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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 481-170-7 | CAS number: 502453-61-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Acute oral toxicity has been estimated from a dose selection experiment preceeding an in-vivo Comet assay.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study was performed according to internationally accepted protocol for the in vivo Comet assay (A Hartmann et al, 2003)
- GLP compliance:
- yes
- Test type:
- other: In vivo mammalian cell study : DNA damage and/or repair
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 481-170-7
- EC Name:
- -
- Cas Number:
- 502453-61-4
- Molecular formula:
- Hill formula: C23H30BrN3O2 CAS formula: C23H30N3O2.Br
- IUPAC Name:
- dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide
- Details on test material:
- - Name of test material (as cited in study report): B119 HC Blue 16
- Molecular formula (if other than submission substance): C23H30N3O2Br
- Molecular weight (if other than submission substance): 460.42
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Active
- Physical state: Solid, dark blue powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:WI BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 6-8 weeks of age
- Weight at study initiation: 152-203 g
- Assigned to test groups randomly: Yes; Animals were randomized according to randomization numbers generated by a computer program created and validated in house.
- Fasting period before study: Food withdrawn prior to weighing at the start of the pilot and main studies, 4-5 hours before the first treatment and were given food again 1 hour after treatment
- Housing: Individually in Makrolon type IIA cages
- Diet (e.g. ad libitum): Fixed- formula feed "Maus/Ratte Haltung (NAFAG 9441), 3883.0.15" for mice and rats, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5-23.0 °C
- Humidity (%): 41-52%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: N/A To: N/A
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Deionised water
- Details on oral exposure:
- Single administration
- Doses:
- 100, 200, 400, 600, 2000 mg/kg bw
- No. of animals per sex per dose:
- Three
- Control animals:
- no
- Details on study design:
- Range finding study to determine maximum tolerated dose levels preceeding an in-vivo Comet assay.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 600 - < 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
- Dose range: Initially 2000 mg/kg bw was administered which caused the rats to die shortly after administration so another range finding study was conducted using doses of 100 and 200 mg/kg bw. Since the maximum tolerated dose was not reached another range finding study was conducted at levels of 400 and 600 mg/kg bw.
- Clinical signs of toxicity in test animals: Roughened fur, rapid breathing, twitching at the 100 and 200 dose levels. At the 400 mg/kg dose level, rats were observed with roughened fur, rapid breathing, and discolored feces. At the 600 mg/kg bw dose level, rats were observed with roughened fur, rapid breathing, palmospasms, discolored feaces and langour. Based on these results 600 mg/kg bw was selected as maximum tolerated dose for this test in male rats.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 (rat) was estimated to be in the range of >600-<2000 mg/kg bw.
- Executive summary:
In a dose selection experiment preceeding an in-vivo Comet assay three animals receiving 2000 mg/kg bw of the test substance died whereas a dose of 600 mg/kg bw was found to be the maximum tolerated dose. The oral LD50 (rat) was estimated to be in the range of >600-<2000 mg/kg bw.
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.