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EC number: 211-189-6 | CAS number: 632-99-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
Reference
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.
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