Alcohols, C16-18

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Deviations:

yes

Remarks:

(appropriate and proportionate modifications to address the extreme technical difficulty of carrying out the test with such a rapidly biodegradable substance).

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Target: Negative control, 0.13, 0.26, 0.53, 1.1 and 2.1 mg/l.

- Sampling method: water samples were collected from one vessel from each exposure and control treatment, 2 and 6 days prior to test initiation to confirm the operation of the diluter. stock solutions were also collected 2 days prior to test initiation to confirm the test stock concentration. Water samples and test stock solution were collected on Days 0, 1, 5, 8, 12, 14, 20, 22, 27, 29 and 33 (test termination) to determine concentrations of the test substance in the test chambers. Water samples were collected from alternating replicate test chambers of each treatment and control group, while the stock sample was collected directly from the stock chamber. All samples were collected at mid-depth in the test chambers or stock chamber.

- Sample storage conditions before analysis: samples were placed in Teflon® centrifuge tubes containing hexane (volume of hexane was 20.0 mL for the negative control and 0.13 mg/L; 10.0 mL for the 0.26 and 0.53 mg/L and 5.0 mL for the 1.1 and 2.1 mg/L treatment level, respectively) and processed immediately for analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution was prepared continuously during the test by delivering the test material directly into the stainless steel stock solution chamber using a syringe pump and mixed with the dilution water. During the pretest diluter verification, the test stock solution at 20 mg/l was prepared by injecting test substance at a flow rate of 2.51 µl/min and mix with the dilution water that was delivered into the stock solution chamber at a rate of 104 ml/min. Based on the measured concentrations of the pretest diluter verification samples on Day-5, the test stock concentration was increased from 20 mg/l to 36 mg/l by injecting test substance into the test stock chamber at a rate of 4.52 µl/min and mix with the dilution water that was delivered into the stock solution chamber at a rate of 104 ml/min. The test stock solution in the stock chamber and the test solutions in the mixing chambers were stirred continuously and were protected from light. The negative control received dilution water only.

The toxicity test was conducted using an exposure system consisting of a continuous-flow diluter used to deliver each concentration of the test substance and a negative control (dilution water) to test vessels. A syringe pump (Harvard Apparatus, Holliston, Massachusetts) was used to deliver the test substance into a stainless steel stock solution chamber and mixed with dilution water to prepare the 20 mg/l test stock solution. Fluid metering pumps (Fluid Metering, Inc., Syosset, New York) were used to deliver volumes of a single test stock solution to the mixing chambers indiscriminately assigned to each target treatment concentration. The stock solution was diluted with well water in the mixing chambers to obtain the desired target test concentrations prior to delivery to the test chambers. After mixing, the flow of test water from each mixing chamber was split and allowed to flow into four replicate test chambers.

The fluid metering pumps used to deliver the stock solution to the mixing chambers and the rotameters used to control the flow of dilution water to the mixing chambers were calibrated prior to the test and calibrated/verified approximately twice weekly during the test to ensure that flow rates varied by no more than ± 5% of the target flow rate for each treatment. The proportion of the test water that was split into each replicate was checked prior to the test and approximately twice each week during the test to ensure that flow rates varied by no more than ±10% of the mean for the four replicates. The general operation of the diluter was checked visually at least two times per day during the test and at least once at the end of the test. Periodically during the test, all organisms were transferred to clean test chambers to prevent the buildup of bacterial/fungal growth.

The delivery system and the test chambers were placed in a temperature-controlled environmental chamber to maintain the target water temperature throughout the test period. Test chambers were 9-L glass aquaria filled with approximately 7 L of test water. The volume in the test chambers was maintained by an overflow port on the side of the test chamber. The depth of the test water in a representative test chamber was 15.6 cm. All test chambers were labeled with the project number, test concentration and replicate designation.

See Table 1 in "any other information on materials and methods incl. tables".

