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EC number: 210-431-8 | CAS number: 615-50-9
- 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
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 11, 2010 to June 20, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, followed guideline, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to OECD, EC and German principles of Good Laboratory Practice
Test material
- Reference substance name:
- 2-methyl-p-phenylenediamine sulfate
- EC Number:
- 210-431-8
- EC Name:
- 2-methyl-p-phenylenediamine sulfate
- Cas Number:
- 615-50-9
- Molecular formula:
- C7H10N2.H2O4S
- IUPAC Name:
- 2-methylbenzene-1,4-diamine; sulfuric acid
- Reference substance name:
- HAARBRAUN
- IUPAC Name:
- HAARBRAUN
- Reference substance name:
- toluene-2,5-diamine sulfate
- IUPAC Name:
- toluene-2,5-diamine sulfate
- Details on test material:
- - Name of test material: Toluene-2,5-diamine sulfate; Haarbraun (TSIN # 23005)
- Substance type: Pure active substance
- Physical state: White to light pink powder
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature, protected from moisture and light
- Solubility: 5.03 g/L
Constituent 1
Constituent 2
Constituent 3
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 0.625, 1.25, 2.50, 5.00, 10.0 mg/L (all test concentrations)
- Sampling method: All test concentrations were sampled daily (until 100% mortality occurred).
- Sample storage conditions before analysis: All samples were analysed directly after sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Preparation: Stock solutions were prepared in HPLC water. For the test concentrations of 0.625 and 1.25 mg/L, stock solutions of 1.56 and 3.10 g/L were prepared. For the test concentrations of 2.5 to 10 mg/L, stock solutions of 5.00 g/L were prepared.
- Application of test solution: A flow-through exposure design was carried out. The stock solutions with different concentrations were introduced using precision syringe pumps. The dilution water was split in 6 separate streams. The stock solutions were mixed in a mixing chamber by magnetic stirring before passing the aquaria.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Strain: Not reported
- Source: Niedersachsischer Landesbetrieb fur Wasserwirtschaft, Kusten- und Naturschutz, An der Scharlake 39, D-31135 Hildesheim. All fish used in the test were gained at Dr. U. Noack Laboratorien from a single brood stock.
- Age at study initiation: Not reported
- Length at study initiation: 2.24 cm
- Weight at study initiation: 0.180 g
- Feeding during test: No
HOLDING CONDITIONS (Performed at test facility)
- Temperature: 23 ± 2°C
- Light intensity: Diffuse light (0.1 - 10 µmol photons x m (2) x s (1), natural photoperiod).
- Food: Dry food sera vipan SERA GMBH, D-52518 Heinsberg. The amount of food was 4% of the fish body weight per feeding day.
- Feeding frequency: 3 times per week
- Water (maintenance): Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. The water was analysed biannual according to German tap water regulation. Nominal water parameters were:
Total hardness: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
Dissolved oxygen: >80% of the air saturation value
- The water was changed at least once per week.
- Health: No disease treatments were administered throughout holding.
ACCLIMATION
- Acclimation period: At least 12 d
- Acclimation conditions: The same water was used for holding and testing of fish.
- Type, frequency and amount of food: See description of holding above.
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
Test conditions
- Hardness:
- 60.5 mg/L as CaCO3 (Measured by Spectrophotometer: DR 5000, HACH LANGE). The values were within the acceptable limits.
- Test temperature:
- 22.8 - 23.5 C (Measured by Data Logger: 175-T3, TESTO (for continuous measuring)). The values were within the acceptable limits.
- pH:
- 7.38-8.70 (Measured by HQ40d multi, HACH). The values were within the acceptable limits.
- Dissolved oxygen:
- 100% (Measured by HQ40d multi, HACH) The values were within the acceptable limits.
- Nominal and measured concentrations:
- Nominal test concentrations: 0, 0.625, 1.25, 2.50, 5.00 and 10.0 mg/L
Measured concentrations (geometric mean): 0, 0.553, 1.07, 2.21, 4.43 and 8.85 mg/L. The measured concentrations were 83 - 95% of the nominal concentrations throughout exposure, therefore the results were based on nominal concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass-aquaria loosely covered by glass tops
- Type: Open
- Material, size, headspace, fill volume: Each glass aquaria contained about 7 L of test medium.
- Aeration: No (the test was a flow-through design)
- Type of flow-through: Membrane piston pumps provided the water flow-through. The dilution water was split into 6 separate streams. Precision syringe pumps introduced appropriate volumes of stock solutions with different concentrations. The stock solutions were mixed in a mixing chamber by magnetic stirring before passing the aquaria.
