Sulfuric acid, mono-C9-12-alkyl esters, sodium salts

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish, juvenile growth test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 Sept - 14 Oct 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Qualifier:

no guideline followed

Principles of method if other than guideline:

42 day exposure of fish in aquaria provided with continuous flow of river water (no cycle), stock solution addition.

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: Exposure concentrations were maintained by amending river water at the head of each stream with surfactant stocks in a dilution series, stocks were prepared in de-ionized carbon filtered water

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM- Common name: fathead minnow- Source: Virginia Tech, Department of Biology, Virginia - Age at study initiation (mean and range, SD): 4 weeks post hatch- Feeding during test: provided by stream water - Food type: natural organisms/detritus

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

42 d

Post exposure observation period:

not relevant

Test temperature:

Test begin: approx. 24 °CTest end: approx. 13 °C

Salinity:

not relevant

Nominal and measured concentrations:

Nominal: 0, 26, 78, 233, 700 and 2100 µg/LMeasured: 2 ± 5, 23 ± 30, 51 ± 17, 151 ± 44, 418 ± 103 and 1357 ± 408 µg/L

Details on test conditions:

TEST SYSTEM- Test vessel: Flow through aquaria drawing water from experimental stream channels - Type (delete if not applicable): open - Material, size, headspace, fill volume: 75 L- Type of flow-through (e.g. peristaltic or proportional diluter): peristaltic pump- Renewal rate of test solution (frequency/flow rate): 400 mL/min (hydraulic residence time was 160 minutes)- No. of organisms per vessel: 10 - No. of vessels per concentration (replicates): 3- No. of vessels per control (replicates): 3EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : juvenile mortality and juvenile growth

Reference substance (positive control):

no

Duration:

42 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.357 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

weight

Remarks on result:

other: ± 0.408 mg/L

Duration:

42 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.357 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: ± 0.408 mg/L

Reported statistics and error estimates:

Parametric and non-parametric analysis of variance (Kruskal-Wallis), using SAS (Statistical Analysis System 1990). Multiple range tests used were at Least Significant Differences Procedure and Wilcoxon Rank Sum. NOEC are defined as the highest exposure concentration which did not significantly impair the tested population relative to the control.

Reference 2

Endpoint:

fish, juvenile growth test

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Reason / purpose for cross-reference:

read-across source

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: Exposure concentrations were maintained by amending river water at the head of each stream with surfactant stocks in a dilution series, stocks were prepared in de-ionized carbon filtered water

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM- Common name: fathead minnow- Source: Virginia Tech, Department of Biology, Virginia - Age at study initiation (mean and range, SD): 4 weeks post hatch- Feeding during test: provided by stream water - Food type: natural organisms/detritus

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

42 d

Post exposure observation period:

not relevant

Test temperature:

no data

Salinity:

not relevant

Nominal and measured concentrations:

Nominal: 0, 26, 78, 233, 700 and 2100 µg/LMeasured: 2 ± 5, 23 ± 30, 51 ± 17, 151 ± 44, 418 ± 103 and 1357 ± 408 µg/L

Details on test conditions:

TEST SYSTEM- Test vessel: Flow through aquaria drawing water from experimental stream channels - Type (delete if not applicable): open - Material, size, headspace, fill volume: 75 L- Type of flow-through (e.g. peristaltic or proportional diluter): peristaltic pump- Renewal rate of test solution (frequency/flow rate): 400 mL/min (hydraulic residence time was 160 minutes)- No. of organisms per vessel: 10 - No. of vessels per concentration (replicates): 3- No. of vessels per control (replicates): 3EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : juvenile mortality and juvenile growth

Reference substance (positive control):

no

Duration:

42 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.357 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

weight

Remarks on result:

other: ± 0.408 mg/L

Duration:

42 d

Dose descriptor:

NOEC

Effect conc.:

>= 1.357 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: ± 0.408 mg/L

Reported statistics and error estimates:

Parametric and non-parametric analysis of variance (Kruskal-Wallis), using SAS (Statistical Analysis System 1990). Multiple range tests used were at Least Significant Differences Procedure and Wilcoxon Rank Sum. NOEC are defined as the highest exposure concentration which did not significantly impair the tested population relative to the control.

Description of key information

42d NOEC (Pimephales promelas; mortality and growth) >= 1.357 mg/L (measured concentration)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1.357 mg/L

Additional information

Since no reliable chronic fish test is available for C9-12AS Na, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read-across to another structurally related category member was conducted. Read-across data from the C12 homologue - C12AS Na (CAS 151-21-3) were used. As the toxicity of alkyl sulfates is dependent on the carbon chain length, it is expected that the C12 homologue will be the worst case scenario for C9-12AS Na.

A 42-day flow-through study with fathead minnow (Pimephales promelas) examining the toxic effect of C12AS Na (CAS 151-21-3) is available (Belanger et al. 1995). Juvenile mortality and juvenile growth were determined in a non-GLP test after exposure to five concentrations up to 1.357 mg/L (measured concentration, equal to 2.1 mg/L of nominal concentration). Since no adverse effects were observed regarding fish survival and body weight, the NOEC value was determined as equal as or higher than 1.357 mg/L (measured concentration).

Due to structural and property similarities with the tested category member, it can be concluded that the above result applies also to C9-12AS Na.