Registration Dossier
Registration Dossier
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EC number: 945-989-8 | 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:
- 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 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-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- EC Number:
- 945-989-8
- IUPAC Name:
- Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- Test material form:
- solid: crystalline
Constituent 1
Test system
- Vehicle:
- other: corn oil
- Controls:
- yes
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% solution of the substance in corn oil
- Duration of treatment / exposure:
- 4 h ± 5 minutes at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- At the end of exposure period, the test item, positive and negative controls were removed from the anterior chamber and the corneal epithelium was washed until no visual evidence of test item was observed using EMEM (containing phenol red).
- Number of animals or in vitro replicates:
- 4 sets of 3 corneas
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- no effect was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating.
- Executive summary:
The IVIS score for the corneas treated with 750 μLreaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide (suspension) at 20% (w/v) concentration incorn oilwere found to be 0.22.
Based on the results of this study, the classification for reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide is as follows:
Classification (OECD 437 UN GHS) : No Category
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