Sulfonic acids, C6-8-alkane, sodium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 April - 03 May, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material (as cited in study report): Bio-Terge PAS 7S-DRY
- Analytical purity: 100 % (UVCB)
- Lot/batch No.: PG12122011 (dried from industrial lot 7476775)
- Expiration date of the lot/batch: 12 December 2013
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)

Analytical monitoring:

yes

Details on sampling:

Test concentrations were analytically determined at the start and at the end of the test.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

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.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Ágnes Németh (self-employed), Veszprém, Hungary
- Length at study initiation: 2.7 – 3.4 cm
- Method of breeding: Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions.
- Feeding during test: No

ACCLIMATION
- Acclimation period: >12 days
- Health during acclimation (any mortality observed): No mortality for seven days before the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

The hardness of the dilution water was determined as 54 mg/L (as CaCO3).

Test temperature:

The test temperature was between 22.6 and 23.5 °C.

pH:

The pH was in the range of 7.85 – 8.10.

Dissolved oxygen:

The dissolved oxygen concentration was in the range of 75 – 98 % of the air saturation value at the temperature used.

Salinity:

not applicable

Nominal and measured concentrations:

nominal: 100 mg/L
geometric mean test item concentration: 94.2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquarium
- Volume 5L
- Aeration: no data
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1.0 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: circulated and filtered tap water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The number of mortalities and any sub-lethal effect were determined 3, 6, 24, 48, 72 and 96 hours after the start of exposure.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable - limit test
- Range finding study
- Test concentrations: 0.1, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study:

Results of the Preliminary Range-Finding Test
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

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)

Details on results:

- Behavioural abnormalities: none
- Observations on body length and weight: no differences observed between test groups and controls
- Other biological observations:No sub-lethal effects were observed in the control and test group for a period of 96 hours
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- 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: no

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not applicable - limit test

Sublethal observations / clinical signs:

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.

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

Validity criteria fulfilled:

yes

Executive summary:

The acute toxicity of the test item to fish as assessed in a study performed according to OECD TG 203 over a period of 96 hours in a static test system using Danio rerio.

Based on the results of a preliminary study, the test was performed as a limit test using a test concentration of 100 mg/L and one control group. The test concentration was analytically determined at the start and end of the experiment. The geometric mean test item concentration was 94.2 mg/L. As the measured concentrations deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal test item concentration.

Seven fish were used in each of the test and control groups. There were no deaths observed in either group during the study. No sub-lethal effects were observed in either group and no differences in body length and weight were observed between the groups.

All validity criteria were met during the study.

Under the conditions of this study the 96-h toxicity to Danio rerio was > 100 mg/L.

Description of key information

Acute toxicity to fish: 96-h LC50 > 100 mg/L (Danio rerio; OECD TG 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

The acute toxicity of the test item to fish as assessed in a study performed according to OECD TG 203 over a period of 96 hours in a static test system using Danio rerio (Citoxlab, 2013).

Based on the results of a preliminary study, the test was performed as a limit test using a test concentration of 100 mg/L and one control group. The test concentration was analytically determined at the start and end of the experiment. The geometric mean test item concentration was 94.2 mg/L. As the measured concentrations deviated not more than 20 per cent from the nominal in all cases, biological results are based on the nominal test item concentration.

Seven fish were used in each of the test and control groups. There were no deaths observed in either group during the study. No sub-lethal effects were observed in either group and no differences in body length and weight were observed between the groups.

All validity criteria were met during the study.

Under the conditions of this study the 96-h toxicity to Danio rerio was > 100 mg/L.