- Controls: dilution water only

- Evidence of undissolved material (e.g. precipitate, surface film, etc): none reported

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Strain: Pimephales promelas
- Source: Chesapeake Cultures, Inc. Hayes, Virginia 23072, USA
- Age of test organisms: Embryos (<24 hours old)

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs): Embryos collected for use in the test were from ten individual spawns.
- Method of collection of fertilised eggs: Embryos were removed from the spawning substrates and examined under a dissecting microscope to select healthy, viable specimens at approximately the same stage of development.
- Subsequent handling of eggs: Groups of 1 to 3 embryos were impartially distributed among incubation cups until each cup contained 20 embryos. One cup was placed in each treatment and control test chamber.

POST-HATCH FEEDING
- Start date: Newly hatched
- Type/source of feed: Live brine shrimp nauplii (Artemia sp.), obtained by hatching cysts purchased from Brine Shrimp Direct, Ogden, Utah.
- Amount given: not reported.
- Frequency of feeding: 3 times per day during the first seven days of post-hatch. Thereafter, they were fed three times per day on weekdays and at least two times per day on weekends. Fish were not fed for approximately 55 hours prior to the termination of the test to allow for clearance of the digestive tracts before weight measurements were made. To ensure that the feeding rate per fish remained constant, rations were adjusted at least weekly to account for losses due to mortality.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

33 d

Remarks on exposure duration:

(28 d post-hatch)

Hardness:

135 ± 6 mg/l as CaCO3 (control); 141 ± 6 mg/l as CaCO3 (2.4 mg/l test concentration)

Test temperature:

24.7°C to 26.0°C based on continuous measurements throughout the test.

pH:

7.9 - 8.1

Dissolved oxygen:

7.4 - 8.2 (A dissolved oxygen concentration of 4.9 mg/L represents 60% saturation at 25ºC in freshwater.)

Salinity:

not applicable

Nominal and measured concentrations:

Nominal concentrations: 0, 0.13, 0.26, 0.53, 1.1, 2.1 mg/l

Details on test conditions:

TEST SYSTEM
- Emybro cups (if used, type/material, size, fill volume): Embryos were held in incubation cups constructed from glass cylinders approximately 50 mm in diameter with 425 µm nylon screen mesh attached to the bottom with silicone sealant.
- Test vessel: glass aquaria.
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 9-L glass aquaria filled with approximately 7 L of test water. The volume in the test chambers was maintained by an overflow port on the side of the test chamber. The depth of the test water in a representative test chamber was 15.6 cm.
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): proportional
- Renewal rate of test solution (frequency/flow rate): The diluter flow rate was adjusted to provide approximately 20 volume additions of test water in each test chamber per day.
- No. of fertilized eggs/embryos per vessel: 20 embryos per incubation cup. 1 cup for each treatment concentration and control. 80 empbryos per treatment.
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): n/a
- Biomass loading rate: at the end of the test, based on the mean wet weight of the negative control group, was 0.015 g of fish per liter of test solution that passed through the test chamber during a 24-hour period. Instantaneous loading (the total wet weight of fish per liter of water in the tank) at the end of the test was 0.30 g fish/L.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: freshwater obtained from a well approximately 40 meters deep located on the Wildlife International site. The well water was passed through a sand filter to remove particles greater than approximately 25 µm, and pumped into a 37,800 l storage tank where the water was aerated with spray nozzles. Prior to use, the water was filtered to 0.45 µm to remove fine particles and was passed through an ultraviolet (UV) sterilizer.
- Total organic carbon: <1 mg C/l
- Particulate matter: water was filtered to 0.45 µm to remove fine particles
- Alkalinity: 177 (control) and 178 mg/l (exposure vessel) as CaCO3
- Conductivity: 332 (control) and 327 (exposure vessel) µS/cm
- Culture medium different from test medium: not reported
- Intervals of water quality measurement: at the beginning of the test, weekly during the test, and at the end of the test

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16h light, 8 h darkness with a 30 min transition period.
- Light intensity: Fluorescent light bulbs that emit wavelengths similar to natural sunlight

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Daily observations from Day 0 (hatching) of lethal and sublethal effects.


