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EC number: 223-339-8 | CAS number: 3844-45-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
Data source
Reference
- Reference Type:
- publication
- Title:
- The comet assay with 8 mouse organs: results with 39 currently used food additives
- Author:
- Yu F. Sasaki, Satomi Kawaguchi, Asako Kamaya, Miyuki Ohshita, Kazumi Kabasawa, Kayoko Iwama, Kazuyuki Taniguchi, Shuji Tsuda
- Year:
- 2 002
- Bibliographic source:
- Mutation Research 519 (2002) 103-119
Materials and methods
- Principles of method if other than guideline:
- Comet assay with 8 organs in mice
- GLP compliance:
- no
- Type of assay:
- other: Comet-assay
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- EC Number:
- 223-339-8
- EC Name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- Cas Number:
- 3844-45-9
- Molecular formula:
- C37 H34 N2 Na2 O9 S3
- IUPAC Name:
- disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)benzenesulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test substance: Brilliant Blue FCF
Test substance: Neptune Blue BRA concentrate
Constituent 1
- Specific details on test material used for the study:
- Identity: Brilliant Blue FCF, CAS 3844-45-9, Colour index CI-42090
-supplier: Tokyo Kasei Kogyo Industry Ltd, Tokyo, Japan;
Test animals
- Species:
- mouse
- Strain:
- other: ddY mice
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Co., Shizuoka, Japan
- Age at study initiation: 7 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- physiological saline
- Duration of treatment / exposure:
- Single treatment, sacrifice after 3h and 24h
- Frequency of treatment:
- single treatment
- Post exposure period:
- 3 and 24h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- The study did not include an established positive control. Positive findings were reported for a number of the 39 tested food additives.
Examinations
- Tissues and cell types examined:
- Stomach, Colon, Liver, Kidney, Bladder, Lung, Brain, Bone marrow
- Details of tissue and slide preparation:
- The liver, kidney, Jung, and brain were minced, suspended in 4 ml chilled homogenizing solution (pH 7 .5) containing 0.075 M NaCI and 0.024 M Na2EDTA, and then homogenized gently using a Potter-Elvehjem type
homogenizer at 500-800 rpm, in ice.
The glandular stomach, colon, and urinary bladder were opened and rinsed with physiological saline; the mucosa was scraped into 4 ml chilled homogenizing buffer and homogenized gently using a Potter-Elvehjem type
homogenizer at 500-800 rpm, in ice. To obtain nuclei, the homogenate was centrifuged at 700 x g for 10 min at 0 °C, and the precipitate was re-suspended in chilled homogenizing buffer at 1 g organ weight/ml.
Seventy-five microliters agarose GP-42 was quickly layered on a slide (Matsunami Glass Ind. Ltd., Osaka, Japan) coated with agarose GP-42 and covered with another slide. The slide sandwiches were placed horizontally to allow the agarose to solidify. The nucleus suspension was mixed 1: 1 (v/v) with 2%, 45 °C, agarose LGT, and 75 μ! of the nucleus mixture was quickly layered in the same manner after removal
The length of the whole comet ("length") and the diameter of the head ("diameter") were measured for 50 nuclei per organ
per animal. We calculated migration as the difference between length and diameter for each of 50 nuclei.
Mean migration of 50 nuclei from each organ was calculated for each individual animal. - Evaluation criteria:
- An increase in DNA damage was indicated by a statistically significant increase in DNA migration
- Statistics:
- The differences between the averages of four treated animals and the untreated control animals were compared with the Dunnett test after one-way ANOVA. A P value less
than 0.05 was considered statistically significant.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- other: Positive findings were observed for other substances in this study.
Any other information on results incl. tables
Migration (μm, mcan ± S.E.M. of four animals) |
Time after dosing | stomach | colon | liver | kidney | bladder | lung | Brain | Bone marrow | |
control | - | 5.71 ± 0.52 | 5.42 ± 0.87 | 2.35 ± 0.49 | 2.27 ± 0.62 | 5.45 ± 0.74 | 2.84 ± 0.19 | 0.95 ± 0.36 | 1.23 ± 0.45 |
2000 mg/kg bw | 3h | 4.03 ± 0.60 | 3.49 ± 1.56 | 5.39 ± 1.36 | 4.63 ± 0.88 | 4.57 ± 0.97 | 4.62 ± 0.54 | 2.14 ± 0.98 | 0.65 ± 0.44 |
2000 mg/kg bw | 24h | 5.75 ± 0.96 | 4.77 ± 1.85 | 1.09 ± 0.97 | 5.27 ± 1.35 | 5.21 ± 0.81 | 4.25 ± 1.90 | 2.50 ± 1.18 | 4.57 ± 1.35 |
Applicant's summary and conclusion
- Conclusions:
- A single treatment of mice with 2000 mg/kg bw did not result in DNA damage as indicated by comet formation.
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