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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-382-9 | CAS number: 106-30-9
- 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 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 2017-03-26 to 2017-04-03
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1.5 mg/L
- Sampling method: The limit concentration and the control are analytically verified from all freshly prepared and aged test media.
- Sample storage conditions before analysis: All samples were stored at 6 ± 2 °C until the start of the analysis. Prepared samples were stored in the autosampler at room temperature until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solution of 50 mg/L in demineralized water. After a stirring period of 24 hours ± 1 hour at room temperature with 600 rpm, an appropriate volume of this stock solution was pipetted into a test vessel filled with an appropriate volume of dilution water. The test media was mixed with an ultraturrax.
- Controls: 7
- Test concentration: 1.50 mg/L - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio
- Source: single brood, see study report for details on source.
ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Sera Vipan, 4 % of the fish body weight per feeding day.
- Feeding frequency during acclimation: 3 times per week, not fed 24 h before the test start - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- Total hardness of dilution water: 64 mg/L as CaCO3
- Test temperature:
- 22.7-23°C
- pH:
- pH at the start of exposure: 7.61-7.72 (1.01 mg/L), 7.51-7.71 (control)
pH at the end of exposure: 7.51-7.71 (1.01 mg/L), 7.41-7.65 (control) - Dissolved oxygen:
- Dissolved oxygen of dilution water: 9.97 mg/L
Dissolved oxygen at the start of exposure: 100% (1.01 mg/L), 100% (control)
Dissolved oxygen at the end of exposure: 90-92% (1.01 mg/L), 92-95% (control) - Nominal and measured concentrations:
- Nominal: 1.5 mg/L
Measured: 1.01 mg/L (geometric mean) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 13 L glass aquaria
- Type (delete if not applicable): closed, covered with a floating lid
- Material, size, headspace, fill volume: Glass aquaria of 13 L, filled with approximately 8 L of dilution water
- Aeration: No aeration
- Renewal rate of test solution (frequency/flow rate): 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): One replicate
- No. of vessels per vehicle control (replicates): One replicate
- Biomass loading rate: 0.06 g fish per litre test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin
- Chlorine:filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Alkalinity: 1.00 mmol/L
- Intervals of water quality measurement: quarterly
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 7 - 750 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Biological Parameters: observed for visible abnormalities after 2, 24, 48, 72 and 96 h. Measire size and weight of the control fish at the end of the exposure.
- Physical Properties: The pH-value, temperature and oxygen saturation were measured in all test vessels at the start of the exposure and every 24 hours and after renewal of the test media from fresh and old test media. Total hardness was determined at the start of the exposure out of the control. Water temperature was recorded once per hour during the test. Light intensity was measured at the start of the exposure.
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Taking into account the aquatic toxicity data of the test item the test was performed without a range-finding test. The threshold concentration (TC) is based on the toxicity data of the test item of an alga toxicity test (ErC50(0-72 h) = 0.440 mg/L). Considering the loss of the substance during the exposition, a nominal concentration of 1.50 mg/L was performed in the limit test.
- Test concentrations: 1.50 mg/L were tested as a threshold concentration in a limit test. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1.01 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 1.01 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 1.01 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Biological data: No symptoms of toxicity were observed for both test and control group. No mortality occurred.
