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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 414-110-5 | CAS number: 1379678-96-2 ORASOL BLAU 761B
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD test guideline 486)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
- EC Number:
- 414-110-5
- EC Name:
- C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
- Cas Number:
- 1379678-96-2
- Molecular formula:
- UVCB Substance
- IUPAC Name:
- tetradecan-1-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Details on test material:
- - Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable
- Stability in solvent: at least 24 hours in PEG 400
- Storage: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Strain: Wistar/WU
Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
Number of animals: 25 males
Acclimatisation: at least 5 days
Age of the animals: 6-8 weeks old
Initial body weight at start of treatment: 274-357 g
Housing: single
Cage type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79312 Emmendingen 14, F.R.G.)
Bedding: granulated soft wood bedding (ALTROMIN, D-65931 Lage/Lippe, F.R.G.)
Feed: pelleted standard diet (ALTROMIN 1324, D-65931 Lage/Lippe, F.R.G.)
Water: tap water, ad libitum (Gemeindewerke, D-64380 RoBdorf, F.R.G.)
Environment:
Temperature: 21 ± 3 °C
Relative humidity: 30-70 %
Artificial light: 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- On the day of the experiment (immediately before treatment), the test item was formulated in PEG 400. The vehicle was chosen according to its relative non-toxicity for the animals. All animals were challenged orally once. The volume administered was 10 mL/kg bw.
- Details on exposure:
- The test item was formulated in PEG 400. This suspending agent was used as vehicle control. The test item was tested at the following dose levels:
2 hour treatment period: 2000 mg/kg bw
16 hour treatment period: 200 and 2000 mg/kg bw
The animals were starved overnight (2 hours treatment) or approximately 6 hours (16 hours treatment) before receiving the test item, water was available continuously. The animals received the test article once. Five animals (males) were treated per dose group.
After a treatment period of 2 or 16 hours, the animals were narcotised and sacrificed by liver perfusion. Primary hepatocyte cultures were established and exposed for 4 hours to 3HTdR (methyl-3H-thymidine) which is incorporated if UDS occurs. At least three cultures were established for each animal. - Duration of treatment / exposure:
- 2 or 16 hours
- Frequency of treatment:
- single treatment
- Post exposure period:
- After a treatment period of 2 or 16 hours, the animals were narcotised and sacrificed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2 hour treatment period: 2000 mg/kg bw ; 16 hour treatment period: 200 and 2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 2-Acetylaminofluorene in dimethyl sulfoxide/polyethylene glycol 400 (1+9): 100 mg/kg bw
Examinations
- Tissues and cell types examined:
- Primary hepatocyte cultures were established and examined.
- Details of tissue and slide preparation:
- Isolation of the Primary Hepatocytes
The animals were sacrificed by liver perfusion. After anaesthetising the rats with Nembutal (Sanofi/Ceva, D-40472 Düsseldorf, F.R.G.) the liver was perfused through the vena portae with Hanks' balanced salt solution (HBSS, Gibco/BRL, D-76344 Eggenstein, F.R.G.) supplemented with collagenase (0.05 % w/v, Boehringer Mannheim, D-68305 Mannheim, F.R.G.) adjusted to pH 7.4 and maintained at 37 °C. The hepatocytes were isolated from the liver and washed twice with HBSS. The crude cell suspension was filtered through a 94 µm stainless steel mesh to yield a single cell suspension. The quality of the actual performed perfusion was determined by the trypan blue dye exclusion method. In addition, the number of the isolated cells was determined.
Culture Conditions
The washed hepatocytes were centrifuged and transferred into Williams medium E (WME, Gibco/BRL, D-76344 Eggenstein, F.R.G.) supplemented (1) with HEPES (2.38 mg/mL), glutamin (0.29 mg/mL), penicillin (100 units/mL), insulin 0.50 µg/mL, streptomycin (0.10 mg/mL), fetal calf serum (100 µL/mL). The medium without the cells was adjusted to pH 7.6. At least three cultures were established for each animal. Aliquots of 2.5 mL with freshly isolated hepatocytes in complete culture medium (1.0 x 10E5 living cells/mL) were added to 35 mm six-well cluster dishes (Greiner, D-72603-Nurtingen, F.R.G.) containing one gelatinised 25 mm round plastic coverslip (Thermanox, Flow Laboratories, D-53340 Meckenheim, F.R.G.) per well.
After an attachment period of approximately 1.5 hours in a 95 % air/5 % carbon dioxide humidified incubator at 37 °C the culture medium was discarded. Then the cell layer was rinsed once with PBS to remove non-adherent cells. Subsequently 3HTdR (5 µCi/mL, specific activity 20 Ci/mmol; New England Nuclear, D-63033 Dreieich, F.R.G.) in 2.0 mL culture medium (WME, 1 % FCS) was added to the cultures. After a labelling time of 4 hous the cells were washed twice with WME supplemented with 1 % FCS and 0.25 mM unlabelled thymidine. Cultures were incubated overnight using the same medium. To prepare for autoradiography the medium was replaced by a hypotonic solution of 1 % sodium citrate for 10 minutes to swell the nuclei for better grain quantification. The cells on the coverslips were then fixed by three changes of methanol:acetic acid (3+1 v/v) for 20 min each, rinsed with 96 % ethanol, and air dried.
Autoradiographic processing
The cover slips were mounted the side carrying the cells up on glass slides and coated with KODAK NTB2 (Technomara, D-35463 Fernwald, F.R.G.) photographic emulsion in the dark. The coated slides were stored in light-proof boxes in the presence of a drying agent for 12-14 days at 4 °C. The photographic emulsion was then developed with KODAK D-19 (Technomara, D-35463 Fernwald, F.R.G.) at room temperature, fixed in TETENAL (Tetenal, D-22844 Norderstedt, F.R.G.) and stained with hematoxylin/eosin.
Quantification of UDS
Evaluation was performed microscopically on coded slides using NIKON microscopes with oil immersion objectives. The cells for scoring were randomly selected according to a fixed scheme. The number of silver grains above the nucleus was counted automatically using the ARTEK 880 or 982 counter. In addition, the number of grain counts of one nuclear-sized cytoplasm adjacent to the nucleus was counted. At least two slides per animal and 50 cells per slide were evaluated. Heavily labelled S-phase cells were excluded from counting. Four animals per group were evaluated as described above. - Evaluation criteria:
- Nuclear and net grain counts were estimated together. Increased net grains should be based on enhanced nuclear grain counts rather than on decreased cytoplasmic grain counts. A test item was classified as positive if the mean number of net grains was higher than 5 per nucleus at one of the test
points. A group average between 0 and 5 net grains was considered as a marginal response. A dose-related increase in nuclear and net grains and/or a substantial shift of the percentage distribution of the nuclear grain counts to higher values provided additional information to confirm a positive response with less than 5 net grains. Statistical significance gave further evidence for a positive evaluation. Statistical significance was evaluated by means of the nonparametric Mann-Whitney test. A test item producing net grains not greater than 0 at anyone of the test points was considered non-effective in this system. - Statistics:
- A statistical evaluation of the results was not necessary as the number of nuclear and net grain counts of the groups treated with the test item were in the range of the corresponding controls.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- but tested up to 2000 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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.