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Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
EC number: 943-062-2 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- 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:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- Animals have been scarified prior to the treatment. This procedure represents an elevated testing conditions, because the intact skin barrier is destroyed.Therefore care must be taken to use results of these animals for the overall hazard assessment.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
- EC Number:
- 943-062-2
- Molecular formula:
- not available
- IUPAC Name:
- Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Code No: FAT 20036/D
Batch No: EN 91018.22
Stability: May 1987
Description: powder
Test Article Received: June 6, 1982
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 Kg
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAGf No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Individual identification: ear numbers
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod: 12 hours light cycle day
- Air changes: Approximately 15 air changes/h.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified on one side
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male and 3 female rabbits
- Details on study design:
- 24 hours before treatement the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each) and immediately before treatment, the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland.
Gauze patches soaked (or loaded) with 0.5 g of the test material 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 24 hours.
The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the following evaluation scheme.
SCORING SYSTEM:
Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score 4
Edema formation
- No edema 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- PRIMARY IRRITATION INDEX = 8.5 / 4 = 2.13
Any other information on results incl. tables
CALCULATION OF THE PRIMARY SKIN IRRITATION INDEX (TABLE 1)
The scores read after 24 and 72 hours for erythema and edema for the intact as well for the abraded skin were summed up and divided by 4 (FHSLA paragraph 191.11)
MEAN REACTION SCORE | |||||
Erythema | Edema | ||||
Time after exposure hours | Intact skin | Abraded skin | Intact skin | Abraded skin | |
24 | 1.5 | 1.0 | 1.3 | 1.0 | |
72 | 1.5 | 1.0 | 1.0 | 0.2 | |
Total | 3.0 | 2.0 | 2.3 | 1.2 | 8.5 |
PRIMARY IRRITATION INDEX =8.5 / 4 = 2.13
ASSESSMENT OF IRRITATION
- no irritation: 0
- minimal : 0.1-1.0
- slight : 1.1 -2.0
- moderate: 2.1-4.0
- marked: 4.1-6.0
- extreme: 6.1-8.0
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Conclusions:
- FAT 20036/D was concluded to be not a skin irritant.
- Executive summary:
FAT 20036/D was tested for skin irritation potential in a test performed on 3 males and 3 female New Zealand White rabbits. The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978. 24 hours prior to the treatment, the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each). Immediately before treatment, the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper". 0.5 g of the test material was applied to the prepared abraded and intact skin respectively. The skin reaction was assessed upon removal of test material patch and subsequently observed for a period of 7 days.
The exposure was found to have some irritation reactions on intact as well as abraded skin, however the scores did not meet the classification criteria as set by Regulation (EC) No. 1272/2008. The calculated primary irritation index was 2.13. Hence, under the conditions of the present experiment FAT 20'036/D wasconcluded to be not a skin irritant.
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