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EC number: 206-596-0 | CAS number: 355-93-1
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- In-life phase from July 13, 2016 to August 3, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 2012
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM E 1193-97: Standard Guide for Conducting Daphnia magna Life-Cycle Toxicity Tests
- Version / remarks:
- 2004
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Identified as: Octafluoropentyl Methacrylate (OFPMA)
Purity: 99.7% - Analytical monitoring:
- yes
- Details on sampling:
- Samples were analyzed for the concentration of OFPMA as well as the degradate octafluoro-1-pentanol (OFPol), to monitor the degradation of OFPMA in the test solutions. The samples were collected volumetrically from mid-depth, placed in glass scintillation vials and stored refrigerated, and processed immediately for analysis.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
Test solutions were prepared daily during the test.
Each day a primary stock solution was prepared at a nominal concentration of 100 mg/L in pH adjusted UV sterilized well water.
A calculated amount of test substance was rinsed into a glass aspirator bottle, equipped with draining spigot at the bottom of the bottle, to achieve a final stock concentration of 100 mg/L. The bottle was nearly filled with the dilution water to minimize headspace to reduce a possibility of loss of material through volatility. The bottle mouth was wrapped with Parafilm™, stirred overnight using a stir bar and a stir plate. At the end of the stirring, the solution was filtered through a 0.2 µm membrane filter.
The filtrate was used as the highest test solution and as a primary stock solution to prepare the four additional test solutions. Test chambers were closed following filling in an attempt to minimize loss due to volatilization.
All test solutions appeared clear and colorless with no visible precipitate noted. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Daphnia magna
- Source: obtained from cultures maintained by EAG Laboratories, Easton, Maryland
- Age of parental stock: neonates less than 24 hours old
- Feeding during test: Yes
- Food type: a mixture of yeast, cereal grass media and trout chow (YCT), supplemented with a vitamin stock solution and a suspension of the freshwater green alga, Raphidocelis subcapitata
- Amount: approximately 0.24 to 0.27 mg C/daphnid/day
- Frequency: Daily
ACCLIMATION
- Acclimation period: 27 days prior to collection of the juveniles for testing
- Acclimation conditions: same as test
- Type and amount of food: a mixture of yeast, cereal grass media and trout chow (YCT), supplemented with a vitamin stock solution and a suspension of the freshwater green alga, Raphidocelis subcapitata
- Feeding frequency: daily
- Health during acclimation: no signs of disease or stress and no ephippia
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
To initiate the test, the juvenile daphnids were collected from the cultures and indiscriminately transferred one or two at a time to transfer chambers until each chamber contained 5 daphnids. Each group of neonates then was impartially assigned to a control or treatment group and individual neonates were transferred to each test chamber to initiate the test. All transfers were made below the water surface using wide-bore pipettes. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 119 - 120 mg CaCO3/L
- Test temperature:
- 19.1 - 20.9 °C
- pH:
- 6.5 - 7.2
- Dissolved oxygen:
- 5.4 - 9.1 mg O2/L
- Conductivity:
- 332 - 348 µS/cm
- Nominal and measured concentrations:
- Nominal: 2.6, 6.4, 16, 40, 100 mg/L
Time-Weighted Mean Measured: 0.22, 0.70, 1.8, 4.8, 16 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Type: closed
- Material, size, headspace, fill volume: Approximately 125-mL aliquots of the test solutions were added to each test chamber
- Aeration: None during study
- Renewal rate of test solution: Daily
- No. of organisms per vessel: One
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 20
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water from approximately 40 meters deep located on the EAG Laboratories-Easton site
- Total organic carbon: < 1 mg C/L
- Metals: Periodic analyses included in report
- Pesticides: Periodic analyses included in report
OTHER TEST CONDITIONS
- Adjustment of pH: One day prior to the preparation of the test solutions, the pH of two batches of well water (for a total of 16 or 18 L) was adjusted to a final pH of approximately 6.5 to 6.6 using concentrated phosphoric acid (H3PO4). The two batches of pH adjusted well water were then combined and stirred overnight and the final pH was measured prior to use and ranged from 6.3 to 6.9.
