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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 April 2015 - 08 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed at a GLP laboratory in accordance with OECD, EU and US testing guidelines for the assessment of skin sensitization.
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- A deviations in the daily mean relative humidity and a procedural deviation during the pre-screening test occured. The study integrity was not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- A deviations in the daily mean relative humidity and a procedural deviation during the pre-screening test occured. The study integrity was not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- A deviations in the daily mean relative humidity and a procedural deviation during the pre-screening test occured. The study integrity was not adversely affected by the deviations.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 and 206474/A
- Physical state: Powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approx. 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Group housed in labeled Makrolon cages containing sterilised sawdust as bedding material
- Diet: Free access to pelleted rodent diet
- Water: Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): 10
- Photoperiod: 12-hour light/12-hour dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- Pre-screening & main study: 0 (control, vehicle only) 10, 25 or 50% w/w
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- Pre-screening & main study: 0 (control, vehicle only) 10, 25 or 50% w/w
- No. of animals per dose:
- Pre-screening study: 2 animals per concentration
Main study: 5 animals per concentration
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0 (Vehicle only), 10, 25 and 50 % (w/w)
- No. of animals per dose:
- Pre-screening study: 2 animals per concentration
Main study: 5 animals per concentration - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: There was no information available regarding the solubility or stability in vehicle.
- Irritation: No irritation and no signs of systemic toxicity were observed in any of the pre-screen animals.
- Lymph node proliferation response: Not performed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth): 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema: 4
TREATMENT PREPARATION AND ADMINISTRATION:
Pre-screening: Each animal was treated with one concentration on three consecutive days.
Main study (induction): Each animal was treated with one concentration on three consecutive days. The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance, at approximately the same time on each day.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI values calculated for the substance concentrations 10, 25 and 50% were 3.7, 4.9 and 17.9, respectively. These results show that the test substance elicits a SI ≥ 3. The EC3 value (the estimated test substance concentration that will give a SI =3) was established to be between 0 and 10%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 2293, 3072 and 11192 DPM, respectively. The mean DPM/animal value for the vehicle control group was 627 DPM.
Any other information on results incl. tables
DEVIATIONS
1. Deviations from the maximum level of daily mean relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations.
2. Following cleaning of the ears on Day 2 of the pre-screentest, the animals were dosed before scoring for erythema, instead of after. Evaluation: The test substance remnants after dosing did not hamper scoring of the ears therefore the ears could be scored according to the standard procedure (without cleaning of the ears). The purpose of the pre-screen test is to select the highest concentration for the main study.
The main study results showed that the right concentration was selected. The study integrity was not adversely affected by the deviations.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Skin Sens. 1 Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was determined to be classified as Skin Sens. 1 in accordance with Regulation (EC) No 1272/2008.
- Executive summary:
The sensitising potential of the test substance was examined in accordance with the test guidance provided in EC, No 440/2008; B42, OECD 429 and EPA, OPPTS 870.2600. The study was performed in a GLP compliant laboratory, minor deviations were observed but were determined not to affect the validity of the study. The test substance was determined to be classified as Skin Sens. 1 in accordance with Regulation (EC) No 1272/2008.
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