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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Remarks:
None reported
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
The substance is an analogue for the group of substances, referred to as sulphonic acid, petroleum derived calcium salt in the HERTG's Test Plan for Alkaryl Sulfonates Category.
Analytical monitoring:
yes
Details on sampling:
Total organic carbon (TOC) measurements of each freshly prepared test solution and control and after 24 hours on test just before daily renewal with fresh test solution.
Vehicle:
no
Details on test solutions:
Individual water accommodated fractions (WAFs) were prepared for each daily renewal of the 10,000 mg/L test level.
A measured weight of test material was added to a measured volume of dilution water (15 L) in a glass vessel and stirred for 16 to 24 hour.
Stirring was accomplished using a Telfon coated magnetic stir bar.
Following the mixing period, the test solution were allowed to stand for 2 hours before the water phase was removed.
The water phase was siphoned from the middle of the vessels and was used for the toxicity test.

Dilution water was natural seawater collected from Cape Cod Canal, Bourne, Massachusetts. Water was filtered through a 0.5 micron polypropylene core filter and then activated carbon. Water was stored under constant aeration for 1-4 days prior to use.

No undissolved test material was reported on the surface of the test vessels during the entire toxicity test.
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Commercial supplier in New Hampshire
- Age at study initiation: 14 days old
- Length at study initiation: Average 12 mm, range 10-15 mm, n=30
- Weight at study initiation: Average 0.04 g, range 0.004-0.11 g, n=30
- Feeding during test: The fish were not fed during the test
- Loading biomass: 0.08 g biomass/L

ACCLIMATION
- Acclimation period: Fish were held for a minimum of 7 days prior to testing
- Pretreatment: None
Test type:
other: Static renewal
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not reported.
Hardness:
Not relevant.
Test temperature:
22 to 23°C
pH:
7.7 to 8.1
Dissolved oxygen:
6.3 - 7.2 mg/L
Salinity:
32 - 34 ppt
Nominal and measured concentrations:
Mean measured TOC levels in the control and 10,000 mg/L WAF test level were 4.1 mg/L (range 2.3 to 7.9) and 10.2 mg/L (range 6.4 to 15.0), respectively.
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 L vessel
- Renewal rate of test solution (frequency/flow rate): About 90% of the test solution in each vessel renewed daily after 24, 48 and 72 hours.
- No. of organisms per vessel: Ten
- No. of vessels per concentration (replicates): Two

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater collected from Cape Cod Canal, Bourne, Massachusetts

EFFECT PARAMETERS MEASURED: Mortality and signs of toxicity

TEST CONCENTRATIONS
- Test concentrations: Control and 10,000 mg/L WAF loading rate
Reference substance (positive control):
yes
Remarks:
sodium lauryl sulfate
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 other: mg/L WAF
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 10 000 other: mg/L WAF
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Details on results:
Control mortality did not exceed the test validity criterion (i.e. < 10 % mortality in controls).
No mortality or signs of toxicity were noted in either the control or the 10000 mg/L WAF treatment throughout the test.
Results with reference substance (positive control):
96 hour LC50 was 1.2 mg/L
Reported statistics and error estimates:
Statistical analysis of the data was not warranted on the basis that no mortality occurred in this study.
Validity criteria fulfilled:
yes
Remarks:
Scientifically validity criteria were met.
Conclusions:
The report describes a valid guideline study with GLP compliance. The test substance (CAS 61789-86-4) was found to be not toxic for Sheepshead minnow (Cyprinidon variegatus) at a loading of 10000 mg/L nominal WAF.
Executive summary:

In a 96-hour acute toxicity study, Sheepshead minnow (Cyprinidon variegatus) were exposed to sulphonic acid, petroleum derived calcium salt (CAS 61789 -86 -4) at nominal concentrations of 0 and 10,000 mg/L WAF under static renewal conditions.  The 96-hour LL50was >10,000 mg/L nominal WAF. No signs of toxicity were noted.

 

This toxicity study is classified as acceptable and satisfies the guideline requirement for a fish acute toxicity study.

