Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

08 - 23 Aug 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study period of 15 days does not meet the criteria of today standard methods recommending 21 days study duration. However the validity criteria stated in ECHA Guidance on information requirements and chemical safety assessment, Chapter R. were fulfilled (e.g. 80% survival in the control, surviving females produce three broods in 21 days or less, > 60 brood neonates per female in the control on average). Thus all requested endpoints could be determined (time to first brood, number of offspring produced per female, growth and survival) and NOELR values for survival or reproductive endpoints could be calculated. In accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7b the study is considered as valid.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: OECD guideline 202 "Daphnia sp. Acute Immobilization Test and Reproduction Test", Part 2 (1993)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

Only 15 d test duration; Adopted in 1998

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: One set of final and initial WAF samples was collected on day 14 for chemical analysis. WAF samples (initial and final) of the control, the lowest (24 mg/L), middle (242 mg/L), and highest ( 2570 mg/L) were collected in duplicate.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Generation of WAFs was carried out using a modification of the procedure developed by Anderson et al. (1974). Six individual WAF setups, one for each of the five exposure concentrations and one for control were prepared. An appropriate amount of test material was added to 2000 mL of Mobil Technical Center well water in each corresponding WAF aspirator bottle. Bottles were capped with parafilm and stirred for 20 h at room temperature. After stirring, the phases were allowed to separate for 4 h. 800 mL of the water phase were subsequently drained from the bottom spout.
- Differential loading: yes
- Controls: Mobil Technical Center well water without test material.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: The primary culture originated from Aquatic Research Organisms, Hampton, NH. The in-house culture had been maintained in the laboratory since June 19, 1996.
- Age of parental stock: Daphnids used for the test were less than 24 h old.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

15 d

Test temperature:

19.3-20.5 °C

pH:

7.84-8.41

Nominal and measured concentrations:

Nominal: 0, 24, 97, 242, 1018 and 2570 mg/L
Measured: Below the detection limit of 0.03 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL polystyrene cups with 40 mL of test solution
- Type (delete if not applicable): covered with a plexiglass sheet
- Renewal rate of test solution (frequency/flow rate): every 48 h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Mobil Technical Center well water
- Intervals of water quality measurement: at the beginning of the study and after every renewal period

OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark

EFFECT PARAMETERS MEASURED: immobilisation and reproduction

Reference substance (positive control):

no

Key result

Duration:

15 d

Dose descriptor:

EL50

Effect conc.:

> 2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

immobilisation

Key result

Duration:

15 d

Dose descriptor:

EL50

Effect conc.:

> 2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

reproduction

Key result

Duration:

15 d

Dose descriptor:

NOELR

Effect conc.:

2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

reproduction

Details on results:

- Mortality of parent animals: 0%

No effects were observed in the range of water solubility with an NOELR = 2570 mg/L (15 d) based on reproduction and immobilisation.

Table 1: Final total reproduction counts taken during the static renewal three-brood chronic toxicity study of the WAF of the test substance to Daphnia magna

Replicates	Control	Exposure Concentrations (ppm)
		24	97	242	1018	2570
A	89	107	102	125	109	112
B	94	113	111	101	135	127
C	115	123	129	120	88	68
D	108	92	92	125	130	109
E	124	122	127	100	123	118
F	117	120	116	121	125	127
G	115	98	0	124	142	129
H	89	79	102	103	128	129
I	114	128	136	102	79	116
J	128	151	140	56	130	116
Totals	1093	1133	1055	1077	1189	1151
Average	109	113	106	108	119	115
Std. Dev.	14	20	40	21	21	18

 

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 July to 15 August 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

see "Any other information on materials and methods incl. tables" for details.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

As above

Analytical monitoring:

yes

Details on sampling:

Analytical sampling
Sampling Intervals and Solution Composition:
Days 0, 6, 14, and 20 (new): Each treatment level and control prior to division into replicate vessels

Days 2, 8, 16, and 21 (aged): Composite of all available replicate vessels within each treatment level and control

Number Of Samples Taken from Each Exposure Solution: One sample at each interval. In addition, subsamples of the test solutions were also collected at each sampling interval and stored frozen as archive samples.

