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EC number: 464-390-8 | CAS number: -
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 28, 2008 ~ Nov. 19, 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Everzol Red LF-B
- Molecular formula (if other than submission substance): C29H24ClN8O13S4 · 3Na
- Molecular weight (if other than submission substance): 925.21
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: mono constituent substance
- Physical state: Dark Purple Powder
- Analytical purity: 68.6%
- Impurities (identity and concentrations): see section 1.2
- Composition of test material, percentage of components: see section 1.2
- Isomers composition: see section 1.2
- Lot/batch No.: R4505504
- Expiration date of the lot/batch: Aug. 12, 2009
- Stability under test conditions: stable
- Storage condition of test material: 2~8 ℃
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Laboratory Animal Center, Taipei, Taiwan
- Age at study initiation: about 6 ~ 7 weeks
- Weight at study initiation: 22.0 ~ 25.3g
- Assigned to test groups randomly: yes, under the body weight basis
- Fasting period before study: no
- Housing: Male mice were housed up to five per cage in polycarbonate autoclavable cages with hardwood chip bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2℃
- Humidity (%): 50 ± 20%
- Air changes (per hr): 22
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: Oct. 28, 2008 To: Nov. 14, 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water for injection
- Justification for choice of solvent/vehicle: high solubility in water
- Concentration of test material in vehicle: 25, 50, 100 mg/mL
- Amount of vehicle (if gavage or dermal): 20 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
On each dosing day, appropriate weights of test article will be taken and dissolved in water for injection to make the concentrations of 25, 50 and
100 mg/kg
- Duration of treatment / exposure:
- Nov. 10, 11, and 12, 2008
- Frequency of treatment:
- once daily
- No. of animals per sex per dose:
- 5 males/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C;
- Justification for choice of positive control(s): laboratory historical data
- Route of administration: intraperitoneal injection
- Doses / concentrations: 1.0 mg/kg
Examinations
- Tissues and cell types examined:
- peripheral blood will be collected once in each animal of test article treated and negative control groups between 36 hours and 48 hours after the last treatment. Blood in the positive control will be sampled once approximately 48 hours after administration.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: dose-ranging finding test
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): between 36 hours and 48 hours after the last treatment
DETAILS OF SLIDE PREPARATION: The blood samples will be collected by the tail trimming and smeared on acridine orange-coated slides. The slides will be wrapped to protect from light and stored at 0 ~ 6℃ for at least 4 hours before scoring. A minimum of two slide will be prepared from each animal.
METHOD OF ANALYSIS: Fluorenscence microscope observation
- Evaluation criteria:
- Cytotoxicity evaluation: The quantification of the effect of the test article on erythropoiesis will be used as indicator of bone marrow toxicity, the proportion of erythropoiesis to total erythrocytes will be presented in each animal and every group. This ratio in the treatemnt groups should no be less than 20% of negative control.
The incidence of micronucleated reticulocytes per 1000 reticulocytes (MN/1000 RETs) will be presented for each animal and the mean ± SD will be expressed for each group. - Statistics:
- One-way ANOVA for comparisons of all data collected on the body weight for each treatment group and negative control.
U-test (Mann-Whitney Rank Sum test) for comparing treated group and negative control of frequencies of micronucleated reticulocytes.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Dose Levels of Everzol Red LF-B in Mice Micronucleus Assay
Group |
Dose Level |
Concentration |
Dose Volume |
No. of Mice |
Number |
(mg/kg) |
(mg/mL) |
(mL/kg) |
|
1 |
0 (Vehicle) |
0 |
20 |
5 |
2 |
500 |
25 |
20 |
5 |
3 |
1000 |
50 |
20 |
5 |
4 |
2000 |
100 |
20 |
5 |
5 |
1.0* |
0.05 |
20 |
5 |
*: Mitomycin C Vehicle: Water for injection
Table 2. The Effect of Everzol Red LF-B Treatment on Body Weights of BALB/c Mice
Treatment |
Dose |
No. of Mice |
Body Weight (g) Group Mean ± S.D. |
||||
(mg/kg) |
Day 1a |
Day 2a |
Day 3a |
Day 4 |
Day 5 |
||
Water for Injection |
0 |
5 |
23.5 ± 1.0 |
24.2 ± 0.9 |
24.5 ± 0.9 |
24.4 ± 1.1 |
24.7 ± 0.9 |
Test Article |
500 |
5 |
23.7 ± 0.9 |
24.4 ± 1.0 |
24.7 ± 1.2 |
24.8 ± 1.1 |
24.7 ± 1.1 |
1000 |
5 |
24.2 ± 1.1 |
25.1 ± 0.9 |
25.5 ± 0.9 |
25.5 ± 0.9 |
25.9 ± 1.3 |
|
2000 |
5 |
23.2 ± 0.8 |
23.8 ± 0.9 |
24.3 ± 0.9 |
24.6 ± 0.9 |
24.5 ± 0.9 |
|
Mitomycin C |
1.0 |
5 |
24.4 ± 0.3 |
25.2 ± 0.2 |
25.4 ± 0.3 |
25.3 ± 0.4 |
25.4 ± 0.4 |
a: Day 1, Day 2, and Day 3 were the days of dosing; all data were recorded immediately prior to dosing.
