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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:
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

Reference
Reference Type:
publication
Title:
Cosmetics Europe compilation of historical serious eye damage/eye irritation in vivo data: the Draize eye test Reference Database (DRD)
Author:
João Barroso, Uwe Pfannenbecker, Els Adriaens, Nathalie Alépée, Magalie Cluzel, Ann De Smedt, Jalila Hibatallah, Martina Klaric, Karsten R. Mewes, Marion Millet, Marie Templier, Pauline McNamee
Year:
2017
Bibliographic source:
Archives of toxicology, 91(2), 521-547,2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize method
Principles of method if other than guideline:
To assess the ocular irritation potential of 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride in rabbits according to Draize method
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid crystalline powder
Details on test material:
- Name of test material: C.I. Basic Violet 2 / (4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride)
- IUPAC name: 4-[(4-amino-3-methylphenyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline hydrochloride
- Molecular formula: C22H24ClN3
- Molecular weight: 365.906 g/mole
- Smiles :C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
- Inchl: 1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
- Substance type: Organic
- Physical state: Dark green powder
Specific details on test material used for the study:
- Name of test material: C.I. Basic Violet 2 / (4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride)
- IUPAC name: 4-[(4-amino-3-methylphenyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline hydrochloride
- Molecular formula: C22H24ClN3
- Molecular weight: 365.906 g/mole
- Smiles :C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
- Inchl: 1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
- Substance type: Organic
- Physical state: Solid Green crystalline powder
- Obtained from: Sigma Aldrich
- Purity: Analytical Grade

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
From 1 hour till 21 days after instillation of test chemical
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1
Details on study design:
SCORING SYSTEM: Draize method
Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical

Results and discussion

Other effects / acceptance of results:
no data available
Results of in vivo study
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The study was terminated after day 1 since color staining of the cornea was observed.

Any other information on results incl. tables

Table: Draize eye test reference database

Name of the test chemical

CAS number

Substance class

Physical state

Purity

Commercial source

UN GHS category

Number of animals

Comments

4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride

3248-91-7

Allyl|

Anilines|

Benzyl|

Conjugated hydrocarbon|

Dianilines|

Ketimine

Solid

Analytical standard

Sigma –Aldrich

CAT 1

1/1

The study was terminated after day 1 since color staining of the cornea was observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The study was terminated after day 1 since color staining of the cornea was observed.
Based on these observations, 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.
Executive summary:

An eye irritation study in rabbits was conducted to assess the irritation potential of 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride.The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.

The study was terminated after day 1 since color staining of the cornea was observed.

Based on these observations,4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloridewas considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.