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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-544-3 | CAS number: 68123-13-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Basic Blue 991
- Author:
- Cosmetic Ingredient Review expert
- Year:
- 2 007
- Bibliographic source:
- International Journal of Toxicology, 26(Suppl. 2):51–63, 2007
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- In Vivo Absorption study of Basic Blue 99 in Sprague-Dawley rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- EC Number:
- 268-544-3
- EC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Cas Number:
- 68123-13-7
- Molecular formula:
- C19H20BrN4O2.Cl
- IUPAC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Reference substance name:
- Basic Blue 99
- IUPAC Name:
- Basic Blue 99
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Basic Blue 99- Molecular formula (if other than submission substance):C19H20BrN4O2•Cl- Molecular weight (if other than submission substance):451.75 g/mole- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):37 %
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- not specified
- Details on exposure:
- Rats were treated topically with 200 μl of an aqueous Basic Blue 99 (14C labeled) hair setting solution to assess its skin permeation potential. Approximately 31.3 μg Basic Blue 99/cm2 skin was applied at a volume of 0.2 ml over a 1.5 × 1.5-cm area on intact, clipped dorsal aspect of the thorax.
- Duration and frequency of treatment / exposure:
- 24 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:31.3 μg
- No. of animals per sex per dose / concentration:
- Three
- Control animals:
- not specified
- Positive control reference chemical:
- Data not available
- Details on study design:
- One hour later each rat was fitted with a collar to prevent licking the area of application. Urine and feces were analyzed 24 h after application.
- Details on dosing and sampling:
- Data not available
- Statistics:
- Data not available
Results and discussion
- Preliminary studies:
- Data not available
Main ADME results
- Type:
- absorption
- Results:
- very low percutaneous absorption.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Levels of 14C were low in the urine (< 0.02%) and feces (<0.07%) of two rats. The third rat excreted more than 5.05 % of 14C dose in urine, but only 0.12% in feces. Basic Blue 99 have very low percutaneous absorption.
- Details on distribution in tissues:
- Data not available
- Details on excretion:
- Data not available
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- Data not available
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Data not available
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsOn the basis of observed result it is concluded the Basic Blue 99 have very low percutaneous absorption and expected to have Low bio-accumulation potential based on study results.
- Executive summary:
In a in vivo Absorption study, three Sprague-Dawley rats were treated topically with 200 μl of an aqueous Basic Blue 99 (14C labeled) hair setting solution. Approximately 31.3 μg Basic Blue 99/cm2skin was applied at a volume of 0.2 ml over a 1.5 × 1.5-cm area on intact, clipped dorsal aspect of the thorax. Levels of14C were low in the urine (< 0.02%) and feces (<0.07%) of two rats. The third rat excreted more than 5.05 % of14C dose in urine, but only 0.12% in feces.Therefore, on the basis of observed result it is concluded the Basic Blue 99 have very low percutaneous absorption and expected to have Low bio-accumulation potential based on study results.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)