- Equilibration period: An equilibration period of 5 d was carried out prior to exposure. The nominal test concentrations were analytically measured during the equilibration period. Details are provided in the study report (Table 10).
- Renewal rate of test solution: 20 times/d corresponding to flow rate of 5.28-5.76 L/h
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 1 fish/0.7 L
- Fish density in the vessel: < 1 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Same tap water was used for holding and testing. Detail of holding water is provided under ‘Details on test organisms’ section above.
- Intervals of water quality measurement: pH-value, temperature and oxygen saturation were measured daily in all vessels after start of exposure and every 24 h. Total hardness of the water was determined at test start. During the test the water temperature was recorded continuously in the control aquarium with a data logger. The flow rates of the test media were checked daily.
OTHER TEST CONDITIONS
- Photoperiod: 12 h light/12 h dark
- Light intensity: 0.01 - 0.04 µmol photons x m (-2) x s (-1). Dimmed light was used with regard to the test material properties.
EFFECT PARAMETERS MEASURED: Fishes were observed after 24, 48, 72 and 96 h for the following endpoints:
1. Mortality (evident by no visible movement and if touching of the caudal peduncle produced no reaction)
2. Visible abnormalities (e.g. loss of equilibrium, swimming behavior, respiratory function, pigmentation etc).
3. Mean body weight of fish (at the end of exposure)
4. Mean total length of fish (at the end of exposure)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: A 96 h non-GLP range finding test under flow-through conditions was carried out with five fish/concentration.
- Test concentrations: 0, 0.1, 1.0 and 10.0 mg/L
- Results used to determine the conditions for the definitive study: Yes. Following results were observed in the range finding study:
1. Mortality: 100% mortality was observed in 10.0 mg/L dose level within 24 h of exposure. No mortality was observed in any of the remaining test concentration throughout the range finding study.
2. Behaviour: All the test organisms exposed with a concentration of 1.0, 0.1 and control exhibited normal behaviour throughout the range finding study.
Details on range finding study is provided in the study report. - Reference substance (positive control):
- not required
Results and discussion
Effect concentrations
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.08 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 0.799 - 1.44 mg/L
- Details on results:
- - Mortality in test groups: Refer to 'Table 2' under 'Any other information on results incl. tables' section.
- Behavioural abnormalities: Slowed escape reflex, laying on the back, lethargy, no escape reflex, staggering, arresting on the ground were observed in fish at concentrations above 0.625 mg/L. Details on biological data at 24, 48, 72 and 96 h for different concentrations are provided in the study report (Table 5).
- Observations on body length and weight: Mean body weight: 0.178 g; Mean total length: 2.12 cm (ranged from 1.20 - 2.90 cm)
- Mortality of control: 0%
- Any observations that might cause a difference between measured and nominal values: No.
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- The LC50-values and corresponding 95% confidence intervals were calculated after 24, 48, 72 and 96 h from the nominal test material concentrations using probit analysis (EPA probit analysis program, version 1.5).
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 2: Cumulative Mortality (%) in the Test Vessels (Study # 66992)
Nominal concentration of Haarbraun (mg/L)
Test Duration (h)
24
48
72
96
10.0
100
100
100
100
5.00
100
100
100
100
2.50
70
100
100
100
1.25
10
40
60
60
0.625
0
10
10
10
Control
0
0
0
0
Study # 66992: Acute toxicity of Haarbraun (615 -50 -9) to Danio rerio.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 hr LC50 of Toluene-2,5-diamine sulfate (Haarbraun) to Danio rerio (Zebrafish) was 1.08 mg/L. The result is based on nominal concentration (measured concentrations were 83-95% of nominal throughout the flow-through study).
- Executive summary:
The 96 h acute toxicity study of Toluene-2,5-diamine sulfate (Haarbraun) to Danio rerio (Zebrafish) was determined under flow through conditions, following the OECD guideline 203 for fish acute toxicity test.
The nominal test concentrations were: 0, 0.625, 1.25, 2.50, 5.00 and 10.0 mg/L. Measured concentrations were 83 -95% of nominal throughout the test, and therefore results are based on nominal concentrations. Measured concentrations (geometric mean) were: 0, 0.553, 1.07, 2.21, 4.43 and 8.85 mg/L.
10 test organisms in single replicates were exposed to each test concentration and control. The dilution water was tap water (filtered, dechlorinated) of 60 mg/L hardness (as CaCO3).
The 96 h LC50 of Toluene-2,5-diamine sulfate (Haarbraun) to Danio rerio (Zebrafish) was 1.08 mg/L, based on nominal test concentration.
This acute toxicity test is classified as acceptable and satisfies the guideline requirement for the OECD 203.
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