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EC number: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 21, 2015 to December 15, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Reaction products of 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt and lithium chloride
- Molecular formula:
- Not applicable; this UVCB substance contains: C25H14ClN10O16S5.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 940.9 < MW < 1021.1 g/mol (UVCB substance), and traces of NaCl.
- IUPAC Name:
- Reaction products of 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt and lithium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: 8-10 week old
- Housing: one or two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 20.2-22.1 °C
- Humidity (%): 41.0-68.4%
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- water for injection (WFI)
- Doses:
- Dose Step 1: 2000 mg/kg
Dose Step 2: 2000 mg/kg - No. of animals per sex per dose:
- Dose Step 1: three female
Dose Step 2: three female
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
Any other information on results incl. tables
Respectively, the mortalities and clinical observations in Dose Step 1 and 2 as below:
In Dose Step 1
No mortality occurred within the first three dayspost-dose. All dose animals tolerated the dose well and survived to termination on Day 15. For the first three days post dose, pilo-erection was noted for one animal (ID No. 0026) and mild decreased activity was noted for one animal (ID No. 0025). Abnormally colored mucus membrane (blue) was also noted for all three study animals on Day 1 through Day 8 and the signs for two animals (ID No. 0026 and 0027) persisted to Day 12. All study animals were seen to excrete blue colored feces for the first three days post dose. For two animals (ID No. 0025 and 0027), the blue colored feces had watery consistency with the first two to three days post dose. Two study animals (ID No. 0026 and 0027) were seen to excrete blue colored urine and the signs then persisted through the first three days. For all animals,blue stained hair over the ano-genital area, forepaws, hindpaws, and/or muzzle was noted in the first two or three days post dose. Butfor one animals(ID No. 0025), blue stained hair over the ano-genital area was noted from Day 1 through Day 12.
In Dose Step 2
All dose animals tolerated the dose well and survived to termination on Day 15. All study animals were seen to excrete blue colored feces for the first three days post dose and then one animal (ID No. 0030) persisted to seven days post dose. For two animals (ID No. 0028 and 0029), the blue colored feces had watery consistency with the first two to three days post dose.One animal (ID No. 0028) was also seen to have red stained hair at the nose in the first two days post dose and excretion of soft brown feces half an hour post dose. All study animals were seen to excrete blue colored urine. The signs for two animals (ID No. 0028 and 0029) and one animals (ID No. 0030) persisted through the first three days and seven days,respectively. For all animals,blue stained hair over the ano-genital area, forepaws, hindpaws, and/or muzzle was noted in the first two or three days post dose. There were no records of animal observations on Day 12 and Day 13.
In Dose Step 1 and 2, body weights increased throughout the study period and gross examination at termination revealed diffuse, dark brown discoloration in both kidneys of all study animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 423 test method a, the harmonized LD50 cut-off value of CJ309 was 5000 mg/kg. Therefore, CJ309 was Category 5 or Unclassified based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315005-GN which is based on the SOP for the OECD 423 and OECD 423 (OECD, 2002).A total of 6 female Sprague-Dawley rats were orally dosed with CJ309 in two dose steps of three animals each, at 2000 mg/kg b.w. for both Dose Step 1 and Dose Step 2. All animals in the two dose steps tolerated the test article well with increasing body weights and no mortality or moribundity reported. The only remarkable clinical signs observed were excretion of blue urine and feces within the first three to seven days post dose. Transient pilo-erection, decreased activity, and abnormally colored mucus membrane (blue) was also observed for some animals in either dose step. On the other hand, gross examination revealed dark brown discoloration of the kidneys of all study animals in both dose steps, suggestive of possible test article effect on the kidney at 2000 mg/kg b.w. or higher. In absence of mortality, moribund state, or other significant clinical and gross signs of toxicity, these results place CJ309 in the GHS Category 5 or Unclassified, with harmonized LD50 cut-off value at 5,000 mg/kg or Unclassified.
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