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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 276-896-4 | CAS number: 72828-93-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1983
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate
- EC Number:
- 276-896-4
- EC Name:
- 3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate
- Cas Number:
- 72828-93-4
- Molecular formula:
- C27H30N3O2.CH3O4S C28H33N3O6S
- IUPAC Name:
- trimethyl[3-({4-[(4-methylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)propyl]azanium methyl sulfate
- Test material form:
- solid
- Details on test material:
- Basic Blue 45 MeSO4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd. Huntingdon, UK
- Housing: single cage
- Weight: 3.0 - 3.2 kg
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): as lib.
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60% r.h.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline after 24 h
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Remarks on result:
- not determinable
- Remarks:
- heavy staining
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Remarks on result:
- not determinable
- Remarks:
- heavy staining
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2, 3
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- All animals reacted with severe irritation symptoms at the conjunctivae (reversible within 14 d). From 24 h after treatment the cornea was completely stained blue, the substance was not removable with physiological saline; an effect on deeper tissues and layers of the cornea can be considered (not reversible within 21 d). Effects on iris could not be determined to heavy blue staining. Chemosis reaction was found moderate to severe (reversible within 14 d).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on an OECD 405 study with rabbits, the substance causes severe damage to eyes. The substance is classifiable according to GHS Category 1 due to the lack of reversibility within 21 d (cornea staining).
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.
