Sodium octane-1-sulphonate monohydrate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Remarks:

Study conducted in accordance with international guidelines and in accordance with GLP. All guideline criteria were met.

Adequacy of study:

key study

Study period:

29 April 2013 - 13 April 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

17 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

April 1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Commission Regulation (EC) No 761/2009 of 23 July 2009 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), Annex Part C, C.1 (published in the Official Journal of the European Union L 142 of 31 May 2008)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PG12122011 (dried from industrial lot 7476775)
- Expiration date of the lot/batch: 12 December 2013
- Purity test date: N/A

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: Not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Prior to treatment, a test solution of 100 mg/L was prepared by diluting an appropriate amount of test item in aquarium water
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: 100 mg/L
- Final preparation of a solid: N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material) As a liquid

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) N/A

OTHER SPECIFICS: N/A

Analytical monitoring:

yes

Remarks:

Analysis of test item concentration was performed by Seibersdorf Labor GmbH with the Test Site PI : Stefan Bauer. The samples were analysed by ICP/AES method.

Details on sampling:

- Sampling method: samples obtained from test facility
- Sample storage conditions before analysis: at room temperature

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: In aquarium water (circulated and filtered tap water). Prior to treatment, a test solution of 100 mg/L was prepared by diluting an appropriate amount of test item in aquarium water. As only limit test was carried out, further dilution of stock solution was not performed.
- Eluate: N/A
- Differential loading: N/A
- Controls: Circulated and filtered tap water without addition of test item
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): N/A
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): N/A
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Not specified
- Source: Ágnes Németh (self-employed), Veszprém, Hungary
- Age at study initiation (mean and range, SD): Not specifed
- Length at study initiation (length definition, mean, range and SD): Body length: 2.7 - 3.4 cm
- Weight at study initiation (mean and range, SD):
Measured weight of 7 fish (g): Control = 1.69; 100 mg/L nominal = 1.79
Calculated mean weight of 1 fish (g): Control = 0.24; 100 mg/L = 0.26
Loading of testing aquarium (g fish/L testing liquid): Control = 0.34; 100 mg/L nominal = 0.36
- Method of breeding: Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions.
- Maintenance of the brood fish: N/A

ACCLIMATION
- Acclimation period: >12 days
- Acclimation conditions (same as test or not): Not specified
- Type and amount of food during acclimation: Not specified
- Feeding frequency during acclimation: Not specified
- Health during acclimation (any mortality observed): Fish were observed during the acclimatisation as being healthy. There was no mortality of the population for seven days before the test.

QUARANTINE (wild caught) N/A

FEEDING DURING TEST
- Food type: None
- Amount: None
- Frequency: The fish were not fed during the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

The observations of fish were carried out in the following intervals: at 3, 6, 24, 48, 72 and 96 hours. Mortality and any sub-lethal effect were determined in each observation period.

Hardness:

54 mg/L (as CaCO3)

Test temperature:

22.6 - 23.5 °C

pH:

7.85 - 8.10

Dissolved oxygen:

75 - 98% of the air saturation value at the temperature used.

Salinity:

N/A

Conductivity:

N/A

Nominal and measured concentrations:

Preliminary range-finding test (nominal)
0.1, 1, 10 and 100 mg/L
Main test:
As significant toxic response was not observed during the preliminary range-finding test, only one test concentration (100 mg/L) and one control group were tested in a limit test in the definitive study.

Details on test conditions:

TEST SYSTEM
- Test vessel: One aquarium for test group and one for the control group
- Material, size, headspace, fill volume: Each aquaria was filled with 5 L test solution
- Aeration: N/A
- Type of flow-through (e.g. peristaltic or proportional diluter): N/A
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 4 fish per concentration for the preliminary test; 7 fish for the limit test(in the single concentration tested)
- No. of vessels per concentration (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: Less than 1.0 g fish/L test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Circulated and filtered tap water
- Total organic carbon: Not specified
- Particulate matter: Not specified
- Metals: Not specified
- Pesticides: Not specified
- Chlorine: Not specified
- Alkalinity: Not specified
- Ca/mg ratio: Not specified
- Culture medium different from test medium: N/A
- Intervals of water quality measurement: The water temperature, oxygen concentration and pH were measured at the start of the test and daily thereafter.

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: Not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The observations of fish were carried out at 3, 6, 24, 48, 72 and 96 hours. Mortality and any sub-lethal effect were determined in each observation period.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A (limit test performed with a single concentration)
- Justification for using less concentrations than requested by guideline: Significant toxic response was not observed during the preliminary range-finding test, therefore only one test concentration (100 mg/L) and one control group were tested in a limit test in the definitive study. This was in accordance with the OECD 203 Guideline.
- Range finding study: 0.1, 1, 10, 100 mg/L
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study:

Nominal concentrations [mg/L] Untreated control 0.1 1 10 100
Number of treated animals 4 4 4 4 4
Number of dead animals 0 0 0 0 0

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None reported
- Observations on body length and weight:
Body length of test fish at the end of the test:
Test Group Body Length [cm]
1 2 3 4 5 6 7
Control 3.0 3.1 2.8 2.9 3.2 2.9 3.0
100 mg/L (nominal) 3.1 3.3 3.3 3.0 3.4 2.8 2.7

- Other biological observations: No sub-lethal effects were observed in the control and test group for a period of 96 hours.
- Mortality of control: 0
- Other adverse effects control: N/A
- Abnormal responses: N/A
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: None

Results with reference substance (positive control):

N/A

Reported statistics and error estimates:

No statistical analysis was performed because of the lack of toxic effects.
The LC50, NOEC, LOEC and LC100 were determined directly from the raw data.