- Physicochemical data: The environmental conditions (pH-value, temperature, O2 saturation) were within the acceptable limits. The continuous measuring of water temperature was in the valid range of 23 ± 2 °C. The measured light intensity was in the given range of 7 - 750 lux and ranged from 106 to 112 lux (mean value 109 lux). - Sublethal observations / clinical signs:
Stability test (non-GLP):
Exposure time (h) measured conc (mg/L) % of nominal concentration 0 0.529 88 24 0.379 63 Observations in the Test Vessels:
Geometric mean measured concentration [mg/L]
Effect
Number of fish effected after different exposure periods [hours]
2
24
48
72
96
1.01
Normal behaviour
7/7
7/7
7/7
7/7
7/7
Control
Normal behaviour
7/7
7/7
7/7
7/7
7/7
Cumulative Mortality [%] in the Test Vessels:
Geometric mean measured concentration [mg/L]
Cumulative Mortality [%] after different exposure periods [hours]
2
24
48
72
96
1.01
0
0
0
0
0
Control
0
0
0
0
0
Analytical data:
Nominal concentration (mg/L) Measured concentration (mg/L) geometric mean 0h, fresh 24h, aged 24h, fresh 48h, aged 48h, fresh 72h, aged 72h, fresh 95h, aged 1.5 1.43 0.804 1.22 0.693 1.34 0.735 1.33 0.859 1.01 - Validity criteria fulfilled:
- yes
- Conclusions:
- The threshold concentration of the test item (1,5 mg/L nominal, 1.01 mg/L geometric mean) was found to have no effect on the vitality of zebrafish. In conclusion, the LC0 corresponds to the geometric mean measured concentration 1.01 mg/L. The LC50 and the LC100 correspond to the geometric mean measured concentration > 1.01 mg/L. All effect levels are given based on the geometric mean measured concentration of the test item.
- Executive summary:
The acute toxicity of the test item to fish (zebrafish) was determined according to the OECD Guideline for Testing of Chemicals No. 203 (1992) and EU Council Regulation No. 440/2008/C.1 (2008).
A semi-static limit test was performed with a threshold concentration of 1.50 mg/L. The test had a duration of 96 hours. 7 test organisms were exposed each for the test concentration and the control. The water quality parameters pH-value, temperature and oxygen saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable limits.
The determination of the test concentration was carried out via SPME-GC-MS with a polydimethylsiloxane (PDMS) fiber. Evaluation was carried out from all freshly prepared media after 0, 24, 48 and 72 h and from the corresponding 24 h aged test media after 24, 48, 72 and 96 h. The measured concentrations in freshly prepared media were in the range of 82 to 96 % of the nominal values. In corresponding 24 h aged test media, the measured concentrations were in the range of 46 to 57 % of the nominal values. Therefore, all effect values were based on the geometric mean measured concentration of the test item.
In conclusion, the LC0 corresponds to the geometric mean measured concentration 1.01 mg/L. The LC50 and the LC100 correspond to the geometric mean measured concentration > 1.01 mg/L.
Reference
Description of key information
For this endpoint, there is one acute fish test available performed according to OECD 203, limit test and semi-static test set-up. Fish were exposed for 96h. The LC0 corresponds to the geometric mean measured concentration 1.01 mg/L. The LC50 and the LC100 correspond to the geometric mean measured concentration > 1.01 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1.01 mg/L
Additional information
For this endpoint only one test is available. In this acute toxicity test with fish (zebrafish), the effects of a threshold concentration of 1.50 mg/L of the test item were determined according to OECD 203 (1992).
The test had a duration of 96 hours. 7 test organisms were exposed each for the test concentration and the control. The water quality parameters pH-value, temperature and oxygen saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable limits.
The determination of the test concentration was carried out via SPME-GC-MS with a polydimethylsiloxane (PDMS) fiber. Evaluation was carried out from all freshly prepared media after 0, 24, 48 and 72 h and from the corresponding 24 h aged test media after 24, 48, 72 and 96 h. The measured concentrations in freshly prepared media were in the range of 82 to 96 % of the nominal values. In corresponding 24 h aged test media, the measured concentrations were in the range of 46 to 57 % of the nominal values. Therefore, all effect values were based on the geometric mean measured concentration of the test item.
In conclusion, the LC0 corresponds to the geometric mean measured concentration 1.01 mg/L. The LC50 and the LC100 correspond to the geometric mean measured concentration > 1.01 mg/L.
As key value for LC50 the lowest concentration from the range was selected: 1.01 mg/L.
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.