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Description of key information

Skin sensitization test was performed using basic violet 14 as test material on guinea pigs. The test material was applied topically 5% in 25%Aqueous solution of gum Arabic to the skin of guinea pigs for 5 days. After 2 weeks of rest period the challenge treatment was provided by epicuteneous injection of concentration 0.1ml 0.01, 0.001, and 0.001% in saline. The guinea pigs were observed for signs of dermal sensitization after the challenge exposure. No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 skin sensitization potential of ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
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:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data avialable
Route:
intradermal
Vehicle:
other: Aqueous solution of gum arabic
Concentration / amount:
5% in 25 % Aqueous solution of gum arabic
Day(s)/duration:
5 days
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
other: saline
Concentration / amount:
0.1ml 0.01, 0.001, and 0.001% in saline.
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
not specified
Details on study design:
RANGE FINDING TESTS: No data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: no data
- Test groups: No data
- Control group: No data
- Site: No data
- Frequency of applications: daily for 5 days
- Duration: 5 days
- Concentrations: 5% in 25% Aqueous solution of gum arabic

B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Day(s) of challenge: no data
- Exposure period: no data
- Test groups: no data
- Control group: no data
- Site: no data
- Concentrations: 0.1ml 0.01, 0.001, and 0.001% in saline
- Evaluation (hr after challenge): no data
Challenge controls:
Not specified
Positive control substance(s):
no
Reading:
1st reading
Group:
test chemical
Dose level:
0.1ml 0.01, 0.001, and 0.001% in saline
Clinical observations:
No dermal reaction were observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.
Executive summary:

Skin sensitization test was performed using basic violet 14 as test material on guinea pigs. The test material was applied topically 5% in 25%Aqueous solution of gum Arabic to the skin of guinea pigs for 5 days. After 2 weeks of rest period the challenge treatment was provided by epicuteneous injection of concentration 0.1ml 0.01, 0.001, and 0.001% in saline. The guinea pigs were observed for signs of dermal sensitization after the challenge exposure.

No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization:

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 skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in 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)} 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 sensitization study on rabbits of target chemical Basic Violet 14. The test material was applied topically 5% in 25%Aqueous solution of gum Arabic to the skin of guinea pigs for 5 days. After 2 weeks of rest period the challenge treatment was provided by epicuteneous injection of concentration 0.1ml 0.01, 0.001, and 0.001% in saline. The guinea pigs were observed for signs of dermal sensitization after the challenge exposure. No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.

 

The skin sensitization potential of (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. The substance (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} was estimated to be not sensitizing to the skin of guinea pigs. Based on the estimated result (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride {Basic Violet 14 (CAS No: 632-99-5)} can be considered to be not sensitizing to guinea pigs.

 

The JOE DINARDO et al., { j. Cosmet. Sci.., 58, 209-214 (May/June2007)} performed skin sensitization test for read across Basic violet 3(CAS No: 548-62-9) in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration (100%,50%, and 25% of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.  No erythema/edema was observed after 24 and 48 hours post-application. Hence the test substance Basic violet 3(CAS No: 548-62-9) was considered as not sensitizing to the guinea pigs skin.

 

The above results were further supported by the experimental study reported by Scientific Committee on Consumer Safety {The Scientific Committee on Consumer Products, SCCS/1340/10,2011} for read across substance Basic violet 2 by guinea pig maximization test. The test group consisted of 20 female Guinea pigs, two control groups of ten female Guinea pigs each. In the first week of induction, the test group was treated with single intradermal injections of complete Freund's adjuvant/water mixture 1:1 (v/v), 1% of the test substance in sterile water and with 1% of the test substance emulsified in Freund's complete adjuvant. The negative control groups were treated with the adjuvant and the vehicle (sterile water) in the same manner. Seven days after injection, a 50% solution of the test substance in sterile water was dermally applied under occlusive dressing for 48 h to the area of the intradermal injections. The negative control group was treated with the vehicle alone. After a period of 2 weeks without treatment, sensitisation reactions were challenged in the test group as well as in one negative control group by dermal administration of the test substance in sterile water (50%, on one flank and vehicle alone on the contralateral flank) under occlusive dressing for 24 hours. 24 and 48 hours after removal of the patches the skin reactions were scored. Following the 48 hour examination at challenge, skin fold thickness of the treated sites was measured using a digital micrometer. Body weights were recorded on days 1 and 25 (termination of the study). Body weights were not affected by the test compound. Basic violet 2 (CAS No: RA 3248-91-7) was considered non-sensitizing as no skin reactions were observed.

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 sensitization and considered as non-skin sensitizer.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance (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 substances Basic Violet 3 (CAS No: 548-62-9)andBasic violet 2 (CAS No: RA 3248-91-7) were observed in various studies. From the results obtained from these studies it is concluded 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 not likely to cause skin sensitization and hence can be classified as non -skin sensitizer.