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EC number: 221-490-4 | CAS number: 3118-97-6
- 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:
Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R to evaluate the skin sensitizing potential of the test substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6). The patch of 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was applied onto the back of each patient for 24 hours by using Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days. Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction to Since the positive reactions were seen in 2 out of total 8 cases, the test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) was considered to be sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
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:
- 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 journal
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R to evaluate whether the test substance Sudan II is a potential skin sensitizer or not.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C.I. Solvent orange 7
- Molecular formula: C18H16N2O
- Molecular weight : 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
- Smiles : Cc1ccc(N=Nc2c(O)ccc3ccccc23)c(C)c1
- InChI: 1S/C18H16N2O/c1-12-7-9-16(13(2)11-12)19-20-18-15-6-4-3-5-14(15)8-10-17(18)21/h3-11,21H,1-2H3/b20-19+ - Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% in petrolatum
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% in petrolactum
- No. of animals per dose:
- 8
- Details on study design:
- OTHER: The tests were performed with Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). The application was performed on the back for 2 days. Readings were made according to the ICDRG classification 24 h after the patches were removed.
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- Positive effects observed
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: sensitising
- Conclusions:
- Positive reactions were seen in 2 out of total 8 cases. Thus the test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) was considered to be sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
- Executive summary:
Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R to evaluate the skin sensitizing potential of the test substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6).
The patch of 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was applied onto the back of each patient for 24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessedaccording to the ICDRG classification for 2 days.
Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction to
Since thepositive reactions were seen in 2 out of total 8 cases,the test chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6)was considered to be sensitizingin human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
Reference
Other details not known
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization:
Various studies has been investigated for the test chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6)to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) and its structurally similar read across substances 1-(phenyldiazenyl)-2-naphthol (CAS No: 842-07-9) and in vivo mouse local lymphnode assay (LLNA) in another structurally similar read across substances1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6).The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;
The Skin sensitization study was performed byTAKEHITO KGZUKA, MINORU TASHIR0, SHIGEHARU SANO, KEIICHI FUJIMOTO, YUMI NAKAMURA, SEIICHI HASHIMOTO AND GEN NAKAMINAM (1980) in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R to evaluate the skin sensitizing potential of the test substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6). The patch of 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was applied onto the back of each patient for 24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessedaccording to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction. Since thepositive reactions were seen in 2 out of total 8 cases,the test chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6)was considered to be sensitizingin human patients.
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor,skin sensitization potential estimated was 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6). The substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) is to be sensitizing to the skin of guinea pig.
The above results were supported by experimental study conducted by DENISE M. SAILSTAD, JEFFREY S. TEPPER, DONALD L. DOERFLER, MOHAMMAD Qasim AND MARYJANE K. SELGRADE in 1994 forstructurally similar read across substances 1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6). This Skin sensitization study for 1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6) was observed in female Balb/c mice by using LLNA mode. Twenty-five microliters of the agent (acetone-dye solutions) or acetone (negative-vehicle control) was applied to the ears of Balb/c mice for 3 days. On the fourth day, mice were terminated by cervical dislocation and the auricular lymph nodes were removed. Aseptic techniques were used throughout the assay. Due to the sparse number of cells in each node, pools were made using the nodes of 3 mice. Three pools were used for each agent (dye or positive control) or acetone control group. Pooled nodes were homogenized to single-cellsuspension using glass tissue grinders. Cell viabilities were evaluated using trypan blue exclusion and were above 90% for each pool. Cell mixtures of 1.2 X 10* cells were added to the wells of a 96-well microtiter plate in an RPMI 1640 media containing L-glutamine, 25 mM Hepes, 10% fetal bovine serum, and2%penicillinstreptomycin (Gibco Laboratories). Triated [3H]thymidine (2 ^Ci/well) (NEN Dupont, Boston, MA) was added to each well and incubated for 24 hr at 37°C and 5% CO2. The cells from each well were harvested onto filter disks using a Skatron cell harvester. Incorporation of 3H was determined using a beta scintillation counter. Experimental and control groups each contained nine mice. Groups were divided into three subgroups or "pools" of three mice each. Auricular lymph nodes from each pooled subgroup were processed as previously described. The counts per minute were obtained from triplicates of each pool. The average of these triplicate readings was used as input for the statistical evaluation using an analysis of variance (ANOVA). Analysis of the individual dye compounds, in which two separate experiments were performed, was adjusted for differences between the two replicates. Pairwise comparisons among different agents were performed as subtests of the overall ANOVA. Significance levels were adjusted for multiple comparisons using a modified Bonferroni correction. However 1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229 -55-6) was statistically different from the control. The response to 3% glutaraldehyde was used as a positive control in this experiment. Differences in acetone controls indicate normal variability. Therefore 1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6) was considered to be sensitizing in mice by LLNA mode.
TAKEHITO KGZUKA, MINORU TASHIR0, SHIGEHARU SANO, KEIICHI FUJIMOTO, YUMI NAKAMURA, SEIICHI HASHIMOTO AND GEN NAKAMINAM (1980) performed same study (mentioned above for target CAS) for anotherstructurally similar read across substances 1-(phenyldiazenyl)-2-naphthol (CAS No: 842-07-9)in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red Rwhich further supports the above results.All thehuman patients showed positive skin sensitizing reactions (8/8).Thusthe chemical1-(phenyldiazenyl)-2-naphthol (CAS No: 842-07-9) was considered to be sensitizingin human patients.
Based on the available data for the target substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) and its structurally similar read across substances1-(phenyldiazenyl)-2-naphthol (CAS No: 842-07-9)and1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6) ,it can be concluded thatchemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) is able to cause skin sensitization and thus can be considered as sensitizing .
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Justification for classification or non-classification
The skin sensitization potential of test substance substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) and its structurally similar read across substances1-(phenyldiazenyl)-2-naphthol (CAS No: 842-07-9)and1-[(2-methoxyphenyl)diazenyl]-2-naphthol(1229-55-6) were observed in various studies. From the results obtained from these studies it is concluded that the chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) is able to cause skin sensitization and hence can be classified as skin sensitizing.
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