- Photoperiod: 16 hours of light and 8 hours of darkness; 30-minute transition period
- Light intensity: 1010 lux at the surface of the water (based on re-measured value)
EFFECT PARAMETERS MEASURED:
First-generation daphnids were observed daily during the test for immobility, the onset of reproduction, and clinical signs of toxicity.
Following the onset of reproduction, the numbers of second-generation daphnids were counted daily at each renewal, and at test termination (Day 21).
Body lengths and dry weights of the surviving first-generation daphnids were measured at the end of the exposure period.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.5
- Range finding study test concentrations: nominal concentrations of 0.81, 2.7, 9.0, 30 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 16 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Highest concentration tested (100 mg/L nominal)
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 6.6 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 16 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Highest concentration tested (100 mg/L nominal)
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- dry weight
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 4.8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- dry weight
- Duration:
- 21 d
- Dose descriptor:
- other: maximum acceptable toxicant concentration (MATC)
- Effect conc.:
- 2.9 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- dry weight
- Details on results:
- - Observations on body length and weight: Statistically significant reduction in mean total length and dry weight of live neonates reported at 4.8 and 16 mg/L (measured TWA) test concentrations.
- Mortality of control: Only 5% of parent daphnids in the controls were immobilized
- Other adverse effects control: None reported
- Abnormal responses: None reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no evidence of precipitation observed - Reported statistics and error estimates:
- Test endpoints analyzed statistically for first-generation daphnids were:
- survival;
- reproduction; and
- growth (length and dry weight).
Reproduction endpoint was analyzed as
- the number of live young produced per 21-day surviving adult; and
- the number of live young produced per parent animal alive at the beginning of the test excluding parental accidental mortality and/or inadvertent mortality.
Survival data was considered to be discrete-variable data, while reproduction and growth data were considered continuous-variable data.
Discrete-variable data were analyzed using Chi-square and Fisher’s Exact test to identify treatment groups that showed a statistically significant difference (α = 0.05) from the control.
Continuous-variable data were evaluated for normality using Shapiro-Wilk’s or Chi-square test and for homogeneity of variance using Levene’s test (α = 0.01). When the data of the growth endpoint passed the assumptions of normality and homogeneity, those treatments that were significantly different from the control means were identified using Dunnett’s test (α = 0.05). When the reproduction data failed the assumptions of normality and/or homogeneity and data correction (log transformation) did not correct the problem, those treatments that were significantly different from the control means were identified using a non-parametric method (Wilcoxon/Bonferroni-Holm test, α = 0.05). All statistical tests were performed using a personal computer with TOXSTAT, SAS or CETIS software. - Validity criteria fulfilled:
- yes
- Conclusions:
- The chronic toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and the most sensitive end-point was growth measured as dry weight. The 21-day NOEC is 1.8 mg/L, the LOEC is 4.8 mg/L, and the Maximum Acceptable Toxicant Concentration (MATC) is 2.9 mg/L based on the time-weighted mean measured text concentrations.
- Executive summary:
A GLP-compliant study according to OECD Guideline 211 was conducted to assess the chronic life-cycle toxicity of octafluoropentyl methacrylate to Daphnia magna. Following range-finding tests, ten daphnids per test concentration were exposed to dilutions of a saturated solution of test item (100 mg/L nominal) with time-weighted mean measured concentration of 0.22, 0.70, 1.8, 4.8, 16 mg/L for 21 days at approximately 20 °C under semi-static conditions within a closed system. The test solutions were renewed daily. First-generation daphnids were observed daily during the test for immobility, the onset of reproduction, and clinical signs of toxicity. Following the onset of reproduction, the numbers of second-generation daphnids were counted daily at each renewal, and at test termination (Day 21). Body lengths and dry weights of the surviving first-generation daphnids were measured at the end of the exposure period.
There was no statistically significant treatment-related effect on survival; the NOEC for survival is the highest concentration tested 16 mg/L (100 mg/L nominal). There was a statistically significant decrease in mean neonate production per surviving adult in the 16 mg/L treatment group in comparison to the negative control. The EC10 (reproduction) was 6.6 mg/L and the EC50 (reproduction) was 8.0 mg/L.
