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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- 31 October 2011 to 16 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- 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)
- 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.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Principles of method if other than guideline:
- -
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Stability in water: Not indicated
Solubility in water: ≤24.5 ng/L at 20 °C (determined in NOTOX project 497887) - Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control according to the schedule below. In addition, the filter was kept for possible analysis of undissolved residue.
Frequency: at t=0 h and t=96 h
Volume: 1 ml from the approximate centre of the test vessels
Storage: Samples were stored in a freezer until analysis.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Additionally, reserve samples of 1 ml were taken for possible analysis. - Vehicle:
- no
- Details on test solutions:
- The batch of FAT 41043/A tested was a red powder, solid with a purity of 99.8 % and consisted of two isomeric forms. The substance was not completely soluble in test medium at the loading rate initially prepared.
Preparation of test solutions started with a loading rate of 100 mg/l applying a 15-minute period of magnetic stirring combined with a treatment with ultrasonic waves. The obtained aqueous mixture was subsequently magnetically stirred for a period of two days to ensure maximum dissolution in test medium and subsequently filtered through a 0.45 µm membrane filter (rc55, Whatman).The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the filtrate 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 (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Length at study initiation (length definition, mean, range and SD):
Limit test: 2.7 ± 0.2 cm
- Weight at study initiation (mean and range, SD):
Limit test: 0.46 ± 0.07 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: no
HOLDING
Quarantine/Acclimatisation: At least 12 days after delivery
Medium: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, 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
Measurements: pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day.
In addition, pH and temperature were measured before transferring the fish to the test system.
Water quality parameters: Were kept within the optimum limits for the respective fish species.
Feeding: Daily with pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- 180 mg CaCO3/l
- Test temperature:
- 21.0-22.2 °C
- pH:
- 7.4-7.8
- Dissolved oxygen:
- 5.9-9.2 mg O2/l
- Salinity:
- not measured
- Nominal and measured concentrations:
- Nominal concentrations: A 0.45 µm filtered solution prepared at a loading rate of 100 mg/l (limit concentration)
Measured concentrations: Analysis of the sample taken from the limit concentration (i.e. the undiluted filtrate) at the start of the test showed actual concentration of 220 µg/l. The measured concentration dropped to 14 µg/l, i.e. 6.5 % of initial at the end of the test. Based on these results, the average exposure concentration was calculated to be 56 µg/l.
Note that the measured concentration at the end of the test was above the water solubility of the test substance which was determined to be ≤24.5 ng/l. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 10 litres, all-glass, containing 9.8 litres of test solution
- Type (delete if not applicable): open
- Aeration: no
- Type : static
- No. of organisms per vessel: 7 (limit test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 0
- Biomass loading rate: 0.33 g/litre
TEST MEDIUM / WATER PARAMETERS
Medium: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, 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
Measurements pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day.
In addition, pH and temperature were measured before transferring the fish to the test system.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours of light
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): NOEC and 24, 48, 72 and 96 h EC50
TEST CONCENTRATIONS
- Spacing factor for test concentrations: none - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol (PCP)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: -
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 56 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: -
- Details on results:
- - Other biological observations: No effects
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses:no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
The 96h-LC50 for carp exposed to PCP was estimated to be 0.15 mg/l (95 % confidence interval between 0.10 and 0.22 mg/l). This effect was already reached within 24 hours of exposure. - Reported statistics and error estimates:
- The average exposure concentrations were calculated as, being the geometric means of the concentrations of FAT 41043/A measured in the samples taken at the start (Ct=0) and the end of the test (Ct=96).
No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum soluble concentration). - Sublethal observations / clinical signs:
Incidence of mortality and total mortality during the limit test
FAT 41043/A
% of filtrate
prep. at 100 mg/l
Initial
number
of fish
Cumulativemortality
Total
Mortality
(%)
3h
24h
48h
72h
96h
control
7
0
0
0
0
0
0
100 (56 µg/l)
7
0
0
0
0
0
0
() – between brackets: average exposure concentration
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 h-LC50 was beyond the range tested, i.e. exceeded an average exposure concentration of 56 µm/l obtained in an undiluted filtrate prepared at a loading rate of 100 mg/l.
Due to the very low solubility of FAT 41043/A in water, concentration levels that might be toxic for carp could not be reached.
Reference
Description of key information
The short term toxicity to fish of FAT 41043/A was investigated according to OECD Guideline Nr. 203, EU Method C.1 and GLP principles. The 96h-LC50 was beyond the range tested, i.e. exceeded an average exposure concentration of 56 µg/l obtained in an undiluted filtrate prepared at a loading rate of 100 mg/l.
Key value for chemical safety assessment
Additional information
Due to the very low solubility of FAT 41043/A in water, concentration levels that might be toxic for carp could not be reached.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)