Registration Dossier
Registration Dossier
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EC number: 467-100-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 July 2017 - 18 October 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- adopted: 26 July 2013
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 467-100-8
- EC Name:
- -
- Cas Number:
- 116229-43-7
- Molecular formula:
- C15H33NO3Si
- IUPAC Name:
- (E)-(4-methylpentan-2-ylidene)[3-(triethoxysilyl)propyl]amine
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
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): 750 μL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 0.9% NaCl
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 100% EtOH - Duration of treatment / exposure:
- 10 min.
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 35.32
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
Any other information on results incl. tables
See attached file for data tables.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The mean in vitro irritation score of 35.32 falls in the range for which no prerdiction of a UN GHSS category can be made.
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