Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 Acute Inhalation Toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
- Details on test material:
- 6.1. Test Item
6.1.1. Test Item Information
Identification K1600 black dye
Appearance Black powder
Batch G-152
Purity/Composition 99.03%
Test substance storage At room temperature
Stable under storage conditions until 31 December 2016 (retest date) (taken from label)
Study Specific Test Item Information
pH 8.6 at concentration of 20%
6.2. Vehicle Information
Solubility in vehicle:
• Water
20-23%
Stability in vehicle:
• Water
Stable
Stability for at least 6 hours at room temperature is confirmed
over the concentration range 20 to 200 mg/mL,
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat: Crl:WI(Han) (outbred, SPF-Quality)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- ca. 4 h
- Concentrations:
- The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration
(amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation
efficiency (ratio of actual and nominal concentration) was 23%. - No. of animals per sex per dose:
- 5 (five)
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- discriminating conc.
- Effect level:
- ca. 5.1 mg/L air (analytical)
- Based on:
- test mat.
- 95% CL:
- >= 4.95 - <= 5.25
- Exp. duration:
- 4 h
Any other information on results incl. tables
The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation efficiency (ratio of actual and nominal concentration) was 23%. The concentration was measured at time points (n=18) that were equally distributed over the exposure period, the results of which demonstrated that the item was sufficiently stable. The generation was interrupted on three occasions in order to remove test item deposits from the system. To compensate for these interruptions, the generation time was elongated by 4 minutes in order to achieve an actual exposure time of 240 minutes.
The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were
determined twice during the exposure period. The MMAD was 1.8 µm (gsd 2.1) and 1.4 µm (gsd 1.9).
Mortality
No mortality occurred.
Clinical Signs
No clinical signs indicating test item related toxicity were seen during and after exposure. Black and
blue staining by the test item of several body parts was seen throughout the observation period.
Body Weights
Overall body weight gain in males and females was within the range expected for rats of this strain
and age used in this type of study and were therefore considered not indicative of toxicity.
Macroscopic Findings
No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalatory LC50, 4h value of K1600 black dye in Wistar rats was established to exceed 5 mg/L
Based on these results K1600 black dye does not have to be classified and has no obligatory labelling
requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and
Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures
(including all amendments). - Executive summary:
The study was carried out based on the guidelines described in: - OECD Guidelines, Section 4, Health Effects. No.403, "Acute Inhalation Toxicity", Sep 2009. - Commission Regulation (EC) No 440/2008, B.2. Acute Toxicity (inhalation), L142, May 2008. - EPA OPPTS 870.1300, Acute inhalation Toxicity. EPA 712-C-98-193, August 1998. - JMAFF Guidelines (2000), including the most recent revisions. K1600 black dye was administered as an aerosol by nose-only inhalation for 4 hours to one group of five male and five female Wistar rats. Generation as a dust was technically not possible and therefore the test item was mixed with water and generated as a liquid aerosol. Mortality and clinical signs were observed daily during the observation period and body weights were determined on Days 1, 2, 4, 8 and 15. Macroscopic examination was performed after terminal sacrifice (Day 15). The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation efficiency (ratio of actual and nominal concentration) was 23%. The concentration was measured at time points (n=18) that were equally distributed over the exposure period, the results of which demonstrated that the item was sufficiently stable. The generation was interrupted on three occasions in order to remove test item deposits from the system. To compensate for these interruptions, the generation time was elongated by 4 minutes in order to achieve an actual exposure time of 240 minutes. The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were determined twice during the exposure period. The MMAD was 1.8 µm (gsd 2.1) and 1.4 µm (gsd 1.9). No mortality occurred. No clinical signs indicating test item related toxicity were seen during and after exposure. Black and blue staining by the test item of several body parts was seen throughout the observation period. Overall body weight gain in males and females was within the range as expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The inhalatory LC 50, 4h value of K1600 black dye in Wistar rats was established to exceed 5 mg/L. Based on these results K1600 black dye does not have to be classified and has no obligatory labelling requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.