Sampling Location: Approximate midpoint from the surface, bottom, and sides of the vessel

Sampling Device: Pipet

Quality Control (QC) Samples: Three samples per sampling interval, prepared in dilution water at nominal concentrations approximating the test concentration range

Method of Analysis: Gas chromatography with mass spectrometry detection (GC-MSD)

Average Recovery Range: LOQ (0.000200 mg/L): 82.5 ± 10.1% (RSD: 12.3%)
High (100 mg/L): 104 ± 5.34% (RSD: 5.12%)
Total: 93.4 ± 13.8% (RSD: 14.8%)

Medium Used: Fortified laboratory well water

QC Sample Limit of Acceptance: 70.0 to 120%

QC samples were prepared in fortified laboratory well water at each sampling interval at nominal test substance concentrations approximating the test concentration range and remained with the exposure solution samples throughout the analytical process. Analysis of the QC samples was used to judge the precision and quality control maintained during the analytical process. All exposure solutions and QC samples were analyzed for test substance concentration using methodology validated at Smithers Viscient (DeVellis, 2018). Conditions and procedures used throughout the analysis of exposure solutions and QC samples during this study were similar to those used in the method validation study.

Vehicle:

no

Details on test solutions:

Representative samples of the dilution water source were analyzed periodically for the presence of pesticides, PCBs, and toxic metals by Eurofins Lancaster Laboratories Environmental, Lancaster, Pennsylvania (U.S. EPA, 1997). None of these compounds have been detected at concentrations that are considered toxic in any of the water samples analyzed, in agreement with ASTM (2007) standard practice. Daphnid cultures are maintained in water from the same source as the dilution water utilized in this study and have successfully survived and reproduced over several generations. The acceptable performance of the daphnid cultures, in combination with the previously mentioned analyses, confirmed the acceptability of this dilution water for use during the conduct of bioassays.

Test Concentrations
Selection of nominal concentrations for the chronic toxicity exposure with daphnids was based on the results of a 21-day preliminary exposure conducted under static-renewal conditions at Smithers Viscient and in consultation with the Study Sponsor.

Nominal Loading Rate Concentrations: 6.3, 13, 25, 50, and 100 mg/L (6.3, 13, 25, 50, and 100% of a 100 mg/L water accommodated fraction (WAF))
Co-Solvent: None
Co-Solvent Load: Not applicable

Solution Preparation
Primary Stock Concentration: 100 mg/L loading rate
Stock Vessel: Glass beaker
Stock Volume: 3.5 L
Diluent: Fortified laboratory well water
Amount of Test Substance Added (for example): 0.3495 g (tested as 100%)

The primary stock solution was prepared as a WAF by adding the aliquot of test substance directly to the total volume of dilution water in a glass beaker. The stock solution was observed to be clear and colorless with visible oily globules of the test substance floating on the surface of the solution. The solution was then covered with plastic wrap and mixed slowly with a Teflon coated stir bar and stir plate for a total mixing time of approximately 48 hours. Following mixing, the solution was observed to be clear and colorless with an oily globule of test substance on the surface of the solution. Approximately 2.5 L of the solution water-accommodated fraction (WAF) was then siphoned into a second 4.0-L glass beaker, avoiding the water surface. The resulting solution was observed to be clear and colorless with no visible undissolved test substance

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnids were selected as the test organism since they are recommended by OECD and are commonly used in chronic freshwater invertebrate toxicity tests. The Daphnia magna used in this toxicity test were obtained from laboratory cultures maintained at Smithers Viscient. Daphnids were obtained for testing by removing all immature daphnids from the culture vessel, thus isolating sexually mature daphnids approximately 24 hours prior to exposure initiation. Young produced by these daphnids within 24 hours of isolation were used in the exposure. The culture water was prepared by fortifying well water based on the formula for hard water (U.S. EPA, 1975) and filtering it through an Amberlite XAD 7 resin column to remove any potential organic contaminants.

