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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 479-100-5 | CAS number: 577705-90-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- September 9 to October 11, 2013
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- Due to the low water solubility of the test item, the organisms were exposed to a Water Accomodated Fraction (WAF) of the substance.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- Due to the low water solubility of the test item, the organisms were exposed to a Water Accomodated Fraction (WAF) of the substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- XA31
- IUPAC Name:
- XA31
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of the test item (as cited in the study report): XA31
Description: off-white powder;
Storage conditions: room temperature in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- 1st instar Daphnia magna derived from in-house laboratory cultures. Adult Daphnia were mainteined in 150mL glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20°C. The lighting cycle was controlled to give a 16hours light and 8 hours darkness cycle with 20 minute dawn and dusk tansition periods.
Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24hours old. The young were removed from the cultures and uses for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- The number of immobilized Daphnia and any adverse reactions to exposure were recorded after 24 and 48 hrs.
Test conditions
- Hardness:
- 250 mg/l as CaCO3
- Test temperature:
- app. 21°C
- pH:
- 7.8 +/- 0.2
- Nominal and measured concentrations:
- nominal loading rated of 1.0, 1.8, 3.2, 5.6 and 10 mg/L.
- Details on test conditions:
- 20 daphnids (4 replicates of 5 animals) were exposed to Water Accomodated Fractions (WAFs) of the test item for 48 h at temperature of app. 21°C under static test conditions
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/l
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 7.4-8.7
Any other information on results incl. tables
Range-Finding Test
Cumulative immobilization data from the exposure of Daphnia Magna to the test item during the range-finding test are give in Table 1
Nominal Loading Rate (mg/L) |
Cumulatie Immobilized Daphnia (Initial Population: 10 per replicate) |
|
24 h |
48 h |
|
Control |
0 |
0 |
1 |
0 |
0 |
10 |
10 |
10 |
100 |
10 |
10 |
No immobilization was observed at 1.0 mg/L loading rate WAF. However, immobilization was observed at 10 and 100 mg/L loading rate WAF.
Based on this information loading rates of 1, 1.8, 3.2, 5.6 and 10 mg/L were selected for the definitive test.
Analysis of the 1, 10 and 100 mg/L loading rate WAFs at 0hours showed measured concentrations of 0.0015, 0.022 and 0.071 mg/L respectively. 1, 10 and 100 mg/L loading rate WAFs at 48hours showed measured concentrations of 0.00052, 0.022 and 0.066 mg/L respectively. The slight decline in measured concentration observed in the 1 mg/L loading rate over the test period was due to an error in sampling, whereby the control was sampled in error and not discarded prior to sampling the 1.0mg/L loading rate, rather than true instability of the test item.
Definitive Test
Chemical Analysis of Test Loading Rates
Analysis of the 5.6 and 10 mg/L loading rate WAFs at 0 hour showed measured concentrations of 0.0086 and 0.016 mg/L respectively. Analysis of the 5.6 and 10 mg/L loading rate WAFs at 48hours showed measured concentrations of 0.0081 and 0.016 respectively.
The toxicity of the test item cannot be attributed to a single component or a mixture of components but to the test item as a whole. In addition, the measured concentration obtained for the WAFs are not stability indicating and are rather a confirmation that the test item is present.
Immobilization Data
Analysis of the immobilization data by the trimmed Spearman-Karber method at 24 and 48 hours based on the nominal loading rates gave the following results:
Time (h) |
EL50 (mg/L Loading Rate WAF) |
95% Confidence limits (mg/L Loading Rate WAF) |
24 |
9.5 |
7.7 – 12 |
48 |
8.0 |
7.4 – 8.7 |
The No Observed Effect Loading rate after 24 and 48 hours exposure was 5.6 mg/L loading rate WAF. Correspondingly the Lowest Effect Loading rate was considered to be 10mg/L loading rate WAF.
Significant immobilization was observed in the 1.8 mg/L loading rate WAF test group. However, this was considered not to be a true toxic effect of the test item as this did not follow a concentration, dependent pattern. In addition, both surviving and immobilized daphnids in this test group were observed to be trapped on the surface. As this effect was not observed in any other test group, this effect was considered not to be a true toxic effect of the test item but due to possible contamination of the test preparation. Single immobilized daphnids were observed in the control and 3.2 mg/L loading rate WAF groups however these were considered not to be true toxic effects as less than 10%immobilization occurred.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Analysis of the 5.6 and 10 mg/L loading rate WAFs at 0 hour showed measured concentrations of 0.0086 and 0.016 mg/L respectively. Analysis of the 5.6 and 10 mg/L loading rate WAFs at 48hours showed measured concentrations of 0.0081 and 0.016 respectively.
The toxicity of the test item cannot be attributed to a single component or a mixture of components but to the test item as a whole. In addition, the measured concentration obtained for the WAFs are not stability indicating and are rather a confirmation that the test item is present.
Exposure of the freshwater invertebrate Daphnia Magna to the test item has been investigated and gave the following results:
EL50 (Loading Rate WAF) 48 hrs = 8.0 mg/l
NOEL (Loading Rate WAF) = 5.6 mg/l
LOEL (Loading Rate WAF) = 10 mg/l - Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna.
The method followed was designed to be compatible with the OECD Guideline for testing of chemicals (April 2004) no.202,"Daphnia sp., Acute immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) no. 440/2008.
Exposure of the freshwater invertebrate Daphnia Magna to the test item has been investigated and gave the following results:
Time (h)
EL50
(mg/L Loading Rate WAF)
95%Confidence limits
(mg/L Loading Rate WAF)
NOEL (mg/L Loading Rate WAF)
LOEL (mg/L Loading Rate WAF)
48
8.0
7.4 – 8.7
5.6
10
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.