Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-487-8 | CAS number: 3115-68-2
- 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:
- From 16 November 2015 to 22 December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations sampled: all test concentrations, at t=0 and t=96h (but not all were measured)
- Sample storage conditions before analysis: in a freezer - Vehicle:
- no
- Details on test solutions:
- The test item was completely miscible in test medium at the concentrations tested. Preparation of test solutions started with the highest test concentration of 100 mg/L. No special treatment other than careful mixing was necessary to completely dissolve the test item in medium. Lower test concentrations were prepared by subsequent dilutions in test medium. The final test solutions were all 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
- Characteristics: F1 from a single parent-pair bred in UV-treated water
- Mean length at study initiation:
-- Range-finding test: 2.1 ± 0.1 cm
-- Final test: 2.1 ± 0.1 cm
- Mean weight at study initiation:
-- Range-finding test: 0.14 ± 0.05 g
-- Final test: 0.28 ± 0.06 g
ACCLIMATION
Acclimation period: At least 12 days after delivery
FEEDING
Daily with pelleted fish food (Essence (300-500 um), Coppens International bv, Helmond, The Netherlands).
FEEDING DURING TEST
No feeding for 24 hours prior to the test and during the total test period. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg CaCO3 per litre
- Test temperature:
- 20.8 - 21.4 °C
- pH:
- 7.3 - 7.9
- Dissolved oxygen:
- 6.7 - 9.4 mg/L
- Nominal and measured concentrations:
- - 10, 18, 32, 56 and 100 mg/L (nominal)
- Analysis of the samples taken from 100 mg/L at the start and the end of the final test showed that measured concentrations were stable and in agreement with nominal (96-105% relative to nominal) - Details on test conditions:
- TEST SYSTEM
- Test vessels: 6.5 litres, all-glass, containing 5 litres of test solution
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Loading: 0.39 g fish/L
TEST MEDIUM
Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3, formulated using RO-water (tap water purified by reverse osmosis; GEON Waterbehandeling, The Netherlands) with the following composition:
CaCl2.2H2O: 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3: 46.7 mg/L
KCL: 4.2 mg/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
Range finding study:
- Test concentrations: 0.1, 1.0, 10 and 100 mg/L (3 fish/concentration)
- Results used to determine the conditions for the definitive study:
No mortality was observed. The expected LC50 was above 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- (yearly sensitivity check using pentachlorophenol)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Analytically confirmed nominal test concentration
- Details on results:
- No mortality was observed in any of the test groups. Clinical effects were only observed at 100 mg/L at the end of the study and were limited to exophtalmus and a slightly darker colour.
- Results with reference substance (positive control):
- In the latest sensitivity check, performed in the period 4 - 8 January 2016, a 96h-LC50 of 0.24 mg/L was determined for carp exposed to pentachlorophenol. This is within the range observed during the past years.
- Sublethal observations / clinical signs:
Range-finding test:
Carp were affected from 24 hours onwards showing effects on swimming behaviour. These limited effects were mainly related to swimming at the top of the tank, snapping at the surface and head dominant swimming. Based on these results samples taken from nominal 10 mg/L were analysed. The measured concentration was stable and in agreement with nominal (105-107% relative to nominal).
Table 1: Mortality observed in the definitive test (none)
Concentration (mg/L, nominal)
Initial nb of fish
Mortality after 96 h
%Mortality
Control
7
0
0
10
7
0
0
18
7
0
0
32
7
0
0
56
7
0
0
100
7
0
0
Table 2: Nominal and measured concentrations
Concentration (mg/L, nominal)
Concentration (mg/L, measured, 0h)
Concentration (mg/L, measured, 96h)
Control
0.01
0.001
100
96
105
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a study performed in accordance with OECD 203 (1992) and according to GLP principles, an 96h-LC50 of >100 mg/L was determined, based on analytically confirmed nominal concentrations.
- Executive summary:
In a study performed in accordance with OECD 203 (1992) and according to GLP principles, the acute toxicity of the substance to carp was investigated. A final test was performed based on the results of a preceding range-finding test. Seven carp per test group were exposed to an untreated control and to nominal test item concentrations of 10, 18, 32, 56 and 100 mg/L. The total test period was 96 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. No mortality was observed in any of the test groups during the 96-hour test period. Analysis of the samples taken from 100 mg/L at the start and the end of the final test showed that measured concentrations were stable and in agreement with nominal (96-105% relative to nominal). The study met the acceptability criteria. Based on the results of the test, an 96h-LC50 of >100 mg/L was determined, based on analytically confirmed nominal concentrations.
Reference
Description of key information
In a study in accordance with OECD 203 (1992) and according to GLP principles, the acute toxicity of the substance to carp was investigated. A final test was performed based on the results of a preceding range-finding test. Seven carp per test group were exposed to an untreated control and to nominal test item concentrations of 10, 18, 32, 56 and 100 mg/L. The total test period was 96 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. No mortality was observed in any of the test groups during the 96-hour test period. Analysis of the samples taken from 100 mg/L at the start and the end of the final test showed that measured concentrations were stable and in agreement with nominal (96-105% relative to nominal). The study met the acceptability criteria. Based on the results of the test, an 96h-LC50 of >100 mg/L was determined, based on analytically confirmed nominal concentrations.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.