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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 July 2014 to 15 August 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles
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
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
Hygroscopic: Not indicated
Volatile: Not indicated
Specific Gravity / Density: <800 kg/m3 at 15 C
Stability in water: Not indicated
Solubility in water: Insoluble
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all
- Sampling method: Approximately 50 ml from the approximate centre of the test vessels. The sample vessels were completely filled and closed airtight.
- Sample storage conditions before analysis: Samples were stored in a refrigerator until analysis.
Vehicle:
no
Details on test solutions:
Preparation was performed in closed vessels with a tap. The headspace was reduced to a minimum. Individual loading rate of 100 mg/l was prepared. A 1-day period of magnetic stirring was applied. During the stirring period care was taken to prevent the formation of an emulsion. Therefore, the vortex was in all cases less than 10% of the height of the medium, preventing the test substance being pulled down and hitting the stirring bar. The vortex was similar in all vessels. At the end of the stirring a floating layer and droplets of the test substance suspended in the solution were observed in the vessels. After a 1-hour settlement period the aqueous WAFs were collected using a tap at the bottom of the vessel and used as test concentrations (a small volume of the WAF used to flush the tap was discarded). A macroscopic observation of the final test solutions revealed that they were all colorless and free of undissolved material.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Length at study initiation (mean and SD): 2.2 ± 0.2 cm
- Weight at study initiation (mean and SD): 0.26 ± 0.08 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: no

ACCLIMATION
- Acclimation period: Fish were hold in a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 0.5 unit and 0.5°C. Therefore, no acclimation was needed.

QUARANTINE (wild caught)
- Duration: at least 12 days
- Health/mortality: less than 5% during the seven days prior to the start of the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
180 mg/l expressed as CaCO3
Test temperature:
22-23 C
pH:
7.2-7.9
Dissolved oxygen:
6.4-9.0
Salinity:
not measured
Nominal and measured concentrations:
control and a Water Accommodated Fraction (WAF) prepared at a loading rate of 100 mg/l

TOC-concentrations at the WAF prepared at 100 mg/l could not be reliably determined as they were below the LOD (~1 mg TOC/l) of the equipment.
Details on test conditions:
TEST SYSTEM
- Test vessel: 3.5 L
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: all glass, 3.3 L test solution
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7 (limit test);
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 0 - no vehicle control
- Biomass loading rate: 0.55 g fish/litre, i.e.7 fish per 3.3 litres of test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : 3, 24, 48, 72 and 96h LL50

TEST CONCENTRATIONS
- Range finding study: A combined limit/range-finding test
- Test concentrations: 1.0, 10 and 100 mg/l, on the basis of this test a finial test was performed as a limit
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Duration:
3 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
24 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
48 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
72 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Details on results:
- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: 0.24 mg/l
Reported statistics and error estimates:
No LL50 could be determined because the test substance proved to be non-toxic (LL50 > maximum soluble concentration).
Validity criteria fulfilled:
yes
Conclusions:
Measured acute (short-term) toxicity data are available for Hydrocarbons, C12-C15, n-alkanes, isoalkanes, <2% aromatics (GTL Solvent GS215) to the freshwater fish Cyprinus carpio (carp). The test was conducted under semi-static conditions (daily renewal of the test media) in accordance with OECD Test Guideline 203. Appropriate modifications to the test and media preparation procedures were made to take account of the test substance containing multiple constituents, having low solubility in water and being potentially volatile. No effects on mortality of C. carpio were observed after 96 hours exposure to the test medium prepared as a water-accommodated fraction (WAF) at a loading rate of 100 mg/l; 96-hour LL50 >100 mg/l, NOELR ≥100 mg/l. TOC concentrations were analysed in samples taken from the control and WAF prepared at 100 mg/l. In all cases the concentrations were below the limit of detection of the method (1.0 mg/l). The results of the test are considered to be reliable.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
04 August 2014 to 08 August 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
This study has been performed according to OECD and/or EC guidelines and according to GLP principles
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
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Hygroscopic: Not indicated
Volatile: Not indicated
Specific Gravity / Density: <800 kg/m3 at 15 C
Stability in water: Not indicated
Solubility in water: Insoluble
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all
- Sampling method: Approximately 50 ml from the approximate centre of the test vessels. The sample vessels were completely filled and closed airtight.
- Sample storage conditions before analysis: Samples were stored in a refrigerator until analysis.
Vehicle:
no
Details on test solutions:
Preparation was performed in closed vessels with a tap. The headspace was reduced to a minimum. Individual loading rates of 1.0, 10 and 100 mg/l were prepared. A 1-day period of magnetic stirring was applied. During the stirring period care was taken to prevent the formation of an emulsion. Therefore, the vortex was in all cases less than 10% of the height of the medium, preventing the test substance being pulled down and hitting the stirring bar. The vortex was similar in all vessels. At the end of the stirring a floating layer and droplets of the test substance suspended in the solution were observed in the vessels. After a 1-hour settlement period the aqueous WAFs were collected using a tap at the bottom of the vessel and used as test concentrations (a small volume of the WAF used to flush the tap was discarded). A macroscopic observation of the final test solutions revealed that they were all colorless and free of undissolved material.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Length at study initiation (mean and SD): 2.2 ± 0.1 cm
- Weight at study initiation (mean and SD): 0.22 ± 0.05 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: no