Information on test organism
Species: Daphnia magna
Source: Smithers Viscient culture
Age: <24 hours old at exposure initiation
Culture Vessel: 1.0-L glass beaker containing 0.80 L of water
Food Type: unicellular green algae, Ankistrodesmus falcatus (4 × 107 cells/mL) and a suspension of YCT (yeast, cereal leaves, and flaked fish food)
Feeding Frequency: Once daily during culture

Culture Conditions Two Weeks Prior to Testing
Water Type: Fortified laboratory well water
pH: 7.9 to 8.4
Photoperiod: 16 hours light: 8 hours dark
Light Intensity: 41 to 68 footcandles (440 to 730 lux)
Temperature (°C): 20 to 22
Dissolved Oxygen: 7.1 to 8.9 mg/L
Conductivity ): 780 to 840 µS/cm
Total hardness as CaCO3 (mg/L): 160 to 180
Total alkalinity as CaCO3 (mg/L): 80 to 86

Representative samples of the food source were periodically analyzed for the presence of pesticides, PCBs, and toxic metals by Eurofins Lancaster Laboratories Environmental, Lancaster, Pennsylvania (U.S. EPA, 1997). None of these compounds have been detected at concentrations considered toxic in any of the samples analyzed, in agreement with ASTM (2007) standard practice. Based on the analysis for pesticides, the food source was considered to be of acceptable quality since all analyte concentrations were below levels of concern.

Test type:

static

Water media type:

other: Fortified laboratory well water

Remarks:

more information provided in "Details on test organisms"

Limit test:

yes

Total exposure duration:

21 d

Remarks on exposure duration:

The exposure was initiated when daphnids, <24 hours old, were impartially distributed to each of the ten replicates for each nominal concentration and control.

Post exposure observation period:

Not specified

Hardness:

As CaCO3 160 to 190 mg/L

Test temperature:

20 to 22 °C

pH:

7.9 to 8.4

Dissolved oxygen:

7.1 to 8.9 mg/L

Salinity:

Not specified

Conductivity:

800 to 870 µS/cm

Nominal and measured concentrations:

Nominal Loading Rate Concentrations: 6.3, 13, 25, 50, and 100 mg/L (6.3, 13, 25, 50, and 100% of a 100 mg/L water accommodated fraction (WAF))

Details on test conditions:

Temperature controlled by: Environmental chamber set to maintain temperature at 20 ± 2 °C
Duration: 21 days
Photoperiod: 16 hours light: 8 hours dark
Transition Period: 15- to 30-minute transition period was controlled with an automatic timer.
Light Intensity: 15 to 20 µE m-2 s-1 measured with a Licor Model LI 250A photometer
Bulb Type: Fluorescent bulbs
Food Type: Algal suspension (Ankistrodesmus falcatus; 4 x 107 cells/mL):
250 µL (test days 0 through 7),
300 µL (test days 8 through 15), and
350 µL (test days 16 through 21)
Yeast, cereal leaves, and digested flaked fish food (YCT) suspension: 50 µL
Equivalent to approximately 0.20 mg carbon/daphnid/day
Feeding Frequency: Once daily
Replication: Ten replicates per treatment level and the control, each labeled to identify the nominal test concentration and designated replicate (A through J)
Control of Bias: Impartial addition of daphnids
Aeration: None
Exposure Vessel Size/Material: 100-mL clear glass beakers
Exposure Vessel Solution Volume: 80 mL
Exposure Vessel Cleaning: Cleaned prior to initiation

Test Solution Renewal
At exposure initiation and at each renewal interval (every 48 hours throughout the 21-day exposure), fresh Hatcol 1510 solutions were prepared according to the method outlined. At each renewal period, freshly prepared test solution was added to a second set of 100-mL glass beakers until each vessel contained 80 mL of solution. On renewal days, daphnids were carefully transferred from the aged solution into the freshly prepared exposure solutions and the food suspensions were then added to the newly prepared solutions.

