Registration Dossier
Registration Dossier
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EC number: 814-345-7 | CAS number: 2003244-43-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted on 01 April 2016.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile
- EC Number:
- 814-345-7
- Cas Number:
- 2003244-43-5
- Molecular formula:
- C14H21N
- IUPAC Name:
- 3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile
- Details on test material:
- - Name of test material (as cited in study report): ES421 Pinyl Nitrile- Molecular weight (if other than submission substance): 203 g/mol- Physical state: Crystallized white powder- Analytical purity: 98.08% (per Certificate of Analysis)- Composition of test material, percentage of components: 2-Norpinene-2-propionitrile, alpha, alpha,6,6-tetramethyl- Purity test date: 08 February 2016- Lot/batch No.: SM15077102- Storage condition of test material: 2-8°C, protected from light
1
Test animals / tissue source
- Species:
- other: Eyes from adult cattle (typically 12 to 60 months old)
- Strain:
- other: Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- Exposure period: 32 ± 1 ºC for 10 minutes.
- Duration of post- treatment incubation (in vitro):
- At 32 ± 1 ºC for 120 minutes
- Number of animals or in vitro replicates:
- Not applicable
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No category. Not requiring classification to UN GHS or EU CLP.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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