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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-603-8 | CAS number: 831-52-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- OPINION ON Picramic acid and sodium picramate COLIPA n° B28
- Author:
- Scientific Committee on Consumer Safety,
- Year:
- 2 012
- Bibliographic source:
- Scientific Committee on Consumer Safety, (SCCS) 18 September 2012
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Sodium Picramate
- Author:
- Cosmetic Ingredient Review Panel
- Year:
- 1 992
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY; Volume 11, Number 4,1992
- Reference Type:
- publication
- Title:
- Amended Safety Assessment of Sodium Picramate and Picramic Acid
- Author:
- Lillian C. Becker, Wilma F. Bergfeld, Donald V. Belsito, Curtis D. Klaassen, JamesG.Marks Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, and F. Alan Andersen
- Year:
- 2 009
- Bibliographic source:
- International Journal of Toxicology; 28(Suppl 3); 205S-216S, 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the eye irritation potential of the test chemical in albino rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 2-amino-4,6-dinitrophenoxide
- EC Number:
- 212-603-8
- EC Name:
- Sodium 2-amino-4,6-dinitrophenoxide
- Cas Number:
- 831-52-7
- Molecular formula:
- C6H5N3O5.Na
- IUPAC Name:
- sodium 2-amino-4,6-dinitrophenoxide
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:
- other: 2.5% aqueous test chemical (buffered to pH 7)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1ml of 2.5% aqueous test chemical (buffered to pH 7)
- Duration of treatment / exposure:
- the lids were held together for 1 second
- Observation period (in vivo):
- 24, 48, and 72 hours
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: At 10 seconds post-instillation, the eyes were rinsed with 20 mL of distilled water
Observation period:Reactions were scored at 24, 48, and 72 hours post-instillation.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mild conjunctival inflammation was observed in each animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Mild conjunctival inflammation was observed in each animal. It can be considered that 2.5% aqueous test chemical solution (buffered to pH 7) was not an ocular irritant
- Executive summary:
The eye irritation potential of the test chemical was assessed in albino rabbits.
0.1 ml of 2.5% aqueous test chemical (buffered to pH 7) was instilled into the eyes of albino rabbits (N = 3) and the lids were held together for 1 second. At 10 seconds post-instillation, the eyes were rinsed with 20 mL of distilled water. Untreated eyes served as controls. Reactions were scored at 24, 48, and 72 hours post-instillation.
Mild conjunctival inflammation was observed in each animal. It can be considered that 2.5% aqueous test chemical solution (buffered to pH 7) was not an ocular irritant
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.
