Registration Dossier
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EC number: 941-682-8 | CAS number: 1476113-93-5
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine
- EC Number:
- 941-682-8
- Cas Number:
- 1476113-93-5
- Molecular formula:
- C13 H18 Cl N
- IUPAC Name:
- N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: COBB 500
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL - Duration of treatment / exposure:
- 10 sec
- Number of animals or in vitro replicates:
- 3 (test material and positive control), 1 (negative control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test material - mean out of 3 eyes
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- test material - mean out of 3 eyes
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 240 min
- Run / experiment:
- test material - mean out of 3 eyes
- Value:
- 1.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive and not irritant
- Conclusions:
- In this in vitro eye irritation study in the Isolated Chicken Eyes model, 30 µL of test material were applied to the chicken eyes for 10 sec. Before the treatment and 30, 75, 120, 180 and 240 min after the post-treatment rinse the eyes were observed regarding cornea opacity and cornea thickness. Fluorescein retention was measured at time point 0 and 30 min after the post-treatment rinse. Under the conditions of the test, the test material was shown to have no corrosive potential in the Isolated chicken eye (ICE) test prediction model. Based on these results and according to EU classification criteria, the test substance is not to be classified.
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