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EC number: 274-386-6 | CAS number: 70209-87-9
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no untreated skin areas to serve as the control; amount applied on skin not provided, exposure period is of 24 h; smaller area of application (i.e., approx. 2.5 cm² gauze pad))
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- EC Number:
- 274-386-6
- EC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Cas Number:
- 70209-87-9
- Molecular formula:
- C32H21CrN10Na2O11S
- IUPAC Name:
- Disodium-[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-chromate(2-)
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): FAT 20060/B
- Substance type: Dye
- Analytical purity: Approx. 82 %
-Lot/batch No.: EN 78708
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: The animals were housed individually in metal cages
- Diet: NAFAG, Gossau SG, rabbit food (ad libitum)
- Water: ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature: 20±1 °C
- Humidity: 55±5 %
- Photoperiod: 10 h light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24, 48, 72 h, 4 and 7 d
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- PROCEDURE:
- The test was carried out according to the method given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) which is similar to the OECD Guideline 404.
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified.
- Gauze patches of 2.5 x 2.5 cm laden with the test substance were applied to the prepared abraded and intact skin.
- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 h exposure. The skin reaction was appraised upon removal during an observation period of 7 d.
SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth).
- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Test substance was found to cause a slight irritation when applied to intact and abraded rabbit skin.
The calculated primary irritation index was 1.7. - Other effects:
- none
Any other information on results incl. tables
Calculation of the primary skin irritation index:
Mean reaction score of 6 rabbits |
| ||||
Time after exposure (h) | erythema | edema | |||
intact skin | abraded skin | intact skin | abraded skin | ||
24 | 0.3 | 2.3 | 0.3 | 2.3 | |
72 | 0 | 0.83 | 0 | 0.83 | |
Total | 0.3 | 3.13 | 0.3 | 3.13 | 6.86 |
Primary irritation index = 6.86 : 4 = 1.7
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered to be not irritating to the skin.
- Executive summary:
An in vivo study was conducted to evaluate the skin irritation potential of the test substance (at ca. 82 % purity) in Himalayan rabbits according to the method given in the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), which is similar to OECD Guideline 404 with few deviations. The test substance was placed on a 2.5 cm² gauze pad which was then applied to abraded as well as intact skin of rabbits for 24 h under occlusive conditions. After the application period, the dressing was removed and the intact and abraded sites were assessed for oedema and erythema. A further assessment was made at 48, 72 h, 4 and 7 d. Very slight erythema as well as edema were observed in two rabbits at 24 h. These symptoms were fully reversible within 48 h. The primary irritation index was calculated to be 1.7. Under the study conditions, the test substance was considered to cause slight irritation which was fully reversible within 48 h when applied to intact and abraded rabbit skin. However, it does not meet the threshold criteria for classification for skin irritation as required by the Regulation (EC) No. 1272/2008 (CLP), hence considered to be not irritating to the skin.
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