Table 3. Clinical Observations of Micronucleus Assay in BALB/c Mice for Everzol Red LF-B
Dose Level (mg/kg) |
Animal ID |
Day 1 a |
Day 2 a |
Day 3 a |
Day 4 |
Day 5 |
0 (Negative control) |
2080231019 2080231006 2080231007 2080231016 2080231015 |
all A01 |
all A01 |
all A01 |
all A01 |
all A01 |
500 |
2080231027 2080231012 2080231002 2080231011 2080231029 |
all X01 |
all X01 |
all X01 |
all A01 |
all A01 |
1000 |
2080231003 2080231005 2080231013 2080231020 2080231022 |
all X01 |
all X01 |
all X01 |
X01 A01 X01 A01 A01 |
all A01 |
2000 |
2080231028 2080231025 2080231030 2080231008 2080231009 |
all X01 |
all X01 |
all X01 |
X01 A01 A01 X01 A01 |
all A01 |
1b (Positive control) |
2080231014 2080231024 2080231023 2080231026 2080231004 |
all A01 |
all A01 |
all A01 |
all A01 |
all A01 |
a: Day 1, day 2 and Day 3 were the days of dosing, clinical observation was conducted after 5 hours dosing.
b: Mitomycin C 1 mg/kg
Key: A01 = Normal
X01 = Discolored feces (The color was similar to that of the test article)
Table 4. The Effect on the Percentages of Reticulocytes to Total Erythrocytes in BALB/c Mice Treated with Everzol Red LF-B
Dose (mg/kg) |
Individual Animal Data (% reticulocytes of 50,000 erythrocytes) |
Group Mean ± S.D. (% reticulocytes) |
||||
0 (Negative control) |
3.75 |
3.36 |
3.78 |
4.11 |
4.10 |
3.82 ± 0.31 |
500 |
3.38 |
4.11 |
4.33 |
4.05 |
3.27 |
3.83 ± 0.47 |
1000 |
3.79 |
3.73 |
5.03 |
3.67 |
5.09 |
4.26 ± 0.73 |
2000 |
3.21 |
3.70 |
3.58 |
3.41 |
3.45 |
3.47 ± 0.18 |
MMC (Positive control) |
1.74 |
2.26 |
1.80 |
1.72 |
1.61 |
1.83 ± 0.25 |
Table 5. The Effect on the Frequencies of Micronucleated Reticulocytes of BALB/c Mice Treated with Everzol Red LF-B
Dose (mg/kg) |
Individual Animal Data (MN/1000 RETs) |
Group Mean ± S.D. (MN/1000 RETs) |
||||
0 (Negative control) |
3, 0 |
3, 1 |
1, 0 |
1, 1 |
1, 2 |
1.3 ± 1.1 |
500 |
4, 0 |
0, 1 |
1, 1 |
0, 1 |
2, 1 |
1.1 ± 1.2 |
1000 |
0, 1 |
1, 2 |
0, 3 |
4, 1 |
2,1 |
1.5 ± 1.3 |
2000 |
1, 1 |
4, 0 |
1, 1 |
1, 2 |
0, 0 |
1.1 ± 1.2 |
MMC (Positive control)* |
36, 33 |
32, 29 |
42, 27 |
34, 33 |
41, 34 |
34.1 ± 4.7 |
*: The individual frequency of MN/1000 RETs was significantly higher than that of the negative control (p <= 0.05, U-test).
Table 6. Concurrent and Historical Control Values of the Frequencies of Micronucleated Reticulocytes in Mice
No. of MN/1000 RETs |
||
Negative Control* |
1.0 mg/kg Mitomycin C** |
|
Concurrent controls |
1.3 ± 1.1 |
34.1 ± 4.7 |
Historical control |
||
Mean ± S.D. |
1.5 ± 0.8 |
30.8 ± 6.4 |
Maximum |
4.0 |
45.5 |
Minimum |
0 |
15.0 |
*: Negative control: 0.5% CMC, water for injection, 1% CMC, sesame oil, PBS, 2% MC, 20% PEG in saline, 2% Tween 80 and soybean oil; concurrent negative control: water for injection
**: Mitomycin C was administered by i.p.
Historical control data recording period: Mar. 2003 to Oct. 2008
Negative control sample size = 261
Positive control sample size = 255
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
All criteria for a valid study as described in the protol were met. The results of the micronucleus ssay in BALB/c mice indicated that , under the conditions of this study, Everzol Red LF-B casused a negative response in mouse peripheral blood micronucleus assay.
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