Growth of surviving first-generation daphnids, measured as dry weight, was the most sensitive biological endpoint measured in this study. Daphnids exposed to OFPMA at concentrations ≥4.8 mg/L had statistically significant reductions in dry weight in comparison to the negative control. Consequently, the NOEC, based on growth, was 1.8 mg/L, the LOEC was 4.8 mg/L and the Maximum Acceptable Toxicant Concentration (MATC) was calculated to be 2.9 mg/L.
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- In-life phase from July 6, 2016 to July 27, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 2012
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM E 1193-97: Standard Guide for Conducting Daphnia magna Life-Cycle Toxicity Tests
- Version / remarks:
- 2004
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Identified as: Octafluoropentanol (OFPol)
Purity: 99% - Analytical monitoring:
- yes
- Details on sampling:
- Samples were analyzed for the concentration of OFPol in the test solutions. The samples were collected volumetrically from mid-depth, placed in glass scintillation vial, and processed immediately for analysis or stored refrigerated until processed for analysis.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test solutions were prepared every 2 to 3 days (typically each Monday, Wednesday and Friday) during the test.
A calculated amount of test substance was rinsed into a glass aspirator bottle, equipped with draining spigot at the bottom of the bottle, to achieve a final stock concentration of 100 mg/L The bottle was nearly filled with the dilution water with reduced headspace to reduce a possibility of loss of material through volatility. The bottle was covered with Parafilm™ and the solution was stirred overnight using a stir bar and a stir plate. At the end of the stirring, the solution was filtered through a 0.2 µm membrane.
The filtrate was used as the highest test solution and as a primary stock solution to prepare the four additional test solutions. Test chambers were loosely covered in an attempt to minimize loss due to volatilization.
All test solutions appeared clear and colorless with no visible precipitate noted. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Daphnia magna
- Source: obtained from cultures maintained by EAG Laboratories, Easton, Maryland
- Age of parental stock: neonates less than 24 hours old
- Feeding during test: Yes
- Food type: a mixture of yeast, cereal grass media and trout chow (YCT), supplemented with a vitamin stock solution and a suspension of the freshwater green alga, Raphidocelis subcapitata
- Amount: approximately 0.6 mg C/daphnid/day
- Frequency: Daily
ACCLIMATION
- Acclimation period: 21 days prior to collection of the juveniles for testing
- Acclimation conditions: same as test
- Type and amount of food: a mixture of yeast, cereal grass media and trout chow (YCT), supplemented with a vitamin stock solution and a suspension of the freshwater green alga, Raphidocelis subcapitata
- Feeding frequency: daily
- Health during acclimation: no signs of disease or stress and no ephippia
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
To initiate the test, the juvenile daphnids were collected from the cultures and indiscriminately transferred one or two at a time to transfer chambers until each chamber contained 10 daphnids. Each group of neonates then was impartially assigned to a control or treatment group and individual neonates were transferred to each test chamber to initiate the test. All transfers were made below the water surface using wide-bore pipettes. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 142 - 143 mg CaCO3/L
- Test temperature:
- 19.5 - 20.8 °C
- pH:
- 8.0 - 8.9
- Dissolved oxygen:
- 6.7 - 9.1 mg O2/L
- Conductivity:
- 333 - 384 µS/cm
- Nominal and measured concentrations:
- Nominal: 6.3, 13, 25, 50, 100 mg/L
Time-Weighted Mean Measured: 3.7, 8.5, 17, 31, 73 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Type: closed
- Material, size, headspace, fill volume: Approximately 200-mL aliquots of the test solutions were added to each test chamber
- Aeration: None during study
- Renewal rate of test solution: Test solutions were renewed every 2 - 3 days
- No. of organisms per vessel: one
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 20
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water from approximately 40 meters deep located on the EAG Laboratories-Easton site
- Total organic carbon: < 2 mg C/L
- Metals: Periodic analyses included in report
- Pesticides: Periodic analyses included in report
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours of light and 8 hours of darkness; 30-minute transition period
- Light intensity: 1022 lux
EFFECT PARAMETERS MEASURED:
Observations of each first-generation daphnid were made daily during the test for the numbers of immobile daphnids, along with any clinical signs of toxicity. The presence of eggs in the brood pouch, aborted eggs, males or ephippia also was recorded daily.