Sublethal observations / clinical signs:

Concentration of the test item in the test solutions was determined at the beginning and end of the test.

The corresponding test item concentration was 94.2 mg/L (based on the analytical measurements).

As the measured concentration deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations.

The 24h, 48h, 72h and 96h LC50 value was found to be  > 100 mg/L (nominal)

The 96h No-Observed Effect Concentration (NOEC):       100 mg/L (nominal)

The 96h Lowest Observed Effect Concentration (LOEC):       > 100 mg/L (nominal)

There were no mortalities in 7 fish in the control group or in 7 fish exposed to a test concentration of 100 mg/L (nominal).

Table 2. Cumulative mortality data in the definitive test

Test Group	Mortality rate of treated fish (Dead fish/Treated fish)
	3h	6h	24h	48h	72h	96h
Control	0/7	0/7	0/7	0/7	0/7	0/7
100 mg/L (nominal)	0/7	0/7	0/7	0/7	0/7	0/7

Table 3. Test temperature (°C)

Test Group	Measuring
	0h	24h	48h	72h	96h
Control	22.6	22.9	23.1	23.5	22.8
100 mg/L (nominal)	22.6	22.9	23.1	23.5	22.8

Table 4. Dissolved oxygen concentration (% of air saturation value)

Test Group	Measuring
	0h	24h	48h	72h	96h
Control	22.6	22.9	23.1	23.5	22.8
100 mg/L (nominal)	22.6	22.9	23.1	23.5	22.8

Table 5. pH

Test Group	Measuring
	0h	24h	48h	72h	96h
Control	7.85	7.92	7.95	8.08	8.10
100 mg/L (nominal)	7.88	7.90	7.93	7.95	8.00

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions in this test, the 96 h LC50 of the test item was found to be > 100 mg/L (nominal).

Executive summary:

An acute toxicity test to fish, compliant with OECD 203 was conducted on a mixture of sodium octane-1-sulfonate monohydrate and sodium hexane-1-sulfonate monohydrate (read-across source substance utilised for the target substance: sodium octane-1-sulphonate monohydrate) in order to establish the toxicity of the test item to Zebrafish (Brachydanio rerio) over a 96 hour period.

Based on a preliminary range-finding test, a limit test was carried out using only one test concentration (100 mg/L) and one control group in the definitive study.

Test concentrations were analytically determined at the start and at the end of the test. The corresponding measured geometric mean test item concentration was 94.2 mg/L (based on the analytical measurements). As the measured concentrations deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations.

One aquarium was used in test group and one in the control group, with both aquaria each containing seven fish and five litre test solution.

The number of mortalities and any sub-lethal effect were determined 3, 6, 24, 48, 72 and 96 hours after the start of exposure. There were no mortalities in the control nor the limit test. All validity criteria were met during this study.

Under the conditions in this test, the 96 h LC50 of the test item was found to be > 100 mg/L (nominal).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Read-across justification document is provided in Section 13.2.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions in the test conducted on the source substance (a mixture of sodium octane-1-sulfonate monohydrate and sodium hexane-1-sulfonate monohydrate), the 96 h LC50 of the test item was found to be > 100 mg/L (nominal). This result is appropriate under a read-across approach for applicability to the target substance sodium octane-1-sulphonate monohydrate.

Executive summary:

An acute toxicity test to fish, compliant with OECD 203 was conducted on a mixture of sodium octane-1-sulfonate monohydrate and sodium hexane-1-sulfonate monohydrate (read-across source substance utilised for the target substance: sodium octane-1-sulphonate monohydrate) in order to establish the toxicity of the test item to Zebrafish (Brachydanio rerio) over a 96 hour period.

Based on a preliminary range-finding test, a limit test was carried out using only one test concentration (100 mg/L) and one control group in the definitive study.

Test concentrations were analytically determined at the start and at the end of the test. The corresponding measured geometric mean test item concentration was 94.2 mg/L (based on the analytical measurements). As the measured concentrations deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations.

One aquarium was used in test group and one in the control group, with both aquaria each containing seven fish and five litre test solution.

The number of mortalities and any sub-lethal effect were determined 3, 6, 24, 48, 72 and 96 hours after the start of exposure. There were no mortalities in the control nor the limit test. All validity criteria were met during this study.

Under the conditions in this test, the 96 h LC50 of the test item was found to be > 100 mg/L (nominal).

Description of key information

Read-across performed: OECD 203; 96 h LC50 >100 mg/L (nominal), Sipos, K. (2018)

Additional information

An acute toxicity test to fish, compliant with OECD 203 was conducted on a mixture of sodium octane-1-sulfonate monohydrate and sodium hexane-1-sulfonate monohydrate (read-across source substance for target substance: sodium octane-1-sulphonate monohydrate) in order to establish the toxicity of the test item to Zebrafish (Brachydanio rerio) over a 96 hour period.

Based on a preliminary range-finding test, a limit test was carried out using only one test concentration (100 mg/L) and one control group in the definitive study.

Test concentrations were analytically determined at the start and at the end of the test. The corresponding measured geometric mean test item concentration was 94.2 mg/L (based on the analytical measurements). As the measured concentrations deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations.

One aquarium was used in test group and one in the control group, with both aquaria each containing seven fish and five litre test solution.

The number of mortalities and any sub-lethal effect were determined 3, 6, 24, 48, 72 and 96 hours after the start of exposure. There were no mortalities in the control nor the limit test. All validity criteria were met during this study.

Under the conditions in this test, the 96 h LC50 of the test item was found to be > 100 mg/L (nominal).