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Diss Factsheets
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EC number: 284-628-2 | CAS number: 84961-40-0
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-04-07 to 2016-07-25
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015-07-28
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- EC Number:
- 284-628-2
- EC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- Cas Number:
- 84961-40-0
- Molecular formula:
- C32H22CrN10O8.C10-14H21-29NH2
- IUPAC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- Test material form:
- solid
- Details on test material:
- - State of aggregation: solid (powdeQ
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 002-141407, Test-substance No.: 16/0046-1
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / orange, pH ~ 5 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200
- Tissue lot number: 23328
- Date of initiation of testing: 2016-04-12
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature, 37 °C, incubator
- Temperature of post-treatment incubation: 37 °C, incubator
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were washed with sterile PBS to remove residual test substance.
- Observable damage in the tissue due to washing: Due to mechanical damage of tissue 1 during the washing procedure, only two tissues of the negative control could be evaluated. Since the OD570 values of tissue 2 and 3 are well within the historical control data, this deviation is not considered to adversely affect the result of this study.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm, without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
MTT QC assay, 4 hours.
Acceptance criteria OD (540 - 570 nm) [1.0 - 3.0]
Result:1.744 ± 0.201
- Barrier function:
ET-50 assay, 100 µL 1 % Triton X-100. 4 timepoints, n = 3, MTT assay
Acceptance criteria: ET-50 (4.77 - 8.72 h)
Result: 5.81 h
- Contamination: Longterm antibiotic and antimycotic free culture, no contamination observed
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the mean relative tissue viability with a test substance is less than or equal to 45 %.
- The test substance is considered to be non-irritant to skin if the mean relative tissue viability with a test substance is higher than 55 %.
- The test substance is considered to be borderline, if the mean relative tissue viability with a test substance is lesser than or equal to 55 % and higher then 45 %.
The „borderline"-evaluation (50 ± 5 %) was determined statistically using historic BASF data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 439. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 µL bulk volume of the solid test substance
NEGATIVE CONTROL
- Amount applied: 30 µL
POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5 % - Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 42 ± 4 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 109.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Yes, tissue 1
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Table 1: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance identification |
|
tissue 1 |
tissue 2 |
tissue 3 |
mean |
SD |
CV [%] |
NC |
mean OD570 |
* |
1.953 |
2.198 |
2.075 |
|
|
viability |
* |
94.1 |
105.9 |
100.0 |
8.3 |
8.3 |
|
16/0046-1 |
mean OD570 |
2.311 |
2.104 |
2.412 |
2.275 |
|
|
viability |
111.3 |
101.4 |
116.2 |
109.6 |
7.6 |
6.9 |
|
PC |
mean OD570 |
0.087 |
0.088 |
0.075 |
0.084 |
|
|
viability |
4.2 |
4.3 |
3.6 |
4.0 |
0.3 |
8.7 |
* Due to mechanical damage of tissue 1 during the washing procedure, only two tissues of the negative control could be evaluated. Since the OD570 values of tissue 2 and 3 are well within the historical control data, this deviation is not considered to adversely affect the result of this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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