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Long-term toxicity to fish

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
no data
Salinity:
not relevant
Nominal and measured concentrations:
Nominal: 0, 26, 78, 233, 700 and 2100 µg/L
Measured: 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): 3

EFFECT 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.
Endpoint:
fish, juvenile growth test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
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: Source, key, 151-21-3, 1995
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: Source, key, 151-21-3, 1995

Description of key information

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

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
1.357 mg/L

Additional information

Since no reliable chronic toxicity test with fish is available for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to another structurally related substance was conducted. Read-across data from a 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 the C9, C10 and C11 homologues.

A 42-day flow-through study with fathead minnow (Pimephales promelas) examining the toxic effect of 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 was determined as 1.357 mg/L (measured concentration).

Due to structural and property similarities with the tested substance, it can be concluded that the above results apply also to Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt. The long-term NOEC values for fish is 1.357 mg/L.