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Long-term toxicity to fish

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Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-07-11 to 1986-08-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all replicate test solutions and the control on day 0, 3, 11 and weekly thereafter until test termination.
- Sampling method: Each test solution sample was collected from the approximate midpoint of the aquarium with a volumetric pipet. Two Quality Assurance (QA) blind samples were prepared at each sampling interval and remained with the set of samples through extraction and analysis. These samples were prepared in dilution water at a test material concentration unknown to the analyst. Analyses of the QA samples were used to determine the precision and quality control maintained during the analytical procedures.
- Sample storage conditions before analysis: N/A
- Note: 3 days before the exposure period began, the control, high, middle and low test concentrations (A and B replicates) were sampled and analyzed for the test material. Results of these analyses were used to judge whether sufficient quantities of test material were being delivered and maintained in the exposure aquaria to initiate the test.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Diluter stock solutions were prepared daily by adding 3.39 g of the test substance to 2800 mL of deionized water. The resulting stock solution contained 0.89 mg/mL of the test substance as active ingredient. A modified proportional diluter with a 0.50 dilution factor was used to prepare and deliver the selected test concentration range of the test substance to the aquaria during the 34-day exposure. The dilution and control water was well water.
- Controls: well water
- Evidence of undissolved material: N/A
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead Minnow
- Source: Springborn Bionomics Culture Facility, Wareham, Massachusetts


METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish: N/A
- Method of collection of fertilized eggs: Embryos obtained within 24 hours after fertilization from the fathead minnow culture unit maintained at Springborn Bionomics, Inc., Wareham, Massachusetts. Sixty embryos were impartially distributed to each of 14 embryo incubation cups, one of which was then suspended in each duplicate test aquarium per exposure concentration and the control.
- Subsequent handling of eggs: Embryo incubation cups were glass jars (5 cm O.D., 8 cm high) with 16-mesh Nitex screen bottoms. A rocker arm apparatus was used to gently oscillate the incubation cups in the test solutions. Dead embryos were counted daily until hatching was complete.


POST-HATCH FEEDING
- Start date: Hatching was deemed completed (exposure day 4) when no more than 5 unhatched viable remained in any embryo incubation cup.
- Type/source of feed: Larvae were fed live brine shrimp (Artemia salina) nauplii
- Amount given: N/A
- Frequency of feeding: three times daily on weekdays and twice daily on weekends and holidays.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
34 d
Post exposure observation period:
N/A
Hardness:
Mean = 26.0 SD =1.0 n = 3 Range: 25-27 (CaCO3)
Test temperature:
Mean = 26.1 SD = 0.38 n=7 Range 26-27
pH:
6.8 - 7.7
Dissolved oxygen:
Mean = 7.2 SD =0.29 n=7 Range 6.9 - 7.6.
Salinity:
N/A
Nominal and measured concentrations:
Nominal test concentrations were: 0 (control), 0.19, 0.38, 0.75, 1.5, 3.0, and 6.0 mg/L (active ingredient).
Mean measured concentrations were: <0.017 (control), 0.027, 0.076, 0.11, 0.35, 1.1, and 4.3 mg/L. Mean measured concentrations were 14-72% of nominal. Results are based on measured concentration. More details on measured concentrations are in "any other information on materials and methods" below.
Details on test conditions:
TEST SYSTEM
- Embryo cups: Embryo incubation cups were glass jars (5 cm O.D., 8 cm high) with 16-mesh Nitex screen bottoms
- Test vessel: Aquarium
- Type: open
- Material: Each glass test aquarium measured 39 X 20 X 25 cm with a 19.5 cm high side drain that maintained a constant test water volume of 15 L.
- Aeration: No (test was flow-through)
- Type of flow-through: a modified proportional diluter with a 0.50 dilution factor.
- Renewal rate of test solution: The diluter delivered 0.5 L of test water to each aquarium at an average rate of 169 times per day. This is equivalent to approximately 5.6 aquarium volume replacements per 24-hour period.
- No. of fertilized eggs/embryos per vessel: 60
- Larvae: 40 live larvae were selected from each incubation cup on test day 4 and placed into their respective aquaria.
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water was well water which was pumped into an epoxy-coated concrete reservoir where it was supplemented with Town of Wareham untreated well water and aerated.
- Culture medium different from test medium: No
- Intervals of water quality measurement: pH, DO, and temperature were measured daily in one replicate of each test concentration and control. Replicates were alternated daily such that each aquarium was monitored every other day.

