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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-816-1 | CAS number: -
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
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
Test material
- Reference substance name:
- previous identifier no longer suitable
- EC Number:
- 947-816-1
- Cas Number:
- 00-00-0
- Molecular formula:
- previous identifier no longer suitable
- IUPAC Name:
- previous identifier no longer suitable
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- other: bovine
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 30.38
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: Opacity
- Run / experiment:
- mean
- Value:
- 30
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: Permeability
- Run / experiment:
- mean
- Value:
- 0.025
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- It was concluded that Reaction Mass of Sodium Methyl Sulphate and
1-Methylpyridinio-3-carboxylate, produced an IVIS score of 30.38 and no prediction
can be made in respect of its potential to cause eye irritation.
Classification as Rye Irr. 2 according to precaution principle.
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.
