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EC number: 201-663-0 | CAS number: 86-30-6
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test performed according to OECD 203 testing guidelines, GLP compliant. The only deviation to the guidelines is the use of solvent, because the test item was considered insoluble. However, no mortality was recorded in the solvent control group.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- The only deviation is the use of a solvent, because the test item was considered insoluble. However, the solvent control group did not suffer any loss, which is considered to not impact the results. The experiment is therefore deemed as valid.
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- 0.75 mL of the test fluid was sampled from each of the test water tanks both before the start of testing and after 24 hours, and after the addition of 0.75 mL of acetonitrile, these were mixed well, and analysed by HPLC as analysis samples. During analysis of the test fluids, assay of a standard solution was performed for each specimen assay, and quantitated from the peak surface area ratio.
- Vehicle:
- yes
- Details on test solutions:
- 400 mg dimethylsulfoxide and a 1000 mg dispersal agent (HC0-30) were added to 400mg of the tested substance, and after being mixed and dissolved, the volume was set at 2000 mL with purified water, and this was treated as the test substance stock solution (200 mg/L concentration). For the adjuvant stock solution, 200mg dimethyl sulfoxide and 500 mg of the dispersal agent (HC0-30) were mixed and thereafter the volume was set to 1000mL using purified water.
For each concentration to be tested,after adding the above test substance stock solution according to the required final concentration, the adjuvant stock solution was added so that the adjuvant concentration was constant among each beaker. The control groups received the dilution water or the solvent containing dilution water only. - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- - Common Name: Orange Killfish
- Scientific name: Orzias Latipes
- Scale Length: 1.91 cm (1.68-2.13 cm), n=10
- Weight: 0.116 g (0.085-0.145 g), n = 10
- Supplier: Sankyo Aquaculture Center (1-1 Ban-chi, Ichidani-cho, Shinjuku Ward, Tokyo)
- Delivery Date: November 1, 1996
- Acclimation period: November 1, 1996 - February 3, 1996
Bred and domesticated under the same conditions (water quality, temperature, etc.) as the test conditions. Commercial Tetramine® was given for feed. No feeding was performed from 24 hours prior to exposure. Normal specimens that were grossly healthy were used in the testing. The mortality rate for the 7 days prior to the start of exposure was 5% or less. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Hardness:
- 61 mg equivalent CaCO3
- Test temperature:
- 23.2 - 24 °C (min-max)
- pH:
- 7.4-7.8 (min-max)
- Dissolved oxygen:
- 5.9-8.4 (min-max) , always >60% saturation
- Salinity:
- 12 mg/L sodium
- Nominal and measured concentrations:
- - Nominal concentrations: 2 ; 3.8 ; 7.4 ; 14 ; 28 mg/L
- Measured concentrations (geometrical means): 2.07 ; 3.99 ; 7.65 ; 15.3 ; 31.6 mg/L
- Deviations from nominal concentrations did not exceed 20% throughout the experiment. Therefore, nominal concentrations were used for statistical analysis - Details on test conditions:
- - Exposure Form: Semi-static method with 5-L glass beakers (The entire volume of test fluid was replaced every 24 hours. In addition, the surface of the water was covered with a Teflon shield in order to prevent the volatization of the tested substance from the water).
- Exposure Period: 96 hours
- Test fluid volume: 5.0 L
- Number of replicate: 1 container per concentration group
- No. of organisms: 10 perconcentration group
- Aeration: None
- Test water temperature: 24±1°C
- Illumination: Room light, 16L:8D
- Feeding: No feeding - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 10.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- The 96-hour median lethal concentration was 10.2mg/L. Furthermore, the mortality rates of the control plot and the adjuvant control plot were 0%.
- Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- The mortality rate (%) was calculated from the number of dead bodies in each concentration group and the number of test organisms (10), and the median lethal concentration (LC50) was calculated by the binomial method.
- Sublethal observations / clinical signs:
Cumulative mortality:
Control: 0%
Solvent control: 0%
2 mg/L: 20%
3.8 mg/L: 0%
7.4 mg/L: 0%
14 mg/L: 100%
28 mg/L: 100%
- Validity criteria fulfilled:
- yes
- Conclusions:
- Oryzias latipes were exposed to a graded series of N-nitrosodiphenylamine concentrations for 96 hours. The estimated LC50 was 10.2 mg/L.
- Executive summary:
Oryzias latipes were exposed to a graded series of N-nitrosodiphenylamine concentrations (control; solvent control ; 2 ; 3.8 ; 7.4 ; 14 ; 20 mg/L) for 96 hours, according to the OECD 203 guidelines. The only deviation to these guidelines was the use of a solvent to dissolve the test-item, considered as insoluble. However, the control solvent did not cause any mortality. Measured concentrations did not differ from the nominal concentrations by more than 20%. Therefore, nominal concentrations were used for statistical analysis. The estimated LC50 after 96 hours exposure is 10.2 mg/L
Reference
Description of key information
96-h LC50 of fish was estimated to be above 10.2 mg/L by Mitsubishi (1997). In a second study, they found a 7-d LC50 of 8.9 mg/L and a 14-d LC50 of 4.9 mg/L, with a 14-day NOEC of 3.3 mg/L. These data are together consistent. The study of Buccafusco was disregarded because the test-item formed a precipitate within the test system and oxygen concentration dropped to 0.3 mg/L far beneath acceptable limits. LC50 found by Buccafusco was 5 mg/L.
The 96-h LC50 value will be retained for risk assessment since it is compliant with the guidance on information requirements and chemical safety assessment Chapter R10: characterisation of dose [concentration]-response for environment (2008).
Fish LC50 = 10.2 mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 10.2 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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