Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 913-660-8 | 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:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- EpiOcular MTT Viability Assay
Draize correlation - Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Molecular formula:
- C21 H50 N O C23 H54 N O C25 H58 N O C27 H62 N O
- IUPAC Name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Test material form:
- solid: flakes
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- MatTek EpiOcular tissues Lot 8704 kit Q received on 10/03/06. Following a one hour equilibration of the tissues in the incubator (37C, 5% CO2) in assay media supplied by MaTek, the assay medium was replaced with fresh media and 100 microL of the test substance supplied was applied to the top of each EpiOcular tissues.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- 100 microL or 100mg
- Duration of treatment / exposure:
- 1, 4, 64, 256 minutes
- Duration of post- treatment incubation (in vitro):
- see report
- Number of animals or in vitro replicates:
- Each treatment was conducted in duplicate
- Details on study design:
- see report
Results and discussion
In vitro
Results
- Irritation parameter:
- other: viability tissue %
- Run / experiment:
- ET50 > (256min)
- Value:
- 80.6
- Vehicle controls validity:
- not applicable
- 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:
- ET50 > 256 min. According to EpiOcular MTT Viability Assay, the substance is non-irritating, minimal.
- Executive summary:
the substance is non-irritating, minimal according to EpiOcular MTT Viability Assay
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