OTHER TEST CONDITIONS
- Adjustment of pH: N/A
- Photoperiod: 16 hours of light
- Light intensity: 20-100 foot-candles at the water surface were provided each day. Illumination was provided by Cool White and Grow Lux fluorescent lights centrally located above the test aquaria.

EFFECT PARAMETERS MEASURED: mortality and growth

RANGE-FINDING STUDY: no

POST-HATCH DETAILS
- Begin of post-hatch period: test day 4
- No. of hatched eggs (alevins)/treatment released to the test chamber: 40
- Release of alevins from incubation cups to test chamber on day no.: test day 4

FERTILIZATION SUCCESS STUDY
- Number of eggs used: 60 embryos
- Removal of eggs to check the embryonic development on day no.: N/A
Reference substance (positive control):
no
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.11 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: larvae survival
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
length
Remarks on result:
other: larvae growth
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
weight
Remarks on result:
other: larvae growth
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: survival of embryos at hatch
Duration:
34 d
Dose descriptor:
LOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: larvae survival
Details on results:
- Mortality/survival at embryo, larval, juvenile, and adult stages: see table below in remarks on results including tables and figures.
- Days to hatch: 4
- Observations on body length and weight of young and/or exposed parents at one or more time periods: see table below in remarks on results including tables and figures.
- Other biological observations: No hatch at highest test concentration.
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
At the termination of the study, the data obtained on embryo survival at hatch, larval growth (wet weigh and total length) and larval survival were statistically analyzed according to the following procedure:

Significant differences in the percentage survival were determined after angular (arcsine square-root percentage) transformation of the data. Statistical comparison between results of control and various dose levels of the test substance was based on Dunnet's test. All measured (length and weights) or calculated (survival) data points were entered individually in the statistical analyses to enhance the power of the test. Differences in the number of individual values (e.g., due to mortalities) between control and treatment levels were incorporated in the test.

 

 

Mean Measured Concentration (mg/L)

 

 

Survival of Embryos at Hatch (%)

 

Larvae

 

Survival of Larvae (%)

Mean Total Length (mm)

Mean Wet Weight (mg)

<= 0.017

94 (1)^2

100(0)^2

34(2)^3

373 (62)

0.027

90(4)

93(7)^4

34(2)

388(83)

0.076

94(2)

99(1)

34(3)

387(90)

0.11

93(0)

97(2)^4

34(2)

388(84)

0.35

97(2)

85(7)*

34(2)

388(68)

1.1

62(16)*

8.3(2)*

27(6)*

224(92)*

4.3

0*

- - -

- - -

- - -

1 Only live hatching embryos exposed during larval stage.

2 Mean (S.D.) of 2 replicate chambers.

3 Mean (S.D.) of all life fish exposed at the concentration.

4 Significantly different from control but not biologically meaningful.

* Significantly different from control.

Validity criteria fulfilled:
yes
Conclusions:
The chronic toxicity of C45AS (C14/15-alkyl sulfate) to fish was evaluated in a 34 day FELS test with fathead minnows, according to the OECD 210 guideline. The NOEC was 0.11 mg/L, based on larvae survival (mean measured concentration). The NOEC was 0.35 mg/L, based on survival of embryos at hatch, and growth of larvae (weight, length).
Executive summary:

The chronic toxicity of C45AS (C14/15 -alkyl sulfate) to fish was evaluated in a 34 day FELS (fish early life stage) test with fathead minnows, following the OECD 210 guideline. Nominal test concentrations were 0, 0.19, 0.38, 0.75, 1.5, 3.0, and 6.0 mg/L (active ingredient basis). Mean measured concentrations were 14 -72% of nominal, and results are based on mean measured concentrations.

Fathead minnow (Pimephales promelas) embryos and larvae were continuously exposed to the test substance for 34 days in a flow-through system. Observations were made on survival of embryos at hatch, and the survival and growth of larvae during 30 days post-hatch exposure.

Larvae survival was the most sensitive indicator of the effect of C45AS. The 34 day NOEC, based on larvae survival, was 0.11 mg/L (measured concentration, active ingredient).

The 34 day NOEC, based on embryo hatching and larvae growth, was 0.35 mg/L.

This test met the validity criteria of the OECD 210 guideline.

Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997-07-21 to 1997-08-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD Series on Testing and Assessment, Number 53: Guidance Document on Simulated Freshwater Lentic Field Tests (Outdoor Microcosms and Mesocosms), ENV/JM/MONO(2006)17, Organization for Economic Cooperation and Development, Paris France.
Deviations:
no
Principles of method if other than guideline:
OECD 53 was adapted by P&G to reflect the unique attributes of the Experimental Stream Facility (ESF), an indoor experimental stream mesocosm consisting of 8, 12 meter long indoor stream channels that drew unfiltered water from the Lower East Fork of the Little Miami River (LEFR). The Facility was designed to evaluate long-term (56-day) effects of test substances to high quality, lotic (flowing) freshwater biota. The ESF enabled population and community level effects testing equivalent to the realism of a field study (see Details on Test System, below; see Giddings et al., 2002 in attached references).

This 35 day study is a sub-set of the overall mesocosm study.
GLP compliance:
yes
Remarks:
The mesocosm study was conducted according to OECD Test Guideline 53, following robust standard operating procedures (SOPs), and with extensive documentation, similar or equivalent to Good Laboratory Practice standards.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: All concentrations. Frequency not detailed in the study report.
- Sampling method: 1-L grab samples from the tail pool in each experimental stream.
- Sample storage conditions before analysis: Preserved in 3% formalin (v/v) at room temperature.
See Table 1 below for sampling numbers, means and standard deviations.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions of C14-15AS were prepared every 4 days by diluting an initially prepared super stock solution. This was done to achieve a stable dispersion of C14-15AS. C14-15AS neat chemical was heated to 49 ± 28 °C in a constant-temperature room. An appropriate aliquot (~4.4 kg) of heated chemical was diluted immediately in high-quality water (17 megaohm) at 66 ± 28 °C. The solution was mixed for 5 minutes and brought to a volume of 6.0 L in a large glass beaker on a stir plate held at 82 ± 28 °C. The super stock solution was diluted in 45.8 L of high-quality water at an equivalent temperature and mixed for an additional 2 hours. The mixture was then cooled for 24 hours and appropriate amounts were transferred to individual ESF test chemical feed tanks. Two 456-L stainless steel tanks were dedicated for delivering stock solutions to each stream channel. These tanks were used in a reciprocating manner with stocks being renewed every 4 days throughout the study.
- Controls: River water pumped continuously from the Lower East Fork of the LIttle Miami River (no test substance added).
- Evidence of undissolved material: None
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Strain: N/A
- Source: Aquatic Research Organisms, Hampton, NH
- Age at study initiation: 4-6 months
- Weight at study initiation (mean and SD): 0.17 g (0.079)
- Method of breeding: during culture, fish were fed Tetramin, brine shrimp, and/or other fish food.
- Length at study initiation (mean and SD): 26.5 mm (2.9)
- Feeding during test: yes
- Food type: Natural, provided from natural river inflow and colonization on cobbles.
- Amount: Variable, depending on what was available from the river, what colonized the cobbles, and on invertebrates, community interactions (intra- and inter-specific competition, predation, trophic feeding level, timing of emergence, etc.).
- Frequency: Ad libitum, according to what was available in the stream mesocosm.

ACCLIMATION
- Acclimation period: A minimum of 5 days
- Acclimation conditions: Same as test

THIS ENDPOINT IS ONLY CONCERNED WITH A 35 DAY DOSING PERIOD WITHIN THE MESOCOSM STUDY

All exposures occurred at the Procter & Gamble Experimental Stream Facility (ESF) in Milford, Ohio (Belanger, 1997). This facility houses a series of 10-meter long streams. The streams consist of a head tank, a gentle sloping (2 degree) periphyton region, which is 40 cm across and 4 meters long, a macroinvertebrate region (4 degree slope, 60 cm x 4 meters) and a tail pool. The periphyton region contains cobble packed into trays for sampling of invertebrate communities. River water (Lower East Fork of the Little Miami River, Milford, OH) is used to colonize and conduct tests. Test chemical is metered into river water and allowed to flow through the streams on a continuous flow, once through basis. Single species are housed in cages where they receive exposure to the river water and test chemical. These cages are placed in the tailpool of the experimental stream.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
35 d
Post exposure observation period:
None
Hardness:
Avg (SD) = 159 (16) mg/L as CaCO3
Test temperature:
Avg (SD) = 24 (1.9) degrees Celsius
pH:
Range = 7.5 - 8.3 S.U.
Dissolved oxygen:
Avg (SD) = 7.6 (0.4) mg/L
Salinity:
N/A
Nominal and measured concentrations:
Nominal- Control (0), 62.5, 125, 250, and 500 ug/L (as active ingredient)
Measured- Control (0.5), 50, 89, 186, and 371 ug/L C14-15AS (mean tailpool cage values, as active ingredient). See Table 1. Mean measured concentrations were 71-80% of nominal.
Details on test conditions:
TEST SYSTEM
- Test vessel: Single species exposures occurred in cages placed in the tail pool of the experimental streams. The Experimental Stream Facility, an indoor experimental stream mesocosm, housed eight 12-meter long stream channels that continuously drew unfiltered water from the LEFR (see river description above under Colonization). The intake pump in the river was screw-driven rather than impeller-driven to avoid injuring aquatic organisms in transit to the ESF. Coarse 1x2 cm screens at the intake were used to remove large debris. The ESF was approximately 75 meters from the river.

