Registration Dossier
Registration Dossier
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EC number: 205-287-8 | CAS number: 137-29-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 May 2018- 30 May 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- SOP LOO69 @EpiOcular Eye Irritation test Using XcellR8 form FOO68
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- Batch number 37160906202
Constituent 1
Test animals / tissue source
- Species:
- other: Reconstructed Human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- The EpiOcular tissue model (OCL-200-MatTek corporation) is composed of stratified human keratinocytes in a three dimensional structure, reflecting the morphology and funcion of the human corneal epithelium found in vivo.
On the day f receipt, pre-incubation of EpiOcular tissues overnight at 37C 5%CO2 >=95% relative ,humidity.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg
- Duration of treatment / exposure:
- 6 hours+/-15 minutes
- Duration of post- treatment incubation (in vitro):
- 25+/-2 minute post treatment immersion, and 18 hours +/-15 minutes post treatment incubation
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Optical density
- Run / experiment:
- Optical density
- Value:
- ca. 2.219
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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