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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Basic Blue 99
- Author:
- American College of Toxicology
- Year:
- 2 007
- Bibliographic source:
- International Journal of Toxicology, 26(Suppl. 2):51–63, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Developmental toxicity study have been carried out on rats to evaluate the effects of basic blue 99.
- 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
- Details on test material:
- - Name of test material (as cited in study report):Basic blue 99- Molecular formula (if other than submission substance):C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance):451.75- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):Purity-63%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- StrainPregnant Sprague-DawleyCD SexFemale
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- - M/F ratio per cage:No data- Length of cohabitation:No data- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.No data- Further matings after two unsuccessful attempts: [no / yes (explain)] No data- After successful mating each pregnant female was caged (how): No data
- Duration of treatment / exposure:
- Day 6th and 15th of gestation
- Frequency of treatment:
- once
- Duration of test:
- 50mg/kg/days
- No. of animals per sex per dose:
- 29
- Control animals:
- yes
- Details on study design:
- No data
Examinations
- Maternal examinations:
- Implantation sites ,resorptions
- Ovaries and uterine content:
- Yes
- Fetal examinations:
- The number of implantation sites, resorptions, living fetuses, and the number of corpora lutea were counted in each dam. The weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of thefetuses were recorded. One-third of the litter was examined for soft tissue anomalies and the remaining fetuses were examined for skeletal anomalies.
- Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Remarks on result:
- not measured/tested
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No teratogenic effects observed.The No oberved effect level was considered to be 50mg/kg as there
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: developmental toxicity No effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No oberved effect level was considered to be 50mg/kg as there
- Executive summary:
Developmental toxicity study have been carried out totest the effects of basic blue 99 on rats at the dose of 50mg/kg/day at 6th and 15th day of gestation .
No dams died or showed cumulative toxicity effect from the applied dose of 50 mg/kg Basic Blue 99. Test animals had no differences in mean body weight gain in the course of gestation as compared to controls. There were no treatment related effects. Basic Blue 99 at 50 mg/kg did not cause embryotoxic or teratogenic effects under the test conditions.
Therefore the No oberved effect level was considered to be 50mg/kg.
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