The stream channels were designed to mimic a riffle community dominated by a variety of organisms including sensitive species of mayflies, stoneflies, and caddisflies. Mean stream flow was 50 cm per second, achieved by varying channel slopes (1% for periphyton sections and 4.5% slope for invertebrate sections).

- Material: Stream channels were constructed of UV-resistant, polypropylene laminated fibre-glass, with sidewalls and were open similar to a stream channel in the field. They contained five distinct sampling regions:
(1) A 126-L upstream headbox (mixing chamber).
(2) An upstream periphyton reach 4.3 meters long and 0.3 meters wide, lined with unglazed terra cotta tiles (8800 mm2) colonized by periphyton, in 3 columns x 45 rows.
(3) A tapered region (transition zone) leading from the narrower upstream reach to a wider downstream reach.
(4) A downstream reach 4.3 meters long and 0.5 meters wide, containing 3 columns x 15 rows of cobble-filled polypropylene trays colonized by invertebrates. Cobbles averaged 2-cm in diameter in trays of 0.0043 m2 size (dimensions of 26 cm long, 15.9 cm wide, 6.4 cm deep). Cobbles were collected from the river. At intersecting corners of trays, a 25-cm2 square tile directed water flow through the trays. Water depth varied from 2.0-3.0 cm through the invertebrate reach.
(5) A 222-L tail pool was located at the base of the streams, to allow caged fish and invertebrate exposures.

- Aeration: Provided naturally by flowing streamwater

- Type of flow-through: A flow controller was attached to each head tank to provide constant, non-impinged flow at the desired level.

- Renewal rate of test solution: Stream flow in each channel was 167 L per minute, at 50 cm per second average velocity.
- No. of organisms per vessel: 20 organisms per species placed in cages suspended in tail pool of each stream.
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: N/A

TEST MEDIUM / WATER PARAMETERS
Information on water quality was gathered by a variety of techniques. The ESF computerized data acquisition system was used to collect and analyze D.O., pH, specific conductance, and temperature information on a 5 minute basis.

Comprehensive water quality assessments were performed on a weekly to biweekly basis over the 112-day period from grab samples collected from the tail pool of the control stream. Solid state or membrane probes in the tail pools that measured temperature, pH, conductivity, and D.O. continuously were calibrated every four days.

Table 2, below, provides means and averages for monitored parameters including major cations, anions, nutrients, and organic carbon. Confirmation of low or no levels of pollutants in ESF source water and sediment was accomplished by a scan for the 137 priority and conventional pollutants listed by USEPA (Keith, 1991) prior to colonization. Grab water and sediment samples were collected at the ESF intake on the LEFR above and below the adjacent wastewater facility operated by Clermont County, Ohio. Priority pollutant scans consist of general water quality parameters, volatile compounds, pesticides, PCBs and other semi-volatile compounds, and metals/metalloids.

- Source/preparation of dilution water: Natural, unfiltered river water (see Colonization above).

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: A natural photoperiod was achieved in the ESF, assisted by a Paragon Suntracker computer algorithm each day. Gradual dawn and dusk changes in light intensity were mimicked to simulate the natural cycle of the geographic location (39°8’7” N, 85°15’13” W) throughout the colonization and exposure periods.
- Light intensity: 95 uM/s/m2 at the water surface at mid-day conditions were provided by 30, daylight-equivalent, 1000-W halide arc lamps. Their light spectrum ranged from infrared to ultraviolet. Light intensity was similar to the areas of the adjacent Little Miami River shaded by riparian vegetation.
- Dosing period: 1997-07-22 to 1997-09-15

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0 (nominal test concentrations); 1.8-2.1 (measured test concentrations)
- Justification for using fewer concentrations than requested by guideline: N/A
- Range finding study: No. Choice of test concentrations were based on a broad ecotoxicity database for anionic surfactants and expert judgment.
Reference substance (positive control):
no
Duration:
35 d
Dose descriptor:
other: EC20
Effect conc.:
150 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
280 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
length
Duration:
35 d
Dose descriptor:
other: EC20
Effect conc.:
> 371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
length
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
> 371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
length
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
weight
Duration:
35 d
Dose descriptor:
other: EC20
Effect conc.:
> 371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
weight
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
> 371 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
weight
Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
Probit was used to determine EC20, EC50 values for survival endpoints. NOECs were estimated using ANOVA followed by Dunnett's multiple comparison test. All statistical analyses were conducted with the SAS system for WindowsTM (version 6.12, SAS Institute Inc., Cary, NC, USA). Statistical significance was inferred at p < 0.05.

