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EC number: 811-858-8 | CAS number: 2149571-68-4
- 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:
- 13 July 2015 - 16 Aug 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions.
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- EC Number:
- 811-858-8
- Cas Number:
- 2149571-68-4
- Molecular formula:
- C22 H11 N6 O18 S5 .5Na
- IUPAC Name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- Reference substance name:
- pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate
- IUPAC Name:
- pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): K1600 black dye
- Physical state: Powder, black
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: Between 12 and 24 weeks old
- Weight at study initiation: At least 1.5 kg.
- Housing: Individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C,
- Humidity (%): a relative humidity of 40 to 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 20-23%
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- 0.5g
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): Test substance was moistened with 0.4 mL of water.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4mL used to moisten the test substance. - Duration of treatment / exposure:
- Four hours after application.
- Observation period:
- 72 hours.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area, 150 square centimeters (10 x 15 cm)
- Type of wrap if used: metalline patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin cleaned of residual test substance using tap water and watery ethanol (50% v/v).
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
ERYTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness)* 4
* Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
OEDEMA FORMATION:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Animal 937
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Remarks:
- Animal 938
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Remarks:
- Animal 939
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Remarks:
- Animal 937
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Remarks:
- Animal 938
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Remarks:
- Animal 939
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- No skin irritation or corrosion was observed duirn the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results were evaluated according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments). No skin irritation was caused by 4 hours exposure to K1600 black dye.
- Executive summary:
Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study.
Three rabbits were exposed to 0.5 grams of K1600 black dye, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
The results were evaluated according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments). No skin irritation was caused by 4 hours exposure to K1600 black dye.
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