Biological Observations
The number of immobilized adult daphnids and observations of abnormal behavior were recorded daily. Immobilization is defined as the inability of daphnids to swim within 15 seconds of gentle agitation of the exposure vessel. Numbers of offspring were determined upon the first
brood release in any vessel and daily throughout the remainder of the test. Offspring were removed, counted, and discarded at each observation interval. In addition, the number of immobilized offspring and the time to first brood release were recorded for each treatment level
and control. Observations of physical characteristics of exposure solutions (e.g., precipitate, cloudy solution) were recorded whenever the test organisms were observed. At exposure termination (day 21), the total body length of each surviving adult daphnid was measured. Daphnids were measured (to the nearest 0.05 mm) from the apex of the head to the base of the shell spine using an Olympus SZH-ILLD-200 Stereoscope in combination with a calibrated ocular.

Reference substance (positive control):

not required

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF concentrations

Basis for effect:

other: Survival, reproduction, length

Key result

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF concentrations

Basis for effect:

other: Survival, reproduction, length

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF concentrations

Basis for effect:

other: Survivial, reproduction, length

Remarks on result:

other: EC value was empirically estimated; therefore, corresponding 95% confidence interval could not be determined.

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.001 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Survival, reproduction, length

Remarks on result:

other: No effects at the limit of solubility in water

Key result

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 0.001 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Survival, reproduction, length

Remarks on result:

other: No effects at the limit of solubility in water

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 0.001 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Survival, reproduction, length

Remarks on result:

other: EC value was empirically estimated; therefore, corresponding 95% confidence interval could not be determined.

Remarks:

No effects at the limit of solubility in water

Details on results:

21-Day Preliminary Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Mean Percent Survival, Reproduction, and Total Body Length of Parental Daphnids
Based on these results and in consultation with the Study Sponsor, nominal concentrations of 6.3, 13, 25, 50, and 100 mg/L (6.3, 13, 25, 50, and 100% of a 100 mg/L water accommodated fraction (WAF)), and a control were selected for the definitive static-renewal exposure. 
 
Prior to the definitive exposure, two initial definitive exposures were conducted at Smithers Viscient between July 2017 and January 2018. The first exposure was repeated due to analytical recoveries below the limit of quantitation (LOQ). The second exposure was repeated due to aged solution recoveries below the LOQ

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Concentrations Measured in Exposure Solutions
Solution concentrations decreased substantially over the course of each renewal period. The cause of these losses is unknown, but is likely related to adsorption or degradation and can be reliably attributed to the behavior of the test substance under the exposure conditions due to its inherent chemical properties. There was some variability in the measured concentrations of the individual WAF preparations (the new solutions in the table above). This is likely related to the inherent variability associated with the generation of samples at the limit of functional solubility. Considerable precautions were taken to minimize this potential variability associated with the WAF preparation, including factors such as maintaining consistent mixing time and mixing speed.
 
Analysis of 21 of the 24 QC samples resulted in measured concentrations which were consistent with the predetermined recovery range and ranged from72.3 was 120%of the nominal fortified concentrations (0.000200, 0.00200, and 0.0200 mg/L). These results established that the appropriate precision and quality control was maintained during the analysis of the exposure solutions. 
 
The recovery of one QC sample on day 0 was 160%, one QC on day 8 was 198%, and one QC on day 14 was 1210%, which are outside the established acceptance criterion (i.e., 70 to 120%). These results are likely due to fortification errors limited to these samples and not sample processing as the remaining QC sample results are well within the expected range and the recoveries of the exposure solutions maintain a consistent trend. Given the fact that the two remaining QC samples for each impacted interval are within the acceptable range and the likely cause of the failure is limited to the individual QC samples, the failure of these QC samples to meet acceptance criterion has minimal impact on the evaluation of test sample results. 

