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EC number: 238-830-2 | CAS number: 14765-30-1
- 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:
- March 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Threshold Concentration approach adopted - single limit concentration applied. No mortality nor sub-lethal effects observed - i.e. 96 hour LC50 likely to be significantly higher than 12 mg/L.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- Threshold concentration test
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- Threshold concentration test
- Principles of method if other than guideline:
- The OECD 201 and OECD 202 studies were performed prior to this study. The lowest EC50 value derived from these studies (in this case the EyC50 from the OECD 201 Algal Inhibition study) was employed to fix a single threshold concentration to cinduct the study, in the interests of animal wellfare and according to the OECD Guidance Document : Short guidance on the threshold approach for acute fish toxicity testing. Series on testing and assessment No. 126 (2010).
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- FRESKOMENTHE
Lot No. VE00426966
Purity 99.2%
Expiry Date 19 February 2018 - Analytical monitoring:
- yes
- Remarks:
- GC-FID
- Details on sampling:
- The limit concentration and the control were analytically verified via GC-FID from freshly prepared media after 0 and 72 h and from corresponding 24 h aged test media after 24 and 96 h.
- Vehicle:
- no
- Details on test solutions:
- 12.0 mg/L was tested as a threshold concentration in a limit test. Taking into account the aquatic toxicity data of the test item the test was performed without a range-finding test. The threshold concentration (TC) was based on the toxicity data obtained by an acute daphnia toxicity test (EC50, 48h = 25 mg/L, nominal concentration) and alga toxicity test (ErC50 (0-72 h) = 30.6 mg/L, EyC50 (0-72 h) = 12.2 mg/L, nominal concentration) both KLIX, 2017.
An appropriate volume of the test item was pipetted directly into a test vessel filled with an appropriate volume of dilution water. The test media were mixed with an ultraturrax (1 min, 12000 rpm). This procedure was repeated for every water renewal. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Holding was performed at the test facility at 23 ± 2°C and diffuse light (7 – 750 Lux, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days prior to the start of exposure were used for testing. No disease treatments were administered throughout holding and testing.
- Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- Tap water of local origin was used for holding. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 67 mg/L as CaCO3
- Test temperature:
- Min. 22.1 °C;
Max. 23.0 °C;
Mean temperature +/- Standard Deviation : 22.5 +/- 0.2 °C - pH:
- pH 7.32 - 7.73
- Dissolved oxygen:
- 78 - 100% Saturation
- Nominal and measured concentrations:
- Nominal Concentration of Test Item = 12.0 mg/L
Geometric Mean Measured Concentration = 10.7 mg/L - Details on test conditions:
- A semi-static test with daily renewal of the test media was performed. With regard to the properties of the test item, the test aquaria were covered with a floating lid (i.e. with aluminum foil) to reduce the loss of the test item via the surface.
12.0 mg/L was tested as a threshold concentration in a limit test. Taking into account the aquatic toxicity data of the test item the test was performed without a range-finding test. The threshold concentration (TC) was based on the toxicity data obtained by an acute daphnia toxicity test (EC50, 48h = 25 mg/L, nominal concentration) and alga toxicity test (ErC50 (0-72 h) = 30.6 mg/L, EyC50 (0-72 h) = 12.2 mg/L, nominal concentration) both KLIX, 2017.
Control - 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicate.
Test Vessel - Glass aquaria of 13 L were used, filled with approximately 10 L of dilution water (dimensions: 25.5/18/28 cm, depth of water: 20 cm), covered with a floating lid (e.g. with aluminum foil), to reduce the loss of the test item, containing 10 L of water.
Replication - One replicate for the limit concentration and the control.