 

Results Synopsis

 

Test organism size/age (mean wet weight or length): 14 days old, average length 12 mm, average weight 0.04 g

Test Type: Static renewal

 

LL50:  >10,000 mg/L nominal WAF

LL0:  10,000 mg/L nominal WAF

Endpoint(s) Effected: None

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Remarks:
None reported
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
The substance tested is an analog for the group of substances referred to as C20-C24 alkyl calcium salt overbased derivative in the HERTG's Test Plan for All Sulfonates Category.
Analytical monitoring:
yes
Details on sampling:
Total organic carbon (TOC) measurements of each freshly prepared test solution and control and after 24-hours on test just before daily renewal with fresh test solution.
Vehicle:
no
Details on test solutions:
Individual water accommodated fractions (WAFs) were prepared for each daily renewal of the 10,000 mg/L test level.
A measured weight of test material was added to a measured volume of dilution water (15 L) in a glass vessel and stirred for 16 to 24 hour.
Stirring was accomplished using a Telfon coated magnetic stir bar.
Following the mixing period, the test solution were allowed to stand for 2 hours before the water phase was removed.
The water phase was siphoned from the middle of the vessels and was used for the toxicity test.

Dilution water was natural seawater collected from Cape Cod Canal, Bourne, Massachusetts. Water was filtered through a 0.5 micron polypropylene core filter and then activated carbon. Water was stored under constant aeration for 1-4 days prior to use.

No undissolved test material was reported on the surface of the test vessels during the entire toxicity test.
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Commercial supplier in New Hampshire
- Age at study initiation: 10 to 15 days old
- Length at study initiation: Average 11 mm, range 10-13 mm, n=30
- Weight at study initiation: Average 0.028 g, range 0.02-0.05 g, n=30
- Feeding during test: The fish were not fed during the test
- Loading biomass: 0.056 g biomass/L

ACCLIMATION
- Acclimation period: Fish were held for a minimum of 6 days prior to testing
- Pretreatment: None
Test type:
other: Static renewal
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not reported
Hardness:
Not relevant
Test temperature:
22 to 23°C
pH:
7.9 to 8.1
Dissolved oxygen:
5.5 mg/L to above 100 % saturation (7.2 mg/L)
Salinity:
32 - 34 ppt
Nominal and measured concentrations:
Mean measured TOC levels in the control and 10,000 mg/L WAF test level were 3.0 mg/L (range 1.2 to 4.4) and 6.4 mg/L (range 5.0 to 7.9), respectively.
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 L vessel
- Renewal rate of test solution (frequency/flow rate): About 90 % of the test solution in each vessel renewed daily after 24, 48 and 72 hours.
- No. of organisms per vessel: Ten
- No. of vessels per concentration (replicates): Two

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater collected from Cape Cod Canal, Bourne, Massachusetts

EFFECT PARAMETERS MEASURED: Mortality and signs of toxicity

TEST CONCENTRATIONS
- Test concentrations: Control and 10,000 mg/L WAF loading rate
Reference substance (positive control):
yes
Remarks:
Sodium lauryl sulfate (SLS)
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 other: mg/L WAF
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 10 000 other: mg/L WAF
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Details on results:
Control mortality did not exceed the test validity criterion (i.e. <10 % mortality in controls).
No mortality or signs of toxicity were noted in either the control or the 10,000 mg/L WAF treatment throughout the test.
Results with reference substance (positive control):
96 hour LC50 was 1.2 mg/L
Reported statistics and error estimates:
Statistical analysis of the data was not warranted on the basis that no mortality occurred in this study.
Validity criteria fulfilled:
yes
Remarks:
Scientifically validity criteria were met.
Conclusions:
The report describes a valid guideline study with GLP compliance. The test substance (CAS 70024-71-4) was found to be not toxic for Sheepshead minnow (Cyprinidon variegatus) at a loading of 10000 mg/L nominal WAF.
Executive summary:

Cyprinodon variegatus (Sheepshead minnow) was used as saltwater representative fish in an experiment in order to determine the toxicity potential of the calcium sulfonate read-across substance (CAS 70024-71-4) (Nicholson, 1986b). The acclimatisation period was about 13 days and the biomass loading rate was 0.056 g/L. A control group was included and a single concentration of 10000 mg/L WAF was applied (limit test). The exposure time was 96 h. Sodium lauryl sulfate was used as reference substance, revealing a LC50(96h) of 1.2 mg/L. Neither in the control nor in any of the treatment groups, mortality or signs of toxicity were recorded. Therefore, the LL50(96h) is > 10000 mg/L WAF with a corresponding NOELR of 10000 mg/L WAF. No statistical analysis of data was warranted due to the fact that the test substance was found to be non-toxic under the applied conditions.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Responsibility of the study data lies on the master dossier for the main read-across substance. The original study was not handed out.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)
Remarks:
No details available.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
- Physical state: brown, slightly viscous liquid
- Storage conditions: room temperature in the dark
Analytical monitoring:
no
Details on sampling:
Water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. pH and dissolved oxygen concentrations were measured using a WTW pH/Oxi 340I pH and dissolved oxygen meter, and the temperature was measured using a Hanna Instruments HI 93510 digital thermometer
Vehicle:
no
Details on test solutions:
- Method: An amount of test material (2100 mg) was added, via syringe, to the surface of 21 litres of dechlorinated tap water. The test solution was stirred for 24 hours using a magnetic stirrer using a stirring rate such that a slight dimple was formed on the surface. After stirring the mixture was allowed to stand for 1 hour. A wide bore glass tube, covered at one end with Parafilm was submerged into the vessel, sealed end down, to a depth of 5 cm for from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Parafilm seal. The aqueous phase was removed by mid-depth siphoning (the first 75 - 100 mL discarded).
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Microscopic inspection of the WAF after filtering showed no micro-dispersions or undissolved test material to be present
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, Yorkshire, UK
- Age at study initiation: Juvenile
- Length at study initiation: mean standard length 4.7 cm (SD = 0.2)
- Weight at study initiation: mean weight 1.54 g (SD = 0.35)
- Feeding during test: Fish were not fed during the test

ACCLIMATION
- Acclimation period: 2004-12-08 - 2004-12-20
- Acclimation conditions: Water temperature controlled at 14 °C, dissolved oxygen concentration of greater than or equal to 10.1 mg O2/L
- Feeding frequency: Commercial trout pellets which were discontinued 24 hours prior to the test
- Health during acclimation (any mortality observed): There was no mortality for 7 days prior to the initiation of the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period reported.
Hardness:
Approx. 100 mg CaCO3/L
Test temperature:
Control: 12.7 - 13.0 °C
100 mg/L: 12.7 - 13.0 °C
pH:
Control: 7.7 - 8.2
100 mg/L: 7.7 - 8.2
Dissolved oxygen:
Control: 10.0 - 10.3 mg O2/L; ASV (Air Saturation Value): 95 - 98 %
100 mg/L: 10.0 - 10.2 mg O2/L; ASV (Air Saturation Value): 95 - 97 %
Salinity:
Not applicable.
Nominal and measured concentrations:
Nominal: 100 mg/L WAF
Details on test conditions:
TEST SYSTEM
- Test vessel: 20 litre glass vessel, covered to reduce evaporation
- Renewal rate of test solution: Daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.77 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated by passing through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex water softener). The water was then passed through a series of computer controlled plate heat exchangers to achieve the required temperature.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark with 20 minute transition periods for dawn and dusk

EFFECT PARAMETERS MEASURED: Mortality

RANGE FINDING STUDY
- Test concentrations: 0, 10 and 100 mg/L nominal WAF loading rates
- Results used to determine the conditions for the definitive study: No mortalities or sub-lethal affects occurred at 10 or 100 mg/L WAF loading rates.
Reference substance (positive control):
no
Remarks:
Not mandatory under the applied guideline.
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF loading rate
Basis for effect:
mortality (fish)
Details on results:
No mortalities and no sub-lethal effects were noted at 100 mg/L WAF loading rate.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
None reported.
Validity criteria fulfilled:
yes
Remarks:
Scientifically validity criteria were met.
Conclusions:
The report describes a valid guideline study with GLP compliance. The test substance (CAS 115733-09-0) was found to be not toxic for Oncorhynchus mykiss up to concentrations of 100 mg/L.
Executive summary:

In a 96-hour acute toxicity study, juvenile Rainbow trouts (Oncorhynchus mykiss) were exposed to benzenesulfonic acid, C14-24-branched and linear alkyl derivs., calcium salts (CAS 115733-09-0) at nominal concentrations of 0 (control group) and 100 mg/L WAF loading rate under semi-static conditions. Water Accommodated Fractions (WAFs) were prepared due to the low water solubility of the test substance. Water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. No mortalities and no sublethal effects were noted at the highest tested concentration, thus the LL50(96h) is reported to be > 100 mg/L WAF with a corresponding NOELR of 100 mg/L WAF.