ACCLIMATION
- Acclimation period: Fish were hold in a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 0.5 unit and 0.5°C. Therefore, no acclimation was needed.

QUARANTINE (wild caught)
- Duration: at least 12 days
- Health/mortality: less than 5% during the seven days prior to the start of the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
180 mg/l expressed as CaCO3
Test temperature:
22-23 C
pH:
7.5-7.9
Dissolved oxygen:
6.3-9.1
Salinity:
not measured
Nominal and measured concentrations:
control and a Water Accommodated Fraction (WAF) prepared at a loading rate of 100 mg/l (limit test); in a combined range-finding test WAFs prepared at 1.0 and 10 mg/l were tested.

TOC-concentrations at the WAF prepared at 100 mg/l could not be reliably determined as they were below the LOD (~1 mg TOC/l) of the equipment.
Details on test conditions:
TEST SYSTEM
- Test vessel: 3.5 L
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: all glass, 3.3 L test solution
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7 (limit test); 3 per vessel for loading rates of 1.0 and 10 mg/l (combined range-finding test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 0 - no vehicle control
- Biomass loading rate:
For the control and the WAF prepared at 100 mg/l: 0.47 g fish/litre, i.e. 7 fish per 3.3 litres of test medium,
For the WAFs prepared at 1.0 and 10 mg/l: 0.20 g fish/litre, i.e. 3 fish per 3.3 litres of test medium.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : 3.25, 24, 48, 72 and 96h LL50

TEST CONCENTRATIONS
- Range finding study: The study was performed as a combined limit/range-finding test
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Duration:
3.25 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
24 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
48 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
72 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 other: mg/l loading rate Water-accommodated fraction
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Details on results:
- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: 0.24 mg/l
Reported statistics and error estimates:
No LL50 could be determined because the test substance proved to be non-toxic (LL50 > maximum soluble concentration).
Validity criteria fulfilled:
yes
Conclusions:
Measured acute (short-term) toxicity data are available for Hydrocarbons, C18-C24, isoalkanes, <2% aromatics to the freshwater fish Cyprinus carpio (carp). The test was conducted under semi-static conditions (daily renewal of the test media) in accordance with OECD Test Guideline 203. Appropriate modifications to the test and media preparation procedures were made to take account of the test substance containing multiple constituents, having low solubility in water and being potentially volatile in accordance with OECD guidance on aquatic toxicity testing of difficult substances and mixtures (OECD, 2000). No mortality or clinical effects in C. carpio were observed after 96 hours exposure to the test medium prepared as a water-accommodated fraction (WAF) at loading rates of up to 100 mg/l; 96-hour LL50 >100 mg/l, NOELR ≥100 mg/l. TOC concentrations were analysed in samples taken from the control and WAF prepared at 100 mg/l. In all cases the concentrations were below the limit of detection of the method (1.0 mg/l). The results of the test are considered to be reliable.

Description of key information

No measured data are available for Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics, therefore reliable data are read across from other GTL solvents.

Water accommodated fractions of Hydrocarbons, C12-C15, n-alkanes, isoalkanes, <2% aromatics (GS215), produced a 96-hour LL50 value of >100 mg/L in Cyprinus carpio. No mortality was observed in either the control or treatment test systems.

Water accommodated fractions of Hydrocarbons, C18-C24, isoalkanes, <2% aromatics (GS310), produced a 96-hour LL50 value of >100 mg/L in Cyprinus carpio. No mortality was observed in either the control or treatment test systems.

Key value for chemical safety assessment

Additional information