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EC number: 942-667-9 | 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:
- dilithium(1+) sodium 7-[(1E)-2-{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazen-1-yl]naphthalene-1,3,6-trisulfonate
- EC Number:
- 942-667-9
- Molecular formula:
- Not applicable; this UVCB substance contains: C20H13ClN9O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 691.8 < MW < 739.9 g/mol (UVCB substance), C20H14N9O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 673.4 < MW < 721.5 g/mol (UVCB substnace), and traces of NaCl.
- IUPAC Name:
- dilithium(1+) sodium 7-[(1E)-2-{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazen-1-yl]naphthalene-1,3,6-trisulfonate
- 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
- 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.
Any other information on results incl. tables
Respectively, the mortalities andclinical 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. Two animals (ID No. 0032 and 0033) were seen to have mild decreased activity in the first three days post dose. Two animals (ID No. 0031 and 0033) excreted orange colored urine and then no abnormal excretion was reported after Day 3. Hair loss of the forelimb was noted for one animal (ID No. 0031) on Day 6 and persistent to study completion.
In Dose Step 2
All dose animals tolerated the dose well and survived to termination on Day 15. Two animals (ID No. 0034 and 0036) excreted orange colored urine and then two animals (ID No. 0034 and 0035) excreted red colored feces. No abnormal excretion was reported after Day 3. Red stained hair over the ano-genital area was noted for one animal (ID No. 0034) on Day 1 through Day 3. 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 no remarkable changes or lesions in all dose animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- or Unclassified
- Conclusions:
- According to OECD 423 test method a, the harmonized LD50 cut-off value of CJ312 was 5000 mg/kg. Therefore, CJ312 was Category 5 or Unclassified based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315006-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 CJ312 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 mild decrease in activity in the first three days post dose in Dose Step 1; and excretion of orange urine in both dose steps and red feces in Dose Step 2, both within the first three days post dose. Isolated instances of forelimb hair loss were also noted for one animal in Dose Step 1. In absence of mortality, moribund state, or other significant clinical and gross signs of toxicity, these results place CJ312 in the GHS Category 5 or Unclassified, with harmonized LD50 cut-off value at 5,000 mg/kg or Unclassified.
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