With the onset of reproduction, neonates produced by the first-generation daphnids were counted and then discarded every Monday, Wednesday and Friday during the test and at test termination.
Second-generation daphnids were also counted at the time a replicate was terminated due to a first-generation immobility.
The body length and dry weight of each surviving first-generation daphnid were measured at the end of the test.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study test concentrations: nominal concentrations of 0.14, 0.46, 1.5, 5.1 and 17 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 73 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Highest concentration tested (100 mg/L nominal)
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 73 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Highest concentration tested (100 mg/L nominal)
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 73 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks on result:
- other: Highest concentration tested (100 mg/L nominal)
- Details on results:
- No statistically significant treatment-related effects on survival, growth or reproduction reported.
no evidence of precipitation observed - Reported statistics and error estimates:
- Test endpoints analyzed statistically for first-generation daphnids were:
- survival;
- reproduction; and
- growth (length and dry weight).
Reproduction endpoint was analyzed as
- the number of live young produced per 21-day surviving adult; and
- the number of live young produced per parent animal alive at the beginning of the test excluding parental accidental mortality and/or inadvertent mortality.
Survival data was considered to be discrete-variable data, while reproduction and growth data were considered continuous-variable data.
Discrete-variable data were analyzed using Chi-square and Fisher’s Exact test to identify treatment groups that showed a statistically significant difference (α = 0.05) from the control.
Continuous-variable data were evaluated for normality using Shapiro-Wilk’s or Chi-square test and for homogeneity of variance using Levene’s test (α = 0.01). When the data of the growth endpoint passed the assumptions of normality and homogeneity, those treatments that were significantly different from the control means were identified using Dunnett’s test (α = 0.05). When the reproduction data failed the assumptions of normality and/or homogeneity and data correction (log transformation) did not correct the problem, those treatments that were significantly different from the control means were identified using a non-parametric method (Wilcoxon/Bonferroni-Holm test, α = 0.05). All statistical tests were performed using a personal computer with TOXSTAT, SAS or CETIS software. - Validity criteria fulfilled:
- yes
- Conclusions:
- The chronic toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated. There was no toxicity reported based on survival, growth or reproduction for the highest test time-weight mean measured concentration of 73 mg/L (100 mg/L nominal).
- Executive summary:
A GLP-compliant study according to OECD Guideline 211 was conducted to assess the chronic life-cycle toxicity of octafluoro-1-pentanol to Daphnia magna. Following range-finding tests, ten daphnids per test concentration were exposed to dilutions of a saturated solution of test item with time-weight mean measured concentration of 3.7, 8.5, 17, 31, 73 mg/L for 21 days at approximately 20 °C under semi-static conditions within a closed system. The test solutions were renewed every 2-3 days. Observations of each first-generation daphnid were made daily during the test for the numbers of immobile daphnids, along with any clinical signs of toxicity. The presence of eggs in the brood pouch, aborted eggs, males or ephippia also was recorded daily. With the onset of reproduction, neonates produced by the first-generation daphnids were counted and then discarded every Monday, Wednesday and Friday during the test and at test termination. Second-generation daphnids were also counted at the time a replicate was terminated due to a first-generation immobility. The body length and dry weight of each surviving first-generation daphnid were measured at the end of the test.
There was no statistically significant treatment-related effect on survival, growth or reproduction. The 21-day NOEC is the maximum test concentration of 73 mg/L (i.e., 100 mg/L nominal) for all observation endpoints.
