Registration Dossier
Registration Dossier
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EC number: 282-956-0 | CAS number: 84501-38-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- In vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th to 25th september 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9th October, 2017
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- CERTIFICATE OF COMPLIANCE WITH THE PRINCIPLES OF GOOD LABORATORY PRACTICE (Legislative Decree N r . 50, March 2nd 2007 – Directive 2004/9/EC). Ministry of Health D.G. FOR HEALTH PREVENTION OFFICE I V
Test material
- Reference substance name:
- N-[2-(4,5-dihydro-2-pentadecyl-1H-imidazol-1-yl)ethyl]hexadecan-1-amide
- EC Number:
- 274-293-0
- EC Name:
- N-[2-(4,5-dihydro-2-pentadecyl-1H-imidazol-1-yl)ethyl]hexadecan-1-amide
- Cas Number:
- 70055-53-7
- Molecular formula:
- C36H71N3O
- IUPAC Name:
- N-[2-(2-pentadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]hexadecanamide
- Reference substance name:
- N,N'-(iminodiethane-2,1-diyl)bishexadecan-1-amide
- EC Number:
- 256-012-3
- EC Name:
- N,N'-(iminodiethane-2,1-diyl)bishexadecan-1-amide
- Cas Number:
- 42940-00-1
- Molecular formula:
- C36H73N3O2
- IUPAC Name:
- N,N'-(iminodiethane-2,1-diyl)dihexadecanamide
- Reference substance name:
- N,N'-ethylenedi(stearamide)
- EC Number:
- 203-755-6
- EC Name:
- N,N'-ethylenedi(stearamide)
- Cas Number:
- 110-30-5
- Molecular formula:
- C38H76N2O2
- IUPAC Name:
- N,N'-ethane-1,2-diyldioctadecanamide
- Reference substance name:
- N,N'-(iminodiethane-1,2-diyl)distearamide
- EC Number:
- 233-538-1
- EC Name:
- N,N'-(iminodiethane-1,2-diyl)distearamide
- Cas Number:
- 10220-90-3
- Molecular formula:
- C40H81N3O2
- IUPAC Name:
- N,N'-(iminodiethane-2,1-diyl)dioctadecanamide
- Reference substance name:
- N-[2-[(2-aminoethyl)amino]ethyl]hexadecan-1-amide
- EC Number:
- 255-354-0
- EC Name:
- N-[2-[(2-aminoethyl)amino]ethyl]hexadecan-1-amide
- Cas Number:
- 41413-42-7
- Molecular formula:
- C20H43N3O
- IUPAC Name:
- N-{2-[(2-aminoethyl)amino]ethyl}hexadecanamide
- Reference substance name:
- (Z)-N-[2-[(2-aminoethyl)amino]ethyl]-9-octadecenamide
- EC Number:
- 239-614-0
- EC Name:
- (Z)-N-[2-[(2-aminoethyl)amino]ethyl]-9-octadecenamide
- Cas Number:
- 15566-80-0
- Molecular formula:
- C22H45N3O
- IUPAC Name:
- N-{2-[(2-aminoethyl)amino]ethyl}octadec-9-enamide
- Reference substance name:
- N-[2-[(2-aminoethyl)amino]ethyl]stearamide
- EC Number:
- 222-690-4
- EC Name:
- N-[2-[(2-aminoethyl)amino]ethyl]stearamide
- Cas Number:
- 3574-73-0
- Molecular formula:
- C22H47N3O
- IUPAC Name:
- N-{2-[(2-aminoethyl)amino]ethyl}octadecanamide
- Reference substance name:
- N-[2-(2-heptadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]stearamide
- EC Number:
- 247-577-7
- EC Name:
- N-[2-(2-heptadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]stearamide
- Cas Number:
- 26272-76-4
- Molecular formula:
- C40H79N3O
- IUPAC Name:
- N-[2-(2-heptadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]octadecanamide
- Reference substance name:
- Acetic acid
- EC Number:
- 200-580-7
- EC Name:
- Acetic acid
- Cas Number:
- 64-19-7
- Molecular formula:
- C2H4O2
- IUPAC Name:
- acetic acid
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Reference substance name:
- Sodium nitrate
- EC Number:
- 231-554-3
- EC Name:
- Sodium nitrate
- Cas Number:
- 7631-99-4
- Molecular formula:
- HNO3.Na
- IUPAC Name:
- sodium nitrate
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- H2O4S.2Na
- IUPAC Name:
- disodium sulfate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- other: Gummy solid easily breakable, with tendency to generate scales
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % Cell viability
- Remarks:
- Measure of the cellular dehydrogenase activity
- Value:
- ca. 73.7
- Remarks on result:
- no indication of irritation
- Remarks:
- Value expressed in %. The test chemical is identified as not requiring classification and labelling according to UN GHS (No Category) as the mean percent tissue viability after exposure and post-exposure incubation is more than (>) 60%
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Conclusions:
- The substance must be considered NOT IRRITANT for eye.
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