RANGE-FINDING STUDY
Results of the range finding study are not available

POST-HATCH DETAILS
- Begin of post-hatch period: when hatching reached >90% in the control groups
- No. of hatched eggs (alevins)/treatment released to the test chamber: 96% hatching sucess in the controls
- Release of alevins from incubation cups to test chamber on day no.: 5

FERTILIZATION SUCCESS STUDY
not reported

Reference substance (positive control):

no

Key result

Duration:

33 d

Dose descriptor:

EC10

Effect conc.:

0.43 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: (95% CL 0.29-0.90 mg/l)

Key result

Duration:

33 d

Dose descriptor:

NOEC

Effect conc.:

0.26 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: growth based on total length (most sensitive endpoint)

Duration:

33 d

Dose descriptor:

EC10

Effect conc.:

1.25 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: fish weight (dry weight)

Remarks on result:

other: (95% CL 1.13 - 1.37 mg/l)

Duration:

33 d

Dose descriptor:

EC10

Effect conc.:

1.2 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: fish weight (wet weight)

Remarks on result:

other: (95% CL 1.11-1.29 mg/l)

Duration:

33 d

Effect conc.:

1.27 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: fish length

Remarks on result:

other: (95% CL 1.14 - 1.41 mg/l)

Duration:

33 d

Dose descriptor:

EC10

Effect conc.:

> 2.4 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

number hatched

Duration:

33 d

Dose descriptor:

LOEC

Effect conc.:

0.54 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: growth based on total length (most sensitive endpoint)

Details on results:

In general, the majority of the fish in the control groups and in the 0.13 and 0.26 mg/L treatment groups appeared normal throughout the test. There were organisms that were noted with sublethal observations including weak, appeared smaller in comparison to the fish in the control replicates, curled or crooked spine, pale, loss of buoyancy (unable to maintain position in the water’s column), hemorrhage and/or loss part of caudal fin. Although these observations appeared to be dose-responsive they were also noted in the control organisms.

- Mortality/survival at embryo, larval, juvenile, and adult stages: Larval survival in the negative control group was 87%. Larval survival in the negative control, 0.13, 0.26, 0.54, 1.2 and 2.4 mg/L treatment groups was 91, 92, 76, 56 and 2.5%, respectively.
- Days to hatch or time to release of young: Hatching reached >90% in the control groups on Day 5 of the test, at which time the larvae were released to their respective test chambers. A few embryos in the negative control and 1.2 mg/L treatment groups remained in the incubation chambers until they hatched on Day 6 of the test.
- Numbers hatched, Numbers of offspring produced, or Number of offspring per live female per day: see Table 1: Summary of test results for apical endpoints
- Number of fish in swim-up stage at one or more time periods (e.g., day x1, x2): day 2: 0.13 mg/l x 1, 1.2 mg/l x2, day 9 and 11: 1,2 mg/l x 1
- Observations on body length and weight of young and/or exposed parents at one or more time periods: Table 1: Summary of test results for apical endpoints
- Number of healthy fish at end of test: control 63, 60 in the 0.13 mg/l, 73 in the 0.26 mg/l, 57 in the 0.54 mg/l, 63 in the 1.2 mg/l, none in the 2.4 mg/l.
- Effect concentrations exceeding solubility of substance in test medium: none
- Incidents in the course of the test which might have influenced the results: due to the ready biodegradation of the test substance modifications were made to the test protocol.

Reported statistics and error estimates:

Test endpoints analyzed statistically for the juvenile fish were hatching success, larval survival and growth of larvae that survived to test end (total length, wet weight and dry weight). The statistical analyses used to evaluate the data were based on the procedures provided in the OECD 210 guideline.
When the larvae were accidentally killed or injured and later died, they were excluded from the analysis of survival since the mortality was not treatment related.