Referenceopen allclose all
The following criteria were used to judge the validity of the test:
1) the percentage of parent daphnids in the controls that appear to be immobilized, stressed or diseased at the end of the test in the negative control will be ≤20%, it was 5%;
2) the mean number of living offspring produced per parent control animal surviving at the end of the test in the negative control will be ≥60, it was 95.3%;
3) no ephippia were produced by control animals; and
4) among replicate test chambers of a treatment concentration, measured concentrations of the test substance should not vary more than 20%. The measured concentrations of the test substance OFPMA among replicate test chambers over each renewal period varied more than 20%, as anticipated, due to degradation of OFPMA to OFPoL. However, the initial measured concentrations at each renewal did not vary more than 20% establishing the consistency of initial exposures at each exposure level and the combined total concentration OFPMA and OFPoL averaged >80% of the target concentration. The time-weighted mean measured concentration for OFPMA during renewal periods was calculated, and used in effect determinations, as indicated in OECD TG 211 Annex 6.
In view of the totality of the results, the study was judged to be valid.
The following criteria were used to judge the validity of the test:
1) the percentage of parent daphnids in the controls that appear to be immobilized, stressed or diseased at the end of the test in the negative control will be ≤20%, it was 9%;
2) the mean number of living offspring produced per parent control animal surviving at the end of the test in the negative control will be ≥60, it was 276;
3) no ephippia were produced by control animals; and
4) among replicate test chambers of a treatment concentration, measured concentrations of the test substance should not vary more than 20%. Because the measured concentrations of the test substance among replicate test chambers varied more than 20%, the time-weighted mean measured concentration during renewal periods was calculated and reported as indicated in OECD TG 211 Annex 6. In addition, the initial measured concentrations at each renewal did not vary more than 20% establishing the consistency of initial exposures at each exposure level.
In view of the totality of the results, the study was judged to be valid.
Description of key information
A GLP-compliant study according to OECD Guideline 211 was conducted to assess the chronic life-cycle toxicity of octafluoropentyl methacrylate to Daphnia magna. Following range-finding tests, ten daphnids per test concentration were exposed to dilutions of a saturated solution of test item (100 mg/L nominal) with time-weighted mean measured concentration of 0.22, 0.70, 1.8, 4.8, 16 mg/L for 21 days at approximately 20 °C under semi-static conditions within a closed system. The test solutions were renewed daily. First-generation daphnids were observed daily during the test for immobility, the onset of reproduction, and clinical signs of toxicity. Following the onset of reproduction, the numbers of second-generation daphnids were counted daily at each renewal, and at test termination (Day 21). Body lengths and dry weights of the surviving first-generation daphnids were measured at the end of the exposure period.
There was no statistically significant treatment-related effect on survival; the NOEC for survival is the highest concentration tested 16 mg/L (100 mg/L nominal). There was a statistically significant decrease in mean neonate production per surviving adult in the 16 mg/L treatment group in comparison to the negative control. The EC10 (reproduction) was 6.6 mg/L and the EC50 (reproduction) was 8.0 mg/L. Growth of surviving first-generation daphnids, measured as dry weight, was the most sensitive biological endpoint measured in this study. Daphnids exposed to OFPMA at concentrations ≥4.8 mg/L had statistically significant reductions in dry weight in comparison to the negative control. Consequently, the NOEC, based on growth, was 1.8 mg/L, the LOEC was 4.8 mg/L and the Maximum Acceptable Toxicant Concentration (MATC) was calculated to be 2.9 mg/L.
For the purposes of a chemical safety assessment, the EC10 value of 6.6 mg/L was selected as per Technical Guidance R.10 which indicates daphnia reproduction as the key endpoint.
A similar GLP-compliant study according to OECD Guideline 211 was conducted to assess the chronic life-cycle toxicity of the OFPMA degradation product octafluoro-1-pentanol to Daphnia magna with time-weight mean measured concentration of 3.7, 8.5, 17, 31, 73 mg/L for 21 days. There was no statistically significant treatment-related effect on survival, growth or reproduction. The 21-day NOEC for the OFPMA degradation product octafluoro-1-pentanol is the maximum test concentration of 73 mg/L (i.e., 100 mg/L nominal) for all observation endpoints.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6.6 mg/L
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