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EC number: 614-295-4 | CAS number: 68131-40-8
- 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:
- 08 June 2010 - 08 September 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with international guidelines, and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.0970, 0.213, 0.470, 1.03, 2.27 and 5 mg/L as WAF
- Sampling method: At the start of the definitive test and on Day 3, replicate samples (50 mL) were taken from the freshly prepared control and test media. On Days 1 and 4 replicate expired samples (50 mL) of media were taken from each tank.
- Sample storage conditions before analysis: On each occasion, both replicate samples were stored in a freezer until analysis was performed - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: At each concentration, the test substance (4 or 9 µL, 18.8, 20.6, 45.4 or 100 mg) was dispersed in dechlorinated tap water in a glass vessel (20 or 40 L). The contents of each vessel were stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours. Aliquots (15 L) were then removed mid vessel to provide the Water Accommodated Fraction (WAF’s) at a nominal loading rates of 0.0970, 0.213, 0.470, 1.03, 2.27 and 5 mg/L.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): At all concentrations, the test media were colourless dispersions. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Source: Commercial fish farm in the UK
- Age at study initiation (mean and range, SD): Not specified, but calculated to be between 6-10 weeks.
- Length at study initiation (length definition, mean, range and SD): Mean total length was 4.92 cm.
- Weight at study initiation (mean and range, SD): Mean wet weight was 1.38 g
- Feeding during test: No food was given during the 19-hour period immediately before exposure or during the exposure period itself.
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): No, the fish were held in an aerated supply of diluent water under flow-through conditions until use.
- Type and amount of food: Commercial fish food at an amount equivalent 2% of the total wet-weight of fish in the holding tank.
- Feeding frequency: Daily.
- Health during acclimation (any mortality observed): No medication was given during the holding period, and mortality was recorded as 2% in the 14 days before the definitive test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Test temperature:
- 15±2°C.
- pH:
- Control solutions: 8.07 - 8.39
Expired solutions: 8.04 - 8.43 - Dissolved oxygen:
- Fresh solutions: 8.7 - 9.4 mgO2/L
Expired solutions: 9.2 - 9.5 mgO2/L - Salinity:
- Not applicable for a freshwater study.
- Nominal and measured concentrations:
- Nominal concentrations: 0.0970, 0.213, 0.470, 1.03, 2.27 and 5 mg/L as WAF.
At nominal loading rates of 0.970, 0.213, 0.470 and 1.03 mg/L, the levels of TOC measured in the test media were below that found in the control media on one or more occasions during the definitive test; therefore, it was not possible to quantify the level of carbon that was attributable to the test substance at these exposure levels.
At loading rates of 2.27 and 5 mg/L, the levels of TOC measured in samples of the test media were 0.260 and 1.21 mgC/L (after correction for the control) in samples of freshly prepared media and 0.928 and 2.95 mgC/L in samples of expired (24-hour-old) media. Based on a geometric mean, the overall measured TOC levels were 0.486 and 1.89 mgC/L.
Due to the complex composition of Softanol 30, oxidation of the organic carbon may have been incomplete under analytical conditions employed, so the levels of TOC measured in the test media may have been underestimated. - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, filled to a depth of 17.3 cm (15 litres of dilution water or test solution).
- Aeration: Supplementary aeration was provided via narrow bore glass tubes.
- Renewal rate of test solution (frequency/flow rate): Semi-static - daily batch renewal of the media to ensure the maintenance of satisfactory environmental conditions and in an attempt to maintain stable exposure levels.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: 0.644 g bodyweight/litre
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Filtered dechlorinated tap water blended with tap water that had been softened and subsequently treated by reverse osmosis to a hardness of 150-200 mg/L as CaCO3.
- Total organic carbon: 1.1 mg/L
-Calcium: 43 mg/l
- Magnesium: 2.0 mg/l
- Ca/mg ratio: 43/2.0 (=21.5)
- Conductivity: 240 uS/cm
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16h light : 8h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality, defined as absence of respiratory movement, and absence of response to physical stimulation of the caudal peduncle. Observations were
taken at approximately 2, 4, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2-fold
- Range finding study test concentrations: not reported. Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- 1.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL 1.03 - 2.27
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 0.47 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: They were observed at 1.03 mg/L and higher concentrations and comprised of lethargy, darkened pigmentation, hyperventilation, loss of orientation and immobility.