The following conditions were used to judge whether the ECx values (e.g., EC10 or EC20) would be determined and reported:

1.) The test concentrations must bracket the ECx so that the ECx comes from interpolation rather than extrapolation.

2.) The ECx will be estimated so that (i) the 95% confidence interval reported for ECx does not contain zero and is not overly wide, (ii) the 95% confidence interval for the predicted mean at ECx does not contain the control mean, and (iii) there is no significant lack-of-fit of regression model to the data.

Since the above conditions for determining the EC10 and EC20 for survival and growth measured as dry weight were met, the EC10, EC20 and the corresponding 95% confidence intervals for these endpoints were reported (Table 5). When the above conditions for determining the EC10 and EC20 for hatching success and the EC20 for total length and wet weight were not satisfied (i.e. the ECx values and/or the corresponding 95% confidence interval were outside the data used for the estimation), the EC10 and EC20 for hatching success and the EC20 for total length and wet weight were not reported.

Table 1: Summary of test results for apical endpoints

Mean Measured Target Concentration (mg/L)	Number Exposed	Total Number Hatched	Hatching Success (%)	Number Surviving to Termination	Post-Hatch Survival (%)	Mean Total Length ± Std. Dev. (mm)	Mean Wet Weight ± Std. Dev. (mm)	Mean Dry Weight ± Std. Dev. (mm)
Negative Control	80	77	96	67	87	23.1 ± 0.38	105.1 ± 5.67	21.1 ± 0.75
0.13	80	78	96	69	88	21.8 ± 0.57^‡	91.2 ± 4.99^‡	18.1 ± 0.88^‡
0.26	80	80	100	73	91	22.9 ± 0.23	102.2 ± 4.55	21.4 ± 0.61
0.54	80	76	95	57	76	21.8 ± 0.87^‡	101.9 ± 2.56	21.1 ± 0.40
1.2	80	77	96	43	56*	20.7 ± 0.35^‡,Δ	89.7 ± 2.72^‡,Δ	19.0 ± 0.88^‡
2.4	80	80	100	2	3*	6.0 ± 1.41	1.5 ± 0.071	0.15 ± 0.071

The 2.4 mg/l treatment group was excluded from analyses of growth due to a significant effect on survival.

* Indicates a significant difference from the control (Fisher's Exact test, p≤0.05).

^‡Indicates a significance difference from the control (Dunnett's one-tailed test, p≤0.05).However,the total length, wet and dry weight in the 0.13 mg/l treatment concentrations did not follow a dose-response pattern and were not considered to be biologically meaningful.

 

^ΔIndicates a significance difference from the control (Jonckheere-Terpstra trend test, p≤0.05).

