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EC number: 282-252-3 | CAS number: 84145-27-7
- 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:
- 2015-09-21 to 2015-11-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I14KB4717
- Expiration date of the lot/batch: 2016-11-25 (retest date)
- Purity test date: 2014-12-13 (certificate of analysis release date)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: no data - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples for possible analysis were taken form both test groups at the start of the test and after 72 hours from the freshly prepared solutions. At the first renewal (t=24h) and at the end of the test from the 24h old solutions. 2.0 mL of volume was taken
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
Range-finding test:
Based on the data provided by the Sponsor, the solubility of the test substance in water was 39.3 g/L. Therefore, the preparation of test solutions started with a loading rate of 100 mg/L (duplicate samples) applying a short period of magnetic stirring (47-51 minutes at room temperature) where after the solutions were hazy and contained flocks. These solutions were discarded. New solution was prepared in Milli-RO water (100 mg/L); after a 3-minute period of magnetic stirring the solution was clear and colourless confirming sufficient solubility of the test item in water. Subsequently salts were added to reach the concentrations described in paragraph 6.3 of the report (adjusted ISO medium) and used as the highest concentration. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions were all clear and colourless at the start of the test.
Due to appearance of undissolved material during the study and the decrease of the measured concentration in the highest treatment, it was concluded that the test item reacts with salts present in the medium. Therefore, it was decided, in consultation with the sponsor, to change the preparation
procedure in the final test.
Final test:
Based on the observations made in the range-finding test and in agreement with the sponsor, the solutions for the final test were prepared differently. A Saturated Solution (SS) was prepared at a loading rate of 100 mg/L (in duplicate) applying a one-hour period of magnetic stirring. The obtained mixture was filtered through a preconditioned membrane filter (RC55, Whatman). Filtrates originating from both replicates were combined and used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions were all clear and colourless at the start of the test.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All aqueous solutions were clear and colourless - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): range-finding test: 2.0 ± 0.1 cm, final test: 2.1 ± 0.1 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.16 ± 0.04 g, final test 0.13 ± 0.03 g
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% 7 days before test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- not reported
- Test temperature:
- 21.3-21.7°C
- pH:
- 7.0-7.7
- Dissolved oxygen:
- 7.0-9.3
- Salinity:
- not relevant
- Nominal and measured concentrations:
- Range-finder:
Nominal concentrations (mg/L): 0.1, 1, 10, 100 mg/L (samples from 10 and 100 mg/L were analysed)
Measured concentrations (mg/L) at t=0h: 11, 100
Measured concentrations (mg/L) at t=24h: 10, 81
Measured concentrations (mg/L) at t=96h: 10, 52
Final test:
Nominal concentrations (mg/L): 4.6, 10, 22, 46 and 100% of a SS prepared at 100 mg/L
Measured concentrations (mg/L) at t=0h: 0.0043, 3.96, 8.57, 18.8, 38.0, 85.1
Measured concentrations (mg/L) at t=24h: 37.9
Measured concentrations (mg/L) at t=96h: 0.0048, 3.94, 8.60, 18.8 - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5L, all-glass filled with 3L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
- Biomass loading rate: 0.30 g fish/L
OTHER TEST CONDITIONS
- Adjustment of pH: 7.7 ± 0.3
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent. In addition, fish that were convulsing or showing other severe forms of distress not considered transient in nature and likely to become more severe before the exposure is terminated, will be sacrificed for humane reasons. These fish will be treated as having died in the test, based on OECD guideline on humane endpoint (ENV/JM/MONO/(2000)7).
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 31 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% C.L.: 25-39 mg/L
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: Hypoactive, Discoloured and swimming at the surface, Loss of equilibrium - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.32 mg/L. the sensitivity of the fish was within the range determined with the historical data - Reported statistics and error estimates:
- The LC50 was determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations. Calculations were performed with ToxRat Professional v. 3.2.0. (ToxRat Solutions®, GmbH, Germany).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of T001202 to Carp was determined in a 96-hour static test according to the OECD guideline 203.
The 96-h LC50 was 31 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 25 and 39 mg/L) and was reached already after 24 hours of exposure. The results of the test can be considered reliable without restriction.
Reference
Description of key information
The study of Tobor-Kaplon (2016), investigating the acute toxicity of T001202 in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. The 96-h LC50 was 31 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 25 and 39 mg/L) and was reached already after 24 hours of exposure. The results of the test can be considered reliable without restriction.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 31 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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