Registration Dossier
Registration Dossier
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EC number: 208-953-6 | CAS number: 548-62-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS
- Year:
- 2 004
- Bibliographic source:
- adopted by the SCCNFP on 23 April 2004 by means of the written procedure
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- EC Number:
- 208-953-6
- EC Name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Cas Number:
- 548-62-9
- Molecular formula:
- C25H30ClN3
- IUPAC Name:
- 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium chloride
- Test material form:
- solid
- Details on test material:
- - Name (IUPAC): 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium chloride
- Name of test material (as cited in study report): Gentian Violet
- Molecular formula: C25H30ClN3
- Molecular weight: 407.986 g/mol
- Smiles notation): CN(C)C1=CC=C(C=C1)C(=C2C=CC(=[N+](C)C)C=C2)C3=CC=C(C=C3)N(C)C.[Cl-]
- InChl : InChI=1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Observation period (in vivo):
- 24 hours
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Score:
- > 2 - < 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Results
Intense staining of the eye and adnexa occurred. Chemosis score 2 of the conjunctiva was reported 1 hour after dosing, increasing to score 4 at 24h. Discolouration of the nictitating membrane, possibly indicating corrosive actions of the test substance, was also noted at the 24h observation time. Marked to severe corneal opacity was apparent after 24 hours. The study was terminated after 24h. No indication of a systemic effect could be detected.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Conclusions:
- Based on these results, the undiluted test compound has to be labelled "R41: Risk of serious damage to eyes. " according to Commission Directive 2001/59/EC
- Executive summary:
Intense staining of the eye and adnexa occurred. Chemosis score 2 of the conjunctiva was reported 1 hour after dosing, increasing to score 4 at 24h. Discolouration of the nictitating membrane, possibly indicating corrosive actions of the test substance, was also noted at the 24h observation time. Marked to severe corneal opacity was apparent after 24 hours. The study was terminated after 24h. No indication of a systemic effect could be detected.
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