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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-019-2 | CAS number: 25481-21-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The Draize eye test Reference Database (DRD)
- Author:
- João Barroso et.al
- Year:
- 2 017
- Bibliographic source:
- Archives of toxicology,2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the ocular irritation potential of the test chemical in rabbits according to Draize method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethylenediaminetetraacetic acid dipotassium salt dihydrate
- Cas Number:
- 25102-12-9
- Molecular formula:
- C10H18K2N2O10
- IUPAC Name:
- Ethylenediaminetetraacetic acid dipotassium salt dihydrate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Ethylenediaminetetraacetic acid dipotassium salt dihydrate
InChI: 1S/C10H16N2O8.2K.2H2O/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19)20;;;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;;2*1H2/q;2*1;;/p-2
- Molecular formula: C10H18K2N2O10
- Molecular weight: 404.455 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: >99%
- Obtained from: Sigma Aldrich
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- From 1 hour till 21 days after instillation of test chemical
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1
- Details on study design:
SCORING SYSTEM: Draize method
Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical
Results and discussion
In vivo
Results
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal opacity was observed in the rabbits at all observation times.
Any other information on results incl. tables
Table: Draize eye test reference database
Physical state |
Purity |
Commercial source |
UN GHS category |
Number of animals |
Comments |
Solid |
≥99% |
Sigma –Aldrich |
NC |
NO DATA |
CO>0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.
- Executive summary:
An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical.The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.
No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.
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.
