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Reaction mass of sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
EC number: 915-758-6 | CAS number: -
- 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:
- 2016-11-02 to 2017-07-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010-07-22
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012-07-06
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
- EC Number:
- 915-758-6
- Molecular formula:
- C32H18CrN6O8.Na / C32H22CrN10O8.Na / C32H20CrN8O8.Na
- IUPAC Name:
- Reaction mass of sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: N01-131001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / dark brown
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.,Inc., 5960 AD Horst, The Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 17.6 g – 21.8 g
- Housing: single housed in polycarbonate cages type MII with mesh wire tops
- Diet: Kliba mouse/rat maintenance diet “GLP” (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland) ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light from 06:00 h to 18:00 h; 12 hours darkness from 18:00 h to 06:00 h
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Remarks:
- MEK was used as the vehicle because good homogeneity of the preparation was achieved.
- Concentration:
- 5, 10, 25 %
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test-substance preparation was produced on a weight per weight basis shortly before the application by stirring with a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
- Systemic toxicity: No signs of systemic toxicity were observed in the pretest.
- Irritation: Excessive local skin irritation was observed after application of the 50 % concentration. At the tested 10 % concentration no relevant signs of local irritation were observed.
- Ear weights measurements: ≥ 25 % increase (50 % concentration)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
In order to reveal a possible induction of sensitization, the response in the draining lymph node after epicutaneous application of several concentrations of the test substance to the skin of the dorsal surface of both ears is determined by measuring 3H-thymidine incorporation into the lymph node cells. Additional parameters used to characterize the response are, lymph node cell count and, to a certain extent, lymph node weight. Because irritation by the test substance may also induce lymph node responses, the weights of ear punches taken from the area of test-substance application are determined as an indicator for inflammatory ear swelling due to any irritant action of the test substance. A test item is regarded as a sensitizer in the LLNA if exposure to at least one concentration of the test item results in an incorporation of 3H thymidine at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index (SI ≥ 3.0). However, the biological relevance of the obtained stimulation indices is considered in conjunction with the other assessed end points (i.e. cell counts, lymph node weights, ear weights). Hereby, the thresholds used for assessment of cell counts and ear weights are represented by stimulation indices (SI) of 1.5 and 1.25, respectively.
If applicable, the EC (estimated concentration) leading to the respective SI values were calculated by linear or semi-logarithmical regression between the data points directly below and above the SI if possible or using the two nearest points below or above the SI.
TREATMENT PREPARATION AND ADMINISTRATION:
Epicutaneous application of 25 µL at the dorsal part of the ear is simulating dermal contact with the compound which is possible to occur under practical use conditions. 3 consecutive applications (day 0 – day 2) to the same application site were performed. On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected into a tail vein with 20 µCi of 3H-thymidine in 250 µL of sterile saline. - Positive control substance(s):
- other: A concurrent positive control (reliability check) with a known sensitizer was not included in this study.
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The stimulation indices of 3H-thymidine incorporation, cell count, lymph node weight and ear weight measurements were calculated as the ratio of the test group mean values for these parameters divided by those of the vehicle control group.
3H-thymidine incorporation, cell count, lymph node weight and ear weight were analysed via WILCOXON - Test.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 25 %
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 10 %
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 5 %
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
A biologically relevant and statistically significant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts was observed at the 25 % and 10 % concentrations. The increase at 5 % was statistically significant, but failed to reach the cut off.
The test-substance concentrations did not cause increases (SI > 1.25) in ear weights, demonstrating the absence of relevant ear skin irritation.
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION
CLINICAL OBSERVATIONS
Slight or moderate dark brown discoloration of the ear skin was noted during the observation period at all concentrations. No signs of systemic toxicity were noticed in all animals during general observation, but one animal of the 25 % concentration was found dead 3 days after the first application. Dark brown discoloration of feces was noted at all concentrations during the observation period. No macroscopic pathologic abnormalities (Organs without gross lesions) were noted in the animal which was found dead 3 days after the 1st treatment with the 25% concentration.
BODY WEIGHTS
No relevant influence on the body weights was observed in the course of the study.
Any other information on results incl. tables
Table 1: Summary of the stimulation indices
Treatment |
3H-thymidine Incorporation Stimulation Index |
Cell Count Stimulation Index |
Lymph Node Weight Stimulation Index |
Ear Weight Stimulation Index |
Vehicle Control |
1.00 |
1.00 |
1.00 |
1.00 |
5 % in MEK |
0.88 |
1.29* |
1.19* |
1.05 |
10 % in MEK |
1.80 |
1.74** |
1.31 |
1.03 |
25 % in MEK# |
1.44 |
1.67** |
1.33 |
1.07 |
* p ≤ 0.05; ** p ≤ 0.01 # Calculation on basis of 4 animals because 1 animal was found dead 3 days after the first application |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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