35 Day Chronic Exposure Results: C14 -C15 to Pimphales promelas

Survival:

The 35 day EC20 is 150 ug/L;

The 35 day EC50 is 280 ug/L;

Length:

The NOEC is 371 ug/L;

The LOEC is >371 ug/L;

The EC20 is >371 ug/L;

The EC50 is >371 ug/L:

Weight:

The NOEC is 371 ug/L;

The LOEC is >371 ug/L;

The EC20 is >371 ug/L;

The EC50 is >371 ug/L

See Attached Figure 2

Validity criteria fulfilled:
yes
Conclusions:
The 35 day EC20 of C45AS (C14/15-alkyl sulfate) to Fathead minnow was 150 ug/L, based on survival (measured concentration). The 35 day NOEC was 371 ug/L, based on length and weight.
Executive summary:

This 35 day chronic fish study of C45AS (C14/15 -alkyl sulfate) was conducted in conjuction with the mesocosm study performed at the Environmental Stream Facility (ESF) in Milford, Ohio. Nominal test concentrations were Control (0), 62.5, 125, 250, and 500 micrograms/L. Mean measured test concentrations in the tailpools where the fish were caged were Control (0), 50, 89, 186, and 371 ug/L. Mean measured concentrations were 71 -80% of nominal, and results are based on measured concentrations.

The 35 day EC20 of C45AS to Fathead minnows was 150 ug/L, based on survival (measured concentrations). The 35 day NOEC was 371 ug/L, based on length and weight.

These P.promelas results should be interpreted in conjunction with results for invertebrates, periphyton, and other endpoints from the mesocosm study, as changes in these communities may have affected the response of Fathead minnows (e.g., due to competition from other invertebrate species, availability of periphyton as a food source, etc. See Belanger, 1997).

Endpoint:
adult fish: sub(lethal) effects
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
ummary 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 for cross-reference:
read-across source
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.11 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: larvae survival
Remarks:
Source, key, 68081-98-1, 1987
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
length
Remarks on result:
other: larvae growth
Remarks:
Source, key, 68081-98-1, 1987
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
weight
Remarks on result:
other: larvae growth
Remarks:
Source, key, 68081-98-1, 1987
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: survival of embryos at hatch
Remarks:
Source, key, 68081-98-1, 1987
Duration:
34 d
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: larvae survival
Remarks:
Source, key, 68081-98-1, 1987

Description of key information

34d NOEC (Pimephales promelas; larvae survival) = 0.11 mg/L (measured concentration)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.11 mg/L

Additional information

Since no reliable chronic fish test is available for C14-16AS Na (CAS 91648-54-3), a read-across to other structurally related category members was conducted in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5. Read-across data from C14-15AS Na were used. Toxicity of alkyl sulfates is dependent on the carbon chain length and the influence of the counter ion can be neglected.

In two studies fathead minnows (Pimephales promelas) were exposed to C14 -15AS Na which is considered to be the worst case mixture for the whole alkyl sulfate category. In the non-GLP study of P&G (1987), which was conducted according to a protocol equivalent to OECD Guideline 210, fathead minnow was exposed to C14-15AS over 34 days in a flow-through system. The highest test concentration was 6.0 mg a.i./L (nominal concentration) equal to 4.3 mg a.i./L (measured concentration). The early-life stage test resulted in the lowest NOEC-value of 0.11 mg a.i./L (measured concentration) for larvae survival.

This result corresponds well with the NOEC-value determined in a GLP-study of P&G (1997). In this test fathead minnows (Pimephales promelas) were exposed with the same C14-15AS Na mixture (56% C14 and 44% C15) in an outdoor flow-through system over 35 days. The exposure method is described as equivalent to OECD 53, guidance on simulated freshwater lentic field tests. The resulting NOEC-value is reported to be 0.371 mg/L for growth (length and weight).

Due to structural and property similarities with the tested category members it can be concluded that the above results apply also to C14 -16AS Na (CAS 91648-54-3). It can be concluded that the reliable NOEC value for fish is 0.11 mg/L.