Table 2. Measured concentration of Decanol in Freshwater samples

Target Test Concentration (mg/L)	Sampling Number (774A-104-)	Sampling Time (Day)	Measured Concentration^1,2(mg/L)	Percent of Target^2	Mean Measured Concentration (mg/L)	Mean Measured Percent of Target
Negative Control	1	0	<LOQ	--	--	--
0	7	1	<LOQ	--
	13	5	<LOQ	--
	19	8	<LOQ	--
	25	12	<LOQ	--
	31	14	<LOQ	--
	37	20	<LOQ	--
	43	22	<LOQ	--
	49	27	<LOQ	--
	55	29	<LOQ	--
	61	33	<LOQ	--
0.13	2	0	0.158	121	0.13	100
	8	1	0.151	116	(%CV=22.1)
	14	5	0.143	110
	20	8	0.123	94.8
	26	12	0.117	90.1
	32	14	0.180	138
	38	20	0.103	79.3
	44	22	0.0909	69.9
	50	27	0.118	90.9
	56	29	0.101	77.7
	62	33	0.105	80.8
0.26	3	0	0.314	121	0.26	100
	9	1	0.336	129	(%CV=15.4)
	15	5	0.255	97.9
	21	8	0.238	91.7
	27	12	0.263	101
	33	14	0.308	118
	39	20	0.248	95.6
	45	22	0.197	75.8
	51	27	0.257	98.7
	57	29	0.220	84.7
	63	33	0.248	95.6
0.53	4	0	0.672	127	0.54	102
	10	1	0.627	118	(%CV=15.4)
	16	5	0.490	92.4
	22	8	0.493	93.0
	28	12	0.435	82.1
	34	14	0.628	119
	40	20	0.563	106
	46	22	0.539	102
	52	27	0.515	97.2
	58	29	0.430	91.2
	64	33	0.497	93.8
1.1	5	0	1.46	133	1.2	109
	11	1	1.44	131	(%CV=14.5)
	17	5	1.11	101
	23	8	1.2	109
	29	12	0.954	86.7
	35	14	1.37	125
	41	20	1.43	130
	47	22	1.26	115
	53	27	1.07	97.3
	59	29	1.05	95.5
	65	33	1.18	107
2.1	6	0	2.83	135	2.4	114
	12	1	2.85	136	(%CV=15.2)
	18	5	2.51	119
	24	8	2.08	99.1
	30	12	1.79	85.1
	36	14	2.46	115
	42	20	2.85	136
	48	22	2.31	110
	54	27	2.47	118
	60	29	2.22	106
	66	33	1.95	92.8

1. The limit of quantitation (LOQ) was 0.0250 mg/l, calculated as the product of the concentration of the lowest calibration standard (0 .0500 mg/l) and the dilution factor of the matrix blank samples (0 .500).


2. Results were generated using Excel 2010 in full precision mode. Manual calculations may differ slightly.

 

Validity criteria fulfilled:

yes

Remarks:

(The criteria for dissolved oxygen and temperature, and hatching and post-hatch success in controls were met; analytical measurement of test concentrations was performed)

Conclusions:

Reliable EC10 values of 0.43 mg/l based on survival to >2.4 mg/l based on hatched numbers and a NOEC value of 0.26 mg/l for growth based on total length (most sensitive endpoint) were determined for Pimephales promelas exposed to decan-1-ol in a reliable fish early life-stage test. The test was conducted in accordance with GLP and following OECD 210 with appropriate and necessary modifications due to the test substance being a very difficult substance to test. The result is considered definitive.

Executive summary:

Reliable EC₁₀ values of 0.43 - >2.4 mg/l and NOEC value of 0.26 mg/l for a range of appropriate endpoints were determined for Pimephales promelas exposed to decan-1-ol in a reliable fish early life-stage test. The test was conducted in accordance with GLP and following OECD 210 with appropriate and necessary modifications due to the test substance being a very difficult substance to test. The result is considered definitive.

 

Further testing is not considered necessary because the freshwater PNEC has been derived from the data with long-term toxicity to invertebrates (Daphnia).

Reference 2

Endpoint:

fish early-life stage toxicity

Type of information:

other: published data

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EPA OTS 797.1000 (Fish Early-life Stage Toxicity Test)

Deviations:

yes

Remarks:

duration of test only 7 days, test solution volume reduced to 250 ml/replicate; number of replicate chambers per concentration increased to 4, number of larvae/chamber increased to 15, maximum number of larvae per concentration increased to 60.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 11.9, 6.0 and 3.0 mg/L

- Sampling method: 3 grab samples were taken from initial test solution and 3 from the final test solution in the highest concentration and 0.75, 3.0 and 6.0 mg/L.

- Sample storage conditions before analysis: stored at 4 degC.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: 7 L of the high test concentration were prepared using 100 ul of 1-octanol (11.9 mg). The solution was then mixed by shaking for 10 min.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM

- Common name: fathead minnow

- Source: Fathead minnow culture unit at the EPA Newtown Facility.


METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish: the embryos were delivered to the testing facility on spawning tiles.

- Method of collection of fertilised eggs: tiles were transferred to hatching trays containing airstones.

- Subsequent handling of eggs: after 12 hrs the tiles and unhatched embryos were removed. Larvae hatched within this 12 hour period were pooled. This procedure was times so to obtain 1, 4 and 7 day larvae.


POST-HATCH FEEDING

- Start date: First day.

- Type/source of feed: concentrated brine shrimp nauplii.

- Amount given: 3 drops of shrimp once a day.

- Frequency of feeding: The larvae were fed once on the first day, twice daily on days 1 to 6 and not fed on the last day.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Hardness:

86-94 mg/L as CaCO3 at the beginning of the test

Test temperature:

25 ± 1 ºC

pH:

average: 7.5

Dissolved oxygen:

average: 6.0 mg/L (4.4 to 7.2 mg/L)

Salinity:

N.A.

Nominal and measured concentrations:

Nominal: 0.75, 1.5, 3.0, 6.0 and 11.9 mg/L
Measured: The initial measured concentration of the highest concentration was 113% of the nominal value (13.4 mg/L). The final measured concentration of the high concentration (11.9 mg/L) was 1.3 mg/L at the end of the test. See table 1 for details.

Details on test conditions:

TEST SYSTEM

- Test vessel: beakers

- Material, size, headspace, fill volume: 600 ml borosilicate glass beakers filled with 250 ml test solution

- No. of fertilized eggs/embryos per vessel: 10 larvae per vessel

- No. of vessels per concentration: 4

- No. of vessels per control: 4

- Biomass loading rate:


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Prepared with reagent grade chemicals added to a carbon-filtered, deionised Cincinnati tap water that was treated in a Millipore Milli-Q system, aerated vigorously for approx. 24 hours before usage

- Alkalinity: 56 - 64 mg/L as CaCO3

- Intervals of water quality measurement: daily



EFFECT PARAMETERS MEASURED: survival - daily; growth - end of test.


RANGE-FINDING STUDY

- Test concentrations: dilution factor of 0.5 in definitive study

Reference substance (positive control):

no

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

1.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: survival

Duration:

7 d

Dose descriptor:

LOEC

Effect conc.:

3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: survival

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

1.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

7 d

Dose descriptor:

LOEC

Effect conc.:

6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

- Mortality of control: Three side by side exposures were conducted with 1-octanol; survival of 1-d control larvae in the first set was only 78%, which is less than the acceptable criteria of 80% or greater control survival. However, the 1-d larvae test was analysed by declaring one of the replicates an outlier because only 1 larvae of 10 survived, while survival was 100% in the other three control replicates.

See table 1 for details on results.

Reported statistics and error estimates:

Dunett's test to analyse deviations from normality or homogeneity of variance; Boniferroni's test was used to analyse the control as a an outlier; Steel's many-one rank test was used if data has significant deviations from normality or homogeneity. The EPA fathead minnow program, v 1.2, was used to determine NOEC and LOEC on biomass and survival.

Table 1. Result of the three side-by-side tests using 1 d old larvae; (n=3 in control, n=4 in exposure vessels).

Test #	Survival (mg/L)		Growth (mg/L)
	NOEC	LOEC	NOEC	LOEC
1	6.0	11.9	3.0	6.0
2	1.5	3.0	1.5	ND
3	6.0	11.9	3.0	6.0

The lowest NOEC and LOEC are used to determine the toxicity of the test substance to fish larvae.

Table 2. Nominal and measured concentrations (average over 3 tests), analysed via GC-MS.

