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EC number: 942-803-7 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 27, 2020 to September 1, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfo-2-naphthyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts
- EC Number:
- 942-803-7
- Molecular formula:
- Not applicable; this UVCB substance contains: C31H21ClN7O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 804.0 < MW < 852.1 g/mol (UVCB substance), C31H22N7O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 785.5 < MW < 833.7 g/mol (UVCB substnace), and traces of NaCl and Na2SO4.
- IUPAC Name:
- 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfo-2-naphthyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: SPF (Beijing) biotechnology Co., Ltd.
- Age at study initiation: 51-61 days old
- Weight at study initiation: Males: 35.50-38.87 g; Females: 29.12-31.83 g
- Housing: The male mice were housed one per cage and the female mice were housed 3 or 5 per cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21.7-23.6 °C
- Humidity (%): 56-62 %
- Photoperiod: 12-hrs dark / 12-hrs light
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- Ultra-pure water (CAS No.: 7732-18-5)
- Frequency of treatment:
- Mice were administered twice by tail vein injection, with an interval of approximately 24 hours.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Remarks:
- for females
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- for males and females
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- for males and females
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- for males
- No. of animals per sex per dose:
- five males and five females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide monohydrate (CP, CAS No.: 6055-19-2)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Statistics results of the body weights in male and female mice
Sex |
Group |
Dose (mg/kg.bw) |
Animal number |
First Dosing (g) Mean±SD |
Last Dosing (g) Mean±SD |
Sacrifice (g) Mean±SD |
Male |
Negative control |
0 |
1000-1004 |
37.09 ± 0.98 |
36.08 ± 0.40 |
36.78 ± 0.57 |
Treated Group |
50 |
1100-1104 |
37.22 ± 0.91 |
36.31 ± 1.97 |
37.81*± 0.55 |
|
100 |
1200-1204 |
37.23 ± 0.83 |
37.02 ± 0.97 |
36.90 ± 0.95 |
||
200 |
1300-1304 |
37.30 ± 0.88 |
37.34 ± 0.36 |
37.01 ± 1.84 |
||
CP |
50 |
1400-1404 |
37.31 ± 1.07 |
36.01 ± 0.93 |
36.36 ± 1.44 |
|
Female |
Negative control |
0 |
2000-2004 |
30.35 ± 0.79 |
29.52 ± 1.12 |
30.06 ± 1.39 |
Treated Group |
25 |
2100-2104 |
30.47 ± 0.64 |
29.80 ± 0.71 |
28.75 ± 0.95 |
|
50 |
2200-2204 |
30.48 ± 0.69 |
29.48 ± 1.23 |
29.83 ± 1.10 |
||
100 |
2300-2304 |
30.48 ± 0.75 |
29.84 ± 0.70 |
29.59 ± 1.35 |
||
CP |
50 |
2400-2404 |
30.52 ± 0.84 |
29.14 ± 1.25 |
29.41 ± 1.47 |
Note: Statistically significant difference compared to negative control (*: P<0.05).
Table 2. Statistics results of microscopic analysis in mice
Sex |
Group |
Animal number |
Number of PCE |
MNPCE/PCE (‰) Mean±SD |
PCE/RBC Mean±SD |
Male |
Negative control |
1000-1004 |
20000 |
1.7± 0.7 |
0.60 ± 0.05 |
50 |
1100-1104 |
20000 |
1.7 ± 0.6 |
0.56#± 0.03 |
|
100 |
1200-1204 |
20000 |
1.8 ± 0.8 |
0.57#± 0.04 |
|
200 |
1300-1304 |
20000 |
1.6 ± 0.7 |
0.57#± 0.10 |
|
CP (50) |
1400-1404 |
20000 |
25.6**± 3.2 |
0.58 ± 0.05 |
|
Female |
Negative control |
2000-2004 |
20000 |
1.8 ± 0.6 |
0.60 ± 0.02 |
25 |
2100-2104 |
20000 |
1.6 ± 0.6 |
0.57#± 0.09 |
|
50 |
2200-2204 |
20000 |
1.6 ± 0.7 |
0.56#± 0.09 |
|
100 |
2300-2304 |
20000 |
1.7 ± 0.4 |
0.54#± 0.07 |
|
CP (50) |
2400-2404 |
20000 |
25.0**± 3.5 |
0.55 ± 0.05 |
Note: Statistically significant difference compared to negative control (**: P<0.01).
#: the ratio was more than 20 percent of the ratio in the negative control group.
Applicant's summary and conclusion
- Conclusions:
- According to OECD 474 test method, CJ306 was negative effect under the condition of in vivo mammalian somatic cell-erythrocyte micronucleus test.
- Executive summary:
This test using the procedures outlined in the SYRICI Study for G1980C0060 which is based on OECD 474 (OECD, 2016). The results of this OECD 474 test for CJ306 show that test validity criteria was met.
According to the results of the preliminary test, the maximum tolerated dose (MTD) for male mice were 200 mg/kg.bw/day and for female mice were 100 mg/kg.bw/day. Therefore, the three dose levels in female mice were 25, 50 and 100 mg/kg.bw/day, and the three dose levels in the male mice were 50, 100 and 200 mg/kg.bw/day. Comparing with the concurrent negative control group, the incidence of micronucleated PCE for the treated groups had no ststistically significant difference (P>0.05) and the incidence of micronucleated PCE for CP group had ststistically significant difference (P<0.01). Furthermoer, the ratios betweeen PCE and RBC in all treated groups were more than 20 percent of the ratio in the concurrent negative control group. Under the conditions of this study, the results of micronucleus test were negative. Therefore, CJ306 was not to induce the increase of the incidence of micronucleated PCE in mice.
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