Registration Dossier
Registration Dossier
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EC number: 945-990-3 | 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:
- Jan to July 2018
- Reliability:
- 1 (reliable without restriction)
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 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Condensation products of N-(6-aminohexyl)-12-hydroxyoctadecanamide and sebacic acid
- EC Number:
- 945-990-3
- IUPAC Name:
- Condensation products of N-(6-aminohexyl)-12-hydroxyoctadecanamide and sebacic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test system
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL of the prepared test item [20% (w/v) concentration in corn oil],positive control [750 μL of 20% (w/v) concentration in normal saline], two set of corneas served as negative control and was treated with 750 μL of normal saline and corn oil,
- Duration of treatment / exposure:
- 4 h ± 5 minutes at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 4 h ± 5 minutes at 32 ± 1 °C
- Number of animals or in vitro replicates:
- 3 corneas per test group. 12 in total
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- > -0.05 - < 0.19
- 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
- Conclusions:
- The substance is not irritatiing.
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