Description of key information

Acute toxicity to freshwater fish:
No toxicity observed even at highest concentration level tested.
RA_CAS115733-09-0_OECD 203_Oncorhynchus mykiss: LL50(96h) > 100 mg/L WAF


Acute toxicity to saltwater fish:
No toxicity observed even at highest concentration level tested.

RA_CAS70024-71-4_OECD 203_Cyprinodon variegatus: LL50 (96h) > 10000 mg/L WAF,

RA_CAS61789-86-4_OECD 203_Cyprinodon variegatus: LL50 (96h) > 10000 mg/L WAF

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Marine water fish

Marine water fish
Effect concentration:
10 000 mg/L

Additional information

General considerations

The acute toxicity to fish was investigated for different analogues structures of the barium sulfonate target substance (Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts). For the substance itself, no experimental data are available. Since all substances used belong to the same chemical group, aryl-alkyl sulfonates, the same behaviour and toxicity potential can be expected. Calcium sulfonate read-across substance (CAS 115733-09-0), calcium sulfonate read-across substance (CAS 61789 -86 -4) and calcium sulfonate read-across substance (CAS 70024-71-4), were used to fulfil the endpoint of short-term toxicity to freshwater fish: For the detailed procedure of the read-across principle and justifications, please refer to the separate Read-Across Statement (Chemservice S.A., 2018).

Acute toxicity to freshwater fish

In a 96-hour key study, juvenile Rainbow trouts (Oncorhynchus mykiss) were exposed to the calcium sulfonate read-across substance (CAS 115733-09-0) at nominal concentrations of 0 (control group) and 100 mg/L WAF loading rate under semi-static conditions (Goodband, 2005).

The experiment was conducted in accordance to OECD Guideline 203 and under GLP compliance. Based on the intrinsic properties of the used substance, Water Accommodated Fractions (WAFs) were prepared for testing. Physico-chemical parameters (i.e. water temperature, pH and dissolved oxygen concentration (DOC)) were recorded daily throughout the test duration of 96 h. No mortalities and no sublethal effects were noted at the highest tested concentration, thus the LL50(96h) is reported to be > 100 mg/L WAF with a corresponding NOELR of 100 mg/L WAF.

Acute toxicity to saltwater fish

Cyprinodon variegatus (Sheepshead minnow) was used as saltwater representative fish in an experiment in order to determine the toxicity potential of the calcium sulfonate read-across substance (CAS 70024-71-4) in a key study by Nicholson (1986b). The acclimatisation period was about 13 days and the biomass loading rate was 0.056 g/L. A control group was included and a single concentration of 10000 mg/L WAF was applied (limit test). The exposure time was 96 h. Sodium lauryl sulfate was used as reference substance, revealing a LC50 (96h) of 1.2 mg/L. Neither in the control nor in any of the treatment groups, mortality or signs of toxicity were recorded. Therefore, the LL50 (96h) is > 10000 mg/L WAF with a corresponding NOELR of 10000 mg/L WAF. No statistical analysis of data was warranted due to the fact that the test substance was found to be non-toxic under the applied conditions.

In a further key study (Nicholson, 1986a), calcium sulfonate read-across substance (CAS 61789-86-4) was tested under same test conditions (i.e. Shepshead minnow; 96 h exposure according to OECD Guideline 203; single concentration level of 10000 mg/L WAF). Again, no toxic effects were observed at this concentration level. Hence, the LL50(96h) is > 10000 mg/L WAF, whereas NOELR amounts to 10000 mg/L WAF.

Conclusion:

No toxic effects observed in all acute fish studies even at the highest concentration levels tested. The weight-of-evidence indicate that the lower NOECs for O. mykiss are not an indicator of toxicity per se, but are the result of dose selection.