Registration Dossier
Registration Dossier
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EC number: 271-766-3 | CAS number: 68607-67-0
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
- Justification for type of information:
- Guideline study to GLP, 2017
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Schiff bases, C11-14-tert-alkyl methylene
- EC Number:
- 271-766-3
- EC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Cas Number:
- 68607-67-0
- Molecular formula:
- C14H29N
- IUPAC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot number: HMK/370/12/1
Storage conditions: Room temperature (15 – 25°C)
Purity/Assay: Active >98%
Appearance: Straw to Yellow Clear Bright Liquid
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- ca. 20.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The positive control, ethanol, elicited an In Vitro Irritancy Score of 40.2.
The negative control, 0.9% sodium chloride solution, opacity mean change value was 1.7
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Although the result concludes that the irritancy cannot be predicted, the substance caused a degree of corneal opacity with a score of ca 20 and significantly over the limit score of 3 for non-classified.
In view of this indication of some eye irritation, classification as Eye Irrit 2 is proposed.
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