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Description of key information

Skin irritation:

Skin irritation test was performed on rabbits to assess the irritation potential of chemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)}. 0.5% Basic violet 14 in Propylene glycol was applied to the skin of rabbits and observed for signs of irritation (duration and number of animals not mentioned). Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites. Hence, Basic Violet 14 can be considered to be not irritating to skin.

Eye irritation:

The (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} when applied on guinea pig eye at concentration of 0.1 ml, showed no ocular reaction on the treated eye. Thus under the test condition, the chemical (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) is considered as non-eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
The data was from safety assesment report.
Qualifier:
according to guideline
Guideline:
other: as mention below
Principles of method if other than guideline:
To evaluate the skin irritation potential for ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) on Rabbit
GLP compliance:
not specified
Specific details on test material used for the study:
IUPAC name:((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: Propylene glycol
Controls:
not specified
Amount / concentration applied:
0.5% in Propylene glycol
Duration of treatment / exposure:
No data available
Observation period:
No data available
Number of animals:
No data available
Details on study design:
No data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites.
Interpretation of results:
other: Not irritating
Conclusions:
Basic violet 14 when topically applied on rabbit skin produced no skin reaction.
Hence, Basic Violet 14 can be considered to be not irritating to skin.
Executive summary:

Skin irritation test was performed on rabbits to assess the irritation potential of Basic Violet 14. 0.5% Basci violet 14 in Propylene glycol was applied to the skin of rabbits and observed for signs of irritation (duration and number of animals not mentioned).

Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites.

Hence, Basic Violet 14 can be considered to be not irritating to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report.
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the eye irritation potential for ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) on guinea pig
GLP compliance:
not specified
Specific details on test material used for the study:
UPAC name: (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Species:
guinea pig
Strain:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Details on study design:
No data available.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular reaction were observed on the treated eye.
Other effects:
No data available
Interpretation of results:
other: Not irritating
Conclusions:
(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) did not produce any ocular reaction on the treated eye.

Executive summary:

(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) when applied on guinea pig eye in the concentration 0.1 ml particularly showed no ocular reaction on the treated eye.

 

As per the above test(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) is considered non eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Various studieshas been investigated for the test chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)}to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} and its structurally similar read across substancesBasic Violet 3 (CAS No: 548-62-9)andBasic violet 2 (CAS No: RA 3248-91-7).The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

 

The European Commission (EC) - Scientific Committee on Cosmetology (SCC) {Environment and Quality of Life - Reports (Seventh Series)- Basic violet 14 European Commission (EC) - Scientific Committee on Cosmetology (SCC) 1988} conducted skin irritation study on rabbits to assess the irritation potential of target chemical Basic Violet 14. 0.5% Basic violet 14 in Propylene glycol was applied to the skin of rabbits and observed for signs of irritation (duration and number of animals not mentioned). Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites. Hence, Basic Violet 14 can be considered to be not irritating to skin.

 

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin irritation potential was estimated for test chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} .The chemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} is estimated to be not irritating to skin of New Zealand White rabbits.

 

The dermal irritation potential of read across substance Basic Violet 3 was assessed by (Haskell Laboratory for Toxicology and Industrial medicine, Sustainability Support Services (Europe) AB has letter of access, 1974) in rabbits. 6 male albino rabbits were clipped free of hair on the trunk and lateral areas and placed in a FDA- type stocks. One inch squares of test material were applied to intact skin under 1inch*1inch gauze squares (double thickness). Rubber sheeting was loosely wrapped around the trunk and secured with an adhesive tape. After 24 hours, the rabbits were removed from the stocks and reactions were graded. Observations were also made at 48 hours. The observations were graded according to the system of the regulations of the Federal Hazardous Substances Act. Basic Violet 3 failed to produce any dermal reactions in the rabbits. Hence, Basic Violet 3 (CAS No: 548-62-9) was considered to be not irritating to rabbit skin.

The above results were further supported by the experimental study reported by Scientific Committee on Cosmetology (seventh series; 1988) for read across substance Basic violet 2 (CAS No: RA 3248-91-7) in rabbit. 0.5ml 10% aqueous solution was applied on the rabbit skin under occlusion. The above test did not induce any skin reaction. Hence, Basic violet 2 (CAS No: RA 3248-91-7) was considered non- skin irritant.

 

Thus on the basis of available data for thetarget chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} and its structurally similar read across substancesBasic Violet 3 (CAS No: 548-62-9)andBasic violet 2 (CAS No: RA 3248-91-7),it can be concluded thatchemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} is unable to cause skin irritation and considered as not irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

 

Eye irritation:

In different studies,the test chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} has been investigated for potential for ocular irritationto a greater or lesser extent. The studies are based on in vivo experiments in rabbits and guinea pigs for target chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)}its structurally similar read across substances 4,4'- Diaminodiphenylmethane (CAS No: 101-77-9)and Basic Violet 1 (CAS no: 8004-87-3).The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

 

The European Commission (EC) - Scientific Committee on Cosmetology (SCC) {Environment and Quality of Life - Reports (Seventh Series)- Basic violet 14 European Commission (EC) - Scientific Committee on Cosmetology (SCC) 1988} conducted ocular irritation study on rabbits for target chemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} . The chemical when applied on guinea pig eye at concentration of 0.1 ml, the treated rabbits showed no ocular reaction on the treated eye. Thus under the test condition, the chemical (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) is considered as non-eye irritant.

 

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the eye irritation potential was estimated for test chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} .The chemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} is estimated to be not irritating to eye of New Zealand White rabbits.

 

 

THE European Chemicals Bureau (ECB) {IUCLID Dataset - 4,4'-Methylenedianiline; EUROPEAN COMMISSION – European Chemicals Bureau, 18–FEB–2000} reported an ocular irritation study of read across chemical 4,4'- Diaminodiphenylmethane (CAS No: 101-77-9) carried out on 2 New Zealand White rabbits which supports the above mentioned results. About 10–20 mg of4,4'- Diaminodiphenylmethane installed into the was placed in the conjunctival sac of 1 eye of each rabbit, with the other eye as the control.A visual assessment of irritancy was made after 3 hours, and after 1, 2, 3, and 7 days. Since no ocular lesions were observed during the observation period, the chemical 4,4'- Diaminodiphenylmethane (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ eye.

 

The above results were further supported by the experimental study conducted by Commission of the European Communities {Directorate-General Environment, Consumer Protection and Nuclear Safety- Commission of the European Communities- Brussels Luxembourg, 1988} for read across substance Basic Violet 1 (CAS no: 8004-87-3). No eye ocular lesions were observed when the rabbits were tested at 0.1% aqueous solution of test substance. Hence the chemical Basic Violet 1 (CAS no: 8004-87-3) was considered to be not irritating to the rabbits’ eye.

 

Thus on the basis of available data for thetarget chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} and its structurally similar read across substances4,4'- Diaminodiphenylmethane (CAS No: 101-77-9)and Basic Violet 1 (CAS no: 8004-87-3),it can be concluded thatchemical (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} is unable to cause eye irritation and considered as not irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} and its structurally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)}is unlikely to cause skin and eye irritation. Hence(4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)}can be classified under the category “Not Classified” for skin and eye as per CLP.