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EC number: 224-618-7 | CAS number: 4430-18-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 3 February 2004 to 16 February 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 24th April 2002
- Deviations:
- yes
- Remarks:
- The storage temperature of the test item was above +4 deg Celsius on one occasion for a total of 6 hours. The deviation did not compromise the validity and integrity of the study
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- EC Number:
- 224-618-7
- EC Name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- Cas Number:
- 4430-18-6
- Molecular formula:
- C21H15NO6S.Na
- IUPAC Name:
- sodium 2-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-5-methylbenzenesulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied by l'Oreal / Batch no. 10130
- Expiration date of the lot/batch: March 2005
- Purity test date: 31 March 2004
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: not specified
- Specific activity: 25 Ci/mmol
- Locations of the label: 3H-Tdr / 3H methyl-thymidine, provided by Amersham (France)
- Expiration date of radiochemical substance: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +4 deg celsius, protected from light and under nitrogen gas
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: water : <1g/100ml / Ethanol : <1g/100ml / DMSO : <1g/100ml
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was prepared as a solution in the vehicle at the chosen concentrations. The test item dosage forms were prepared extemporaneously under nitrogen atmosphere and were stored protected from light and under nitrogen gas before use. They were used within the 4 hours following the preparation according to the known stability results (CIT/Study No. 26931 AHS).
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier (France)
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: no information
- Age at study initiation: 9 weeks old
- Weight at study initiation: 19.3±0.8g
- Housing: Individually housed individually in disposable crystal polystyrene cages (22 x 8.5 x 8.0 cm)
- Diet (e.g. ad libitum): free access to A04 C pelleted diet (SAFE, France)
- Water (e.g. ad libitum): tap water (filtered using a 0.22 micron filter) contained in bottles.
Each batch of diet is analyzed for composition and contaminant level by the supplier.
- Acclimation period: at least 5 days before the beginning of the study
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h
- IN-LIFE DATES: Preliminary study From: 3 February 2004 To: 11 February 2004
Main study 11 February 2004 To: 16 February 2004
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary study : 1.5, 3, 6 and 15% pure dye (w/v)
Main study :0, 0.6, 1.5, 3, 6, 15, 25% pure dye (w/v) - No. of animals per dose:
- Main study : 4 mice per group P
Preliminary study : four mice for the study - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 15% in vehicle : maximum practicable concentration
- Ear thickness measurements: using a micrometer
- Erythema scores: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA Local Lymph Node Assay
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION:
On days 1, 2 and 3, a dose-volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an optimized application of the test material, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application.
Bodyweight and Clinical signs were releved during the study.
Ear thickness measurements and recording of local reactions were performed in order to assess any possible irritant effect of the test item, as possible irritancy may be involved in false positive lymphoproliferative responses.
On days 1, 2 and 3 (before application) as well as on day 6 (after sacrifice), the thickness of the left ear of each animal of groups 1 to 6 was measured.
AURICULAR NODES SAMPLES
On day 6, all animals of all groups received a single intravenous injection of 250 μL of 0.9% NaCl containing 20 μCi of 3H-TdR via the tail vein. Approximately 5 hours later, the animals were killed by cervical dislocation and the auricular lymph nodes were excised. The lymph nodes were pooled for each experimental group. Cell suspensions were prepared by mechanical dissagregation thereafter resuspended in NaCl solution and viability (by trypan blue) was performed. Each suspension was centrifugated. 3H-Tdr incorporation was measured by Beta-scintillation counted.
Stimulation index (SI) was calculated as follows : SI = dpm of treated group / dpm of control group - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI = 6.55) were noted. The study was therefore considered valid.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- 1.55
- Test group / Remarks:
- 15% dose group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
No lymphoproliferation was noted at any tested concentrations, while significant lymphoproliferation was observed with HCA at 25%.
DETAILS ON STIMULATION INDEX CALCULATION
Stimulation Index SI = dpm of treated group / dpm of control group
EC3 CALCULATION
EC3 value = theorical concentration resulting in a SI value of 3
CLINICAL OBSERVATIONS:
No mortality and no clinical signs were observed during the study
BODY WEIGHTS
The body weight changes were similar for control and treated animals in both experiments
LOCAL IRRITATION
No cutaneous reactions and no increases in ear thickness were observed in the animals of the treated groups.
A black coloration of the skin of the ears which could have masked a possible discrete erythema was noted in all treated animals on days 2 and 3 or from day 2 up to day 6.
Any other information on results incl. tables
Table 1: Study results
Groups |
Treatment and concentrations |
Cell count |
viability(%) |
Amount of cells (x 106cells) |
cellularity index |
Number of nodes pergroup |
dpmper group |
dpmper node |
Stimulation index (SI) |
Increase in ear thickness (% between day 1 and day 6) |
EC3 value |
Irritationclasse |
|
viable |
dead |
||||||||||||
1 |
Acetone / olive oil 0 |
141 14
116 15
124 26
100 30
100 23
151 19
220 43 |
90.97
88.55
82.67
76.92
81.30
88.82
83.65 |
7.05
5.80
6.20
5.00
5.00
7.55
22.00 |
|
8
8
8
8
8
8
8 |
569.60
492.27
689.54
486.58
546.17
885.48
3730.37 |
71.20
61.53
86.19
60.82
68.27
110.69
466.30 |
|
3.00
0.00
6.19
4.12
2.04
4.90 |
|
|
|
2 |
Acid Violet 43 (C063) 0.6%* |
0.82
0.88
0.71
0.71
1.07
3.12 |
0.86
1.21
0.85
0.96
1.55
6.55 |
NA |
I |
||||||||
3 |
Acid Violet 43 (C063) 1.5%* |
||||||||||||
4 |
Acid Violet 43 (C063) 3%* |
||||||||||||
5 |
Acid Violet 43 (C063) 6%* |
||||||||||||
6 |
Acid Violet 43 (C063) 15%* |
||||||||||||
7 |
HCA 25% |
|
|
|
|||||||||
NA = not applicable
dpm= disintegrations per minute
Viability = Viable cells / Viable cells + dead cells
Cellular index= amountof cells (x10E6cells) in the treated / amount of cells (x10E6cells) in the vehicle group
* = expressed in % active dye (w/v)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the registered substance Jarocol Violet 43 did not induced delayed contact hypersensitivity in murine LLNA.
- Executive summary:
This GLP compliant study was performed to assess the potential sensitisation property of the test item Jarocol Violet 43 by contact in mice during a Local Lymph Node Assay (LLNA) according OECD guideline 429 method.
Animals were separated in 7 groups (4 mice/group) consisting of 5 treated groups receiving Jarocol Violet 43, a negative control group receiving the vehicle (AOO) alone and a positive control group receiving alpha-hexylcinnamaldehyde (HCA), at 25% (v/v) in AOO. The vehicle was selected in a previous solubility study showing that 15% (w/v) active Jarocol Violet 43 was the maximal practicable concentration, and that this concentration was non-irritant in a preliminary irritation test. During induction period test substances were applied over the ears (25 μL per ear) for three consecutive days. After 2 days of resting, the proliferation of lymphocytes in the lymph nodes draining the application sites was measured by incorporation of tritiated methyl thymidine (day 6). The values obtained were used to calculate stimulation indices (SI). The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.
No cutaneous reactions and no increases in ear thickness were observed in animals treated with the test substance. No lymphoproliferation was observed at any tested concentration (SI ranging from 0.9 for 0.6% to 1.6 for 15% active dye).
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