Nominal concentration (mg/L)	Measured concentration - initial (mg/L)	Measured concentration - final (mg/L)
0.0	-	-
0.75	-	0.0
1.5	-	-
3.0	-	0.0
6.0	-	0.075
11.9	11.4	1.3

The three grab samples of the initial nominal high test concentration of 11.9 mg/L were measured and the mean values was 96% of the nominal value, corresponding to 11.4 mg/L. Three grab samples taken of the final test solution at the highest concentration (11.9 mg/L) was 1.3 mg/L.

Measured concentrations of grab samples of final test concentration at 6.0 mg/L was 0.05 and 0.09 mg/L. 1 -Octanol was not detected at nominal concentrations of 3.0, 0.75 mg/L and in the control.

 

Validity criteria fulfilled:

yes

Conclusions:

7 day NOEC values equivalent to 1.5 mg/L were determined for the effects of the test substance on survival and growth of the larvae of freshwater fish Pimephales promelas.

Executive summary:

A NOEC of between 0.75 and 3.0 mg/L has been determined for growth reduction in a 7-day test with larval Fathead minnows (Pimephales promelas). The result is expressed relative to nominal exposure concentrations and it is significant to note that measured concentrations declined by >90% over the period between media renewals (not specified in the source document). The true toxicity is therefore likely to have been greater than that expressed due to the observed loss of test substance concentration in the old media. The duration of this test is too short for it to be considered a true chronic study.

Reference 3

Endpoint:

fish life cycle toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

QSAR prediction: US EPA accepted QSAR method for chemicals properties assessment.

Qualifier:

according to guideline

Guideline:

other: QSAR

Principles of method if other than guideline:

ECOSAR Program (v1.00)

GLP compliance:

no

Remarks:

not applicable to QSAR models

Analytical monitoring:

not required

Vehicle:

not specified

Test organisms (species):

other: Fish species

Details on test organisms:

no further information

Test type:

other: QSAR model

Water media type:

saltwater

Limit test:

no

Total exposure duration:

30 d

Hardness:

not applicable. QSAR model

Test temperature:

not applicable. QSAR model

pH:

not applicable. QSAR model

Dissolved oxygen:

not applicable. QSAR model

Salinity:

not applicable. QSAR model

Details on test conditions:

CAS Number: 67762-27-0
SMILES : CCCCCCCCCCCCCCCCO
CHEM : Alcohols, C16-18
MOL FOR: C16 H34 O1
MOL WT : 242.45
Log Kow: 6.73 (KowWin estimate)
Wat Sol: 0.0412 mg/L (experimental database)

Reference substance (positive control):

no

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0.028 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: non-toxic at the limit of solubility, as determined by (Q)SAR

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

280 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: Predicted, at water solubility loading rates of 1000 mg/L

Details on results:

A NOEC value of 0.028 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 280 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.028 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Overview of QSARs estimations on long-term aquatic toxicity of  Alcohols, C16-18 to fish

 

Method	Results	Remarks	Reference
QSAR estimate	Fish, 96-hr LC50 =0.013 mg/L (ppm) Fish, 96-hr (SW) LC50 =0.012 mg/L (ppm) Fish 30-day ChV = 0.00183 mg/L (ppm) Fish (SW) 30-day ChV = 0.028 mg/L (ppm)	Reliable with restrictions, QSAR estimated data	ECOSAR Program (v1.00)

 

Fish, 96-hr LC50 =0.013 mg/L (ppm)

Fish, 96-hr (SW) LC50 =0.012 mg/L (ppm)

Fish 30-day ChV = 0.00183mg/L (ppm)

Fish (SW) 30-day ChV = 0.028mg/L (ppm)

 

Fish 14-day LC50 = 0.014 mg/L (ppm)

 

 

Validity criteria fulfilled:

yes

Remarks:

US EPA accepted QSAR method for chemicals properties assessment.

Conclusions:

A NOEC value of 0.028 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 280 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.028 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Executive summary:

The ECOSAR QSAR model predicts that the NOEC for marine water fish would to be 0.028 mg/l .This result signifies that the test substance is not expected to be toxic at the limit of solubility.This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

A reliable NOEC value of 280 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.028 mg/L. Predicted to be non-toxic at the limit of solubility.

