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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 446-800-7 | CAS number: 175357-18-3
- 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-11-30 to 2010-05-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study processed conform to guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- LCA 08042
- IUPAC Name:
- LCA 08042
- Details on test material:
- - Name of test material (as cited in study report): LCA08042
- Lot/batch No.: 0826000002
- Expiration date of the lot/batch: September 16, 2011
- Storage condition of test material: At room temperature (about 20°C), away from direct sunlight
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
- Sampling method:Treatment samples and control samples were thawed at 25 °C for 30 minutes and shaken manually to obtain homogeneous sample solutions. Aliquots of the final solutions were analyzed by HPLC with UV/VIS detection
- Sample storage conditions before analysis: The samples were stored deep-frozen and protected from light until analysis was performed.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
Due to the low water solubility of the test item, a dispersion with the loading rate of 120 mg/L was prepared by dispersing 120.07 mg of the test item in 1000 mL of test water. The dispersion was supported by ultrasonic treatment for 45 minutes and intense stirring by a magnetic stirrer over 2 hours in the dark, to dissolve a maximum amount of the test item in the dispersion.
The stirring period of 2 hours was chosen according to the results of a pre-experiment (without GLP). After the stirring period, the dispersion of the test item was filtered through a membrane filter (pore size 0.20 μm). The undiluted filtrate was used as the highest concentrated test medium and as stock solution for the preparation of the test media of lower test concentrations. For the preparation of the test media of the lower test concentrations, the filtrate was diluted with test water. The test media were prepared just before the start of the test (= start of exposure).
- Eluate: not applicable
- Differential loading: a dispersion with the loading rate of 120 mg/L was prepared
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No auxiliary solvent or emulsifier was used.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the test period.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna Strauss
- Source: A clone of this species (defined by the supplier as clone 5) was originally supplied by the University of Sheffield / UK in 1992. Since that time, the clone has been bred at Harlan Laboratories.
- Age at study initiation (mean and range, SD): 6-24 hours
- Method of breeding: in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests
- Feeding during test: The daphnids were not fed during the test.
ACCLIMATION
- Acclimation period: Daphnids were bred in reconstituted water of the quality identical to the water quality used in the tests. Therefore, acclimation was deemed not neccesary.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: During breeding, daphnids are generally fed three times a week with an algal suspension of the green algae Desmodesmus subspicatus CHODAT, Strain No. 86.81 SAG, supplied by the Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, 37073 Göttingen / Germany) and cultivated at Harlan Laboratories under standardized conditions or a mixture of this algal suspension and a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany).
- Feeding frequency: three times a week
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- no post-observation was performed
Test conditions
- Hardness:
- 2.5 mmol/L
- Test temperature:
- 21°C
- pH:
- At the beginning and end of the test medium renewal periods, the pH values of the test media were between 7.1 and 7.9.
- Dissolved oxygen:
- The dissolved oxygen concentrations in the test media and control were at least 8.0 mg/L.
- Salinity:
- Not particularly stated in the study report. Reconstituted test water according to ISO 6341 [1] was used in the study. It consisted of analytical grade salts dissolved in purified water. The detailed mineral composition of the reconstituted water is given in the original study report.
- Nominal and measured concentrations:
- nominal concentration: 110 mg/L
analytical (measured) concentration: 92-96 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 100 mL glass beakers filled with 50 mL of test medium
- Aeration: The test water was aerated prior to the start of the study until oxygen saturation was reached. During the test period, the test water was not aerated.
- Renewal rate of test solution (frequency/flow rate): A semi-static test with test medium renewal after 24 hours was performed during the test period of 48 hours. After 24 hours, the test organisms were placed in clean test vessels with freshly prepared test medium.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 1 daphnid per 2 mL of water
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water according to ISO 6341 was used in the study.
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1
- Culture medium different from test medium: no
- Preparation of test water: Due to the nonspecific solubility of the test item, a dispersion of the test item with the loading rate of 110 mg/L was continuously stirred at room temperature in the dark over 2 hours. Then, the dispersion was filtered. The undiluted filtrate of the dispersion was used as the test medium. Additionally, a control was tested in parallel. The preparation of the test medium was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000
OTHER TEST CONDITIONS
- Photoperiod and light intensity: A 16-hour light to 8-hour dark cycle with a 30-minute transition period was used. Light intensity during the light period was approximately between 520 and 680 Lux.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- In the control and at the loading rate of 110 mg/L, no immobilized test organisms were observed during the test period of 48 hours (Table 1).
Therefore, the 48-hour NOEC and the 48-hour EC0 were determined to be at least at the loading rate of 110 mg/L. The 48-hour NOEC and the 48 hour EC0 might even be higher, but loading rates higher than 110 mg/L were not tested. The 48-hour EC50 and the 48 hour EC100 were clearly higher than the loading rate of 110 mg/L.
In conclusion, the test item LCA08042 had no acute toxic effects on Daphnia magna up to 110 mg/L (nominal) in the test water under the present test conditions.
No remarkable observations were made concerning the appearance of the test medium. It was a clear solution throughout the entire test duration. - Results with reference substance (positive control):
- For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in September 2009 (48-hour EC50: 1.1 mg/L, study C63680) indicated that the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 2000 to 2009: 0.53-1.1 mg/L).
- Reported statistics and error estimates:
- no statistics applied
Any other information on results incl. tables
Table 1: Effect of LCA08042 on the Mobility of Daphnia magna
Treatment / Loading rate |
No. of |
Immobilized |
Immobilized |
||
(mg/L) |
|
No. |
% |
No. |
% |
Control |
20 |
0 |
0 |
0 |
0 |
110 |
20 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item LCA08042 had no acute toxic effects on Daphnia magna up to 110 mg/L (nominal) in the test water under the present test conditions.
- Executive summary:
The acute toxicity of the test item LCA08042 to Daphnia magna was determined in a 48‑hour semi-static test according to the EU Commission Directive 92/69/, Part C.2, the Commission Regulation (EC) No 440/2008, Part C.2 and the OECD Guideline for Testing of Chemicals, No. 202 (2004) under GLP.
A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the test organisms up to the solubility limit of the test item in test water.
Due to the nonspecific solubility of the test item, a dispersion of the test item with the loading rate of 110 mg/L was continuously stirred at room temperature in the dark over 2 hours. Then, the dispersion was filtered. The undiluted filtrate of the dispersion was used as the test medium. Additionally, a control was tested in parallel.
The measured concentrations of the test item in the test medium were between 94 and 96 mg/L at the start and at the end of each test medium renewal period. Consequently, the test water renewal ensured nearly constant concentration of the test item during the test and the reported biological results are related to the loading rate of the test item of 110 mg/L.
In the control and at the loading rate of 110 mg/L no immobilized daphnids were determined during the test period of 48 hours.
The biological test results were as follows:
Loading rate
(mg/L)– 24-hour EC50:
>110
– 24-hour EC0:
≥110
– 24-hour EC100:
>110
– 48-hour EC50:
>110
– 48-hour EC0and 48-hour NOEC:
110
– 48-hour EC100:
>110
In conclusion, the test item LCA08042 had no acute toxic effects on Daphnia magna up to 110 mg/L (nominal) in the test water under the present test conditions.
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.