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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Final report on the safety assessment of Basic Violet 1, Basic Violet 3, and Basic Violet 4
Author:
C. Diamante et al.
Year:
2009
Bibliographic source:
International Journal of Toxicology, 28(Suppl 3) 193s-204s

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: no information on the method
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
EC Number:
210-042-3
EC Name:
4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
Cas Number:
603-47-4
Molecular formula:
C24H27N3.ClH
IUPAC Name:
4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
1% Gential Violet
Duration of treatment / exposure:
Administration 3 times a day but duration is not reported (at least 3 days)
Observation period (in vivo):
No information
Number of animals or in vitro replicates:
2 rabbits

Results and discussion

In vivo

Results
Irritation parameter:
other: no information on the measured parameters
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The two rabbits developed conjunctival congestion and discharge the day following the administration of 1% gentian violet. After 3 days of instillation, there was some necrosis of the conjunctiva.
Conjunctival biopsies had variable thinning of epithelial lining with total loss of goblet cells and subepithelial capillary congestion with neutrophilic infiltration.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
When 1% gentian violet was instilled in the eye of 2 rabbits 3 times a day (duration not reported), both animals developed conjunctival congestion and discharge the day following the administration of gentian violet. After 3 days of instillation, there was some necrosis of the conjunctiva. Conjunctival biopsies had variable thinning of epithelial lining with total loss of goblet cells and subepithelial capillary congestion with neutrophilic infiltration.
As no information regarding the reversibility of the effect nor on the measured parameters are mentioned, the classification can not be determined.