The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

 

Reference 4

Endpoint:

fish life cycle toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

QSAR prediction: US EPA accepted QSAR method for chemicals properties assessment.

Qualifier:

according to guideline

Guideline:

other: QSAR

Principles of method if other than guideline:

ECOSAR Program (v1.00)

GLP compliance:

no

Remarks:

not applicable to QSAR models

Analytical monitoring:

not required

Vehicle:

not specified

Test organisms (species):

other: Fish species

Details on test organisms:

no further information

Test type:

other: QSAR model

Water media type:

freshwater

Limit test:

no

Total exposure duration:

30 d

Hardness:

not applicable. QSAR model

Test temperature:

not applicable. QSAR model

pH:

not applicable. QSAR model

Dissolved oxygen:

not applicable. QSAR model

Salinity:

not applicable. QSAR model

Details on test conditions:

CAS Number: 67762-27-0
SMILES : CCCCCCCCCCCCCCCCO
CHEM : Alcohols, C16-18
MOL FOR: C16 H34 O1
MOL WT : 242.45
Log Kow: 6.73 (KowWin estimate)
Wat Sol: 0.0412 mg/L (experimental database)

Reference substance (positive control):

no

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0.002 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: non-toxic at the limit of solubility, as determined by (Q)SAR

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

18.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: Predicted, at water solubility loading rates of 1000 mg/L

Details on results:

A NOEC value of 0.00183 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 18.3 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00183 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Overview of QSARs estimations on long-term aquatic toxicity of  Alcohols, C16-18 to fish

 

Method	Results	Remarks	Reference
QSAR estimate	Fish, 96-hr LC50 =0.013 mg/L (ppm) Fish, 96-hr (SW) LC50 =0.012 mg/L (ppm) Fish 30-day ChV = 0.00183 mg/L (ppm) Fish (SW) 30-day ChV = 0.028 mg/L (ppm)	Reliable with restrictions, QSAR estimated data	ECOSAR Program (v1.00)

 

Fish, 96-hr LC50 =0.013 mg/L (ppm)

Fish, 96-hr (SW) LC50 =0.012 mg/L (ppm)

Fish 30-day ChV = 0.00183mg/L (ppm)

Fish (SW) 30-day ChV = 0.028mg/L (ppm)

 

Fish 14-day LC50 = 0.014 mg/L (ppm)

 

 

Validity criteria fulfilled:

yes

Remarks:

US EPA accepted QSAR method for chemicals properties assessment.

Conclusions:

A NOEC value of 0.00183 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 18.3 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00183 mg/L. Predicted to be non-toxic at the limit of solubility.

Executive summary:

The ECOSAR QSAR model predicts that the NOEC for freshwater fish would to be 0.00183 mg/l .This result signifies that the test substance is not expected to be toxic at the limit of solubility.This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

 

Description of key information

A NOEC value of 0.00183 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 18.3 mg/L has been calculated for the effects of the test substance towards freshwater fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00183 mg/L. Predicted to be non-toxic at the limit of solubility.
A NOEC value of 0.028 mg/L has been calculated for the effects of the test substance on the mortality of the marine water fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 280 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.028 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

18.3 mg/L

Marine water fish

Marine water fish

Dose descriptor:

NOEC

Effect concentration:

280 mg/L

Additional information

A NOEC value of 0.00183 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

A reliable NOEC value of 18.3 mg/L has been calculated for the effects of the test substance towards freshwater fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00183 mg/L. Predicted to be non-toxic at the limit of solubility.

A NOEC value of 0.028 mg/L has been calculated for the effects of the test substance on the mortality of the marine water fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

A reliable NOEC value of 280 mg/L has been calculated for the effects of the test substance towards fish taxonomic group. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.028 mg/L. Predicted to be non-toxic at the limit of solubility.

The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.