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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
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Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 October 2011 to 02 November 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 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- 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
- 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=48 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 were prepared by subsequent dilutions of the filtrate in test medium. The final test solutions were all clear and colourless. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Reason for selection: This system has been selected as an internationally accepted invertebrate species.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20 %, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: For the test selection of young daphnids with an age of <24 hours, from parental daphnids of more than two weeks old. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- -
- Post exposure observation period:
- none
- Hardness:
- 180 mg/l expressed as CaCO3
- Test temperature:
- 19.3 - 20.5 °C
- pH:
- 8.0-8.1
- Dissolved oxygen:
- 8.9-9.3 mg O2/l
- Salinity:
- not measured
- Nominal and measured concentrations:
- Nominal concentrations: 0.1, 1.0, 10 and 100 % of a 0.45 µm filtered solution prepared at a loading rate of 100 mg/l.
Measured concentration: Analysis of the sample taken at the start of the test showed measured concentration of 3.0 µg/l. The measured concentration remained stable during the test (81 % of initial). Therefore, the effect parameters were expressed in terms of initially measured concentrations.
Note that the measured concentration was above water solubility of the test substance which was determined to be ≤24.5 ng/l. - Details on test conditions:
- Test duration: 48 hours
Test type: Static
Test vessels: 100 ml, all-glass
Medium: Adjusted ISO medium
Number of daphnids: 20 each for the control and the highest concentration, 10 each for the lower concentrations
Loading: 5 per vessel containing 80 ml of test solution
Number of replicates: 4 for the control and the highest concentration, 2 for the lower concentrations
Light: 16 hours photoperiod daily
Feeding: No feeding
Aeration: No aeration of the test solutions.
Introduction of daphnids: Within 1¼ hours after preparation of the test solutions. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: -
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 3 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: -
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 3 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: -
- Details on results:
- No immobility was observed at any of the groups tested.
- Behavioural abnormalities: no
- Mortality of control: no - Results with reference substance (positive control):
- The actual responses in this reference test with K2Cr2O7 were just outside (below) the ranges of the expected historical responses at the different concentrations, i.e. a 48h-EC50 between 0.3 and 1.0 mg/l. Hence, the sensitivity of this batch of D. magna was slightly higher when compared to the historical data collected at NOTOX.
The 24 h EC50 was 0.53 mg/l with a 95 % confidence interval between 0.47 and 0.62 mg/l.
The 48 h EC50 was 0.28 mg/l with a 95 % confidence interval between 0.26 and 0.32 mg/l. - Reported statistics and error estimates:
- No EC50 could be calculated because the test substance proved to be non-toxic (EC50 > maximum soluble concentration).
- Validity criteria fulfilled:
- yes
- Conclusions:
- FAT 41043/A did not induce acute immobilisation of Daphnia magna at 3.0 µg/l after 48 hours of exposure (NOEC).
The 48h-EC50 was beyond the range tested, i.e. exceeded an initially measured concentration of 3.0 µg/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 daphnids could not be reached.
Reference
Table1 Acute immobilisation of daphnids after 24 and 48 hours
FAT 41043/A TE % of filtrate prep. at 100 mg/l |
Vessel number
|
Number Daphnia exposed |
Response at 24 h |
Response at 48 h |
||
number |
Total % |
number |
Total % |
|||
control |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
0.1 |
A B |
5 5 |
0 (4) 0 (5) |
0 |
0 (4) 0 (1) |
0 |
1.0 |
A B |
5 5 |
0 0 |
0 |
0 0 |
0 |
10 |
A B |
5 5 |
0 0 |
0 |
0 0 |
0 |
100 [3.0] |
A B C D |
5 5 5 5 |
0 0 (4) 0 0 |
0 |
0 0 (2) 0 0 |
0 |
[] – between brackets: initially measured concentration (µg/l)
( ) between brackets: number of daphnia observed trapped at the surface of the test solutions. These organisms were reimmersed into the respective solutions before recording of mobility.
Description of key information
The short-term toxicity to aquatic invertebrates of FAT 41043/A was investigated according to OECD Guideline Nr. 202, EU Method C.2 and GLP principles. The 48h-EC50 was beyond the range tested, i.e. exceeded an initially measured concentration of 3.0 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 daphnids 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.
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