The fish density in the tanks was 0.19 g fish per litre test solution. Average body length at the test end: 2.74 cm (2.5 – 3.0 cm). Average body weight at the test end: 0.277 g (measurement of all fish together). The measurements of size and weight were carried out at the end of exposure from the control fish. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 10.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks:
- No mortalities observed over the course of the 96 hours exposure at threshold test concentration
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- No mortalities observed over the course of the 96 hours exposure at threshold test concentration
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 10.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other:
- Remarks:
- Sub-lethal physical and behavioural observations
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other:
- Remarks:
- Sub-lethal physical and behavioural observations
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No mortalities observed over the course of the 96 hours exposure at threshold concentration
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No mortalities observed over the course of the 96 hours exposure at threshold concentration
- Details on results:
- The LC0 and NOEC corresponds to the nominal Threshold Concentration ≥ 12.0 mg/L and the geometric mean measured Threshold Concentration ≥ 10.7 mg test item/L No mortalities or sub-lethal effects were observed over the course of the 96 hours exposure at threshold concentration : 96 hour LC50 > 12.0 mg/L (nominal) / 10.7 mg/L (measured).
Validity Criteria :
• The O2 saturation was 60 % (measured range: 78 – 100 %).
• The mortality in the control was 0 %.
• The pH-value in the control group did not deviate by more than one unit over the test period (measured range: 7.32 – 7.73). - Results with reference substance (positive control):
- Not applicable - no Reference Toxicity standard used.
- Validity criteria fulfilled:
- yes
- Conclusions:
- A semi-static test was performed as a threshold concentration test with a concentration 12 mg/L, corresponding to the geometric mean measured test item concentration of 10.7 mg/L. The threshold concentration of 12 mg/L (nominal) was chosen based on the lowest EC50 value derived from the OECD 201 and OECD 202 studies on FRESKOMENTHE and corresponds to the 72 hour EC50 determined for yield inhibition of algae.
No mortality nor sub lethal effects were observed for fish exposed to either the control nor the threshold concentration throughout the 96 hour duration of the study. The LC100 and LC50 are > 12.0 mg/L (nominal) and the LC0 and NOEC are both ≥ 12.0 mg/L (nominal).
All effect levels are given based on the nominal and geometric mean measured limit concentration of the test item FRESKOMENTHE. The limit concentration of the test item was found to have no lethal and sub lethal effects on zebrafish.
In conclusion, the LC0 and NOEC corresponds to the nominal Threshold Concentration ≥ 12.0 mg/L and the geometric mean measured Threshold Concentration ≥ 10.7 mg test item/L. - Executive summary:
A semi-static test was performed as a threshold concentration test with a concentration 12 mg/L, corresponding to the geometric mean measured test item concentration of 10.7 mg/L. The threshold concentration of 12 mg/L (nominal) was chosen based on the lowest EC50 value derived from the OECD 201 and OECD 202 studies on FRESKOMENTHE and corresponds to the 72 hour EC50 determined for yield inhibition of algae.
No mortality nor sub lethal effects were observed for fish exposed to either the control nor the threshold concentration throughout the 96 hour duration of the study. The LC100 and LC50 are > 12.0 mg/L (nominal) and the LC0 and NOEC are both ≥ 12.0 mg/L (nominal).
All effect levels are given based on the nominal and geometric mean measured limit concentration of the test item FRESKOMENTHE. The limit concentration of the test item was found to have no lethal and sub lethal effects on zebrafish.
In conclusion, the LC0 and NOEC corresponds to the nominal Threshold Concentration ≥ 12.0 mg/L and the geometric mean measured Threshold Concentration ≥ 10.7 mg test item/L.
Reference
Description of key information
A semi-static test was performed as a threshold concentration test with a concentration 12 mg/L, corresponding to the geometric mean measured test item concentration of 10.7 mg/L. The threshold concentration of 12 mg/L (nominal) was chosen based on the lowest EC50 value derived from the OECD 201 and OECD 202 studies on FRESKOMENTHE and corresponds to the 72 hour EC50 determined for yield inhibition of algae.
No mortality nor sub lethal effects were observed for fish exposed to either the control nor the threshold concentration throughout the 96 hour duration of the study. The LC100 and LC50 are > 12.0 mg/L (nominal) and the LC0 and NOEC are both ≥ 12.0 mg/L (nominal).
All effect levels are given based on the nominal and geometric mean measured limit concentration of the test item FRESKOMENTHE. The limit concentration of the test item was found to have no lethal and sub lethal effects on zebrafish.
In conclusion, the LC0 and NOEC corresponds to the nominal Threshold Concentration ≥ 12.0 mg/L and the geometric mean measured Threshold Concentration ≥ 10.7 mg test item/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 12 mg/L
Additional information
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.
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