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Toxicological information

Eye irritation

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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:
2004
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:
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
Name:
Unnamed
Type:
Constituent
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

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.