- Mortality of control: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: At all concentrations, the test media were colourless dispersions. Due to the complex composition of Softanol 30, oxidation of the organic carbon may have been incomplete under analytical conditions employed, so the levels of TOC measured in the test media may have been underestimated. - Results with reference substance (positive control):
- Not applicable
- Sublethal observations / clinical signs:
Highest nominal loading rate resulting in no mortality: 1.03 mg/L WAF.
Lowest nominal loading rate resulting in 100% mortality: 2.27 mg/L WAF.
- Validity criteria fulfilled:
- yes
- Remarks:
- Environmental parameters remained within acceptable limits throughout the duration of the study.
- Conclusions:
- The 96 h LL50 value for Softanol 30 with rainbow trout was 1.53 mg/L.
The no-observed effect loading rate (NOELR) for DEGDB with rainbow trout was 0.470mg/L. - Executive summary:
A study was performed to assess the acute toxicity of Softanol 30 to rainbow trout (Oncorhynchus mykiss) under semi-static conditions with daily renewal of the media.
The study was conducted in accordance with EC Methods for Determination of Ecotoxicity, Annex to Commission Regulation (EC) No 440/2008 (O.J. No. L142/446, 2008) Part C, Method 1 “Acute Toxicity For Fish” and the OECD Guideline for Testing of Chemicals No. 203 “Fish, Acute Toxicity Test” (1992).
Groups of seven juvenile fish were exposed to water accommodated fractions (WAFs) of Softanol 30 prepared from aqueous mixtures with initial nominal concentrations (loading rates) of 0.0970, 0.213, 0.470, 1.03, 2.27 and 5 mg/L. The test media were prepared in dechlorinated tap water by the direct addition of the test substance to the dilution medium. To aid dissolution, the aqueous mixtures were stirred for approximately 24 hours and then left to stand for approximately 24 hours before the aqueous phase (WAF) was removed and used as the test medium at each concentration.
The multi-component nature of the test substance made it unsuitable for analysis using chromatographic methods. Consequently, exposure levels were monitored using carbon analysis (Total Organic Carbon, TOC) during the test.
At nominal loading rates of 0.970, 0.213, 0.470 and 1.03 mg/L, the levels of TOC measured in the test media were below that found in the control media on one or more occasions during the test, therefore, it was not possible to quantify the level of carbon that was attributable to the test substance at these exposure levels.
At loading rates of 2.27 and 5 mg/L, the levels of TOC measured in samples of the test media were 0.260 and 1.21 mgC/L (after correction for the control) in samples of freshly prepared media and 0.928 and 2.95 mgC/L in samples of expired (24-hour-old) media. Based on a geometric mean, the overall measuredTOC levels were 0.486 and 1.89 mgC/L.
Observations of the fish were made after approximately 2, 4, 24, 48, 72 and 96 hours of exposure.
After 96 hours, the highest nominal loading rate at which no mortality had occurred was 1.03 mg/L and the lowest at which there was 100% mortality was 2.27 mg/L. Treatment‑related effects were exhibited at 1.03 mg/L and higher concentrations.
Based on these findings the following values have been estimated:
Nominal loading rates (WAFs):
96-hour LL50value: 1.53 mg/L (95% confidence limits of 1.03, 2.27 mg/L)
NOELR (No Observed Effect Loading Rate): 0.470 mg/L
Reference
Description of key information
One study is available and valid.
In a 96 -h acute toxicity study, rainbow trout (Oncorhynchus mykiss) (7/group) were exposed to Softanol 30 at nominal concentrations of 0 (control), 0.0970, 0.213, 0.470, 1.03, 2.27 and 5 mg/L as Water Accommodated Fractions (Huntingdon Life Sciences, 2010, report PLZ0026. Mortalities were observed at the top two levels, 2.27 and 5 mg/L. The 96-hour LL50value for Softanol 30 with rainbow trout was 1.53 mg/L WAF, with 95% confidence limits of 1.03 and 2.27mg/L. The “no observed effect loading rate” (NOELR) was 0.470 mg/L WAF.
This toxicity study is classified as acceptable and fully satisfies the guideline requirement for short-term toxicity to fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1.53 mg/L
Additional information
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