Registration Dossier
Registration Dossier
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EC number: 808-281-9 | CAS number: 112401-09-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Dec 2017 - 07 Feb 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 guidelineopen allclose all
- 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)
- Version / remarks:
- adopted in 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- adopted in 2017
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
Test material
- Reference substance name:
- piperidine-4-carbothioamide
- EC Number:
- 808-281-9
- Cas Number:
- 112401-09-9
- Molecular formula:
- C6H12N2S
- IUPAC Name:
- piperidine-4-carbothioamide
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 μL
- Concentration: 20% in physiological saline
VEHICLE CONTROL
- Amount applied: 750 µL
- Concentration: 0.9% (v/w)
POSITIVE CONTROL
- Amount applied: 750 µL
- Concentration: 20% in physiological saline - Duration of treatment / exposure:
- 4 h
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- Three corneae were used for each treatment group.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean value of 3 corneae
- Run / experiment:
- 4 h exposure
- Value:
- 44.963
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive according to Regulation (EC) No. 1272/2008
- Conclusions:
- The irritation potential of the test substance was assessed in the BCOP assay. Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 44.963. All validity criteria were within acceptable limits. Thus, the test substance is considered to be non-corrosive, but no prediction on the irritation potential can be made and further evaluation and/or data generation is required.
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