 minutes at 32 °C.
- Duration of post- treatment incubation (in vitro):
- Corneas were incubated in a horizontal position for 240 minutes at 32 °C.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- opacity values
- Value:
- >= 56 - <= 115
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- negative controls ranged from -1.2 to 0.8
- Positive controls validity:
- valid
- Remarks:
- positive control ranged from 156 to 170
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In conclusion, since LEE011-A2 induced an IVIS ≥ 55, it is concluded that LEE011-A2 induces serious eye damage in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report and should be classified category 1 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
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