Based on the results of this study, the 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 100 mg/L and >100 mg/L, respectively, based on nominal loading rate WAF concentrations.
The 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 0.00085 mg/L and >0.00085 mg/L, respectively, based on mean measured active ingredient concentrations.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not specified

21-Day Preliminary Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Mean Percent Survival, Reproduction, and Total Body Length of Parental Daphnids

 

Nominal Concentration (mg/L)	Mean Percent Survival	Mean (SD)^aNumber of Offspring Released per Surviving Daphnid	Mean (SD) Number of Offspring Released per Female	Mean (SD)^a Total Body Length (mm)
Control	100	70 (24)	70 (24)	4.28 (0.32)
0.010	100	92 (11)	92 (11)	4.41 (0.10)
0.10	100	92 (6)	92 (6)	4.58 (0.07)
1.0	100	89 (28)	89 (28)	4.57 (0.08)
10	100	104 (21)	104 (21)	4.64 (0.10)
100	100	110 (46)	110 (46)	4.57 (0.13)

 

^a      SD = Standard Deviation

 

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Water Quality Parameters Measured in the Exposure Solutions

Nominal Concentration (mg/L loading rate WAF)		Ranges
		Dissolved Oxygen		Temperature (°C)^a	pH	Total Hardness (mg/L CaCO3)	Total Alkalinity (mg/L CaCO3)	Conductivity (µS/cm)
		(mg/L)	(% of Saturation)
Control	New	8.2 - 9.6	93 - 100	19 - 22	8.0 - 8.3	180	86	790 - 820
	Aged	8.4 - 11	94 - 120	19 - 21	7.9 - 8.8	190	88	860
6.3	New	8.2 - 9.4	92 - 100	19 - 22	8.0 - 8.3	NA^b	NA	NA
	Aged	8.2 - 10	93 - 120	20 - 21	8.0 - 8.8	NA	NA	NA
13	New	8.2 - 9.4	92 - 100	19 - 21	8.1 - 8.3	NA	NA	NA
	Aged	8.2 - 10	92 - 110	19 - 21	7.9 - 8.7	NA	NA	NA
25	New	8.2 - 9.3	92 - 100	19 - 21	8.1 - 8.3	NA	NA	NA
	Aged	7.9 - 11	88 - 120	19 - 21	7.9 - 8.7	NA	NA	NA
50	New	8.2 - 9.4	92 - 100	19 - 22	8.1 - 8.3	NA	NA	NA
	Aged	7.8 - 10.0	88 - 110	19 - 21	7.9 - 8.7	NA	NA	NA
100	New	8.3 - 9.5	92 - 100	19 - 22	8.1 - 8.3	180 - 200	88	760 - 860
	Aged	7.9 - 9.9	89 - 110	19 - 21	7.9 - 8.7	190	88	870

^a      Continuous temperature monitoring of the environmental chamber established a minimum/maximum temperature range of 19 to 20 °C during the exposure period.

^b      NA = Not Applicable; measurement not required by protocol.

 

NOTE:   Values presented have been rounded to two significant figures.

 

These results established that the water quality conditions throughout the exposure remained within acceptable ranges for the survival, reproduction, and growth of Daphnia magna.

 

 

Analytical Results

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Concentrations Measured in Exposure Solutions

 

Nominal Concentration (mg/L)	Measured Concentration (mg/L)
	Day 0 (new)	Day 2 (aged)	Day 6 (new)	Day 8 (aged)	Day 14 (new)	Day 16 (aged)	Day 20 (new)	Day 21 (aged)	Mean (SD)^a
Control	<0.000063^b	<0.000063	<0.000063	<0.000063	<0.000063	<0.000063	<0.000063	<0.000063	NA^c(NA)
6.3	<0.000063^d	<0.000063^d	0.000069	<0.000063^d	0.00016	<0.000063^d	0.000069	<0.000063^d	0.000057 (0.000045)
13	<0.000063^d	<0.000063^d	<0.000063^d	<0.000063^d	0.0016	0.000084	0.00018	<0.000063^d	0.00025 (0.00055)
25	<0.000063^d	<0.000063^d	0.00010	<0.000063^d	0.0031	0.00017	0.00023	<0.000063^d	0.00047 (0.0011)
50	0.00036	<0.000063^d	0.00023	<0.000063^d	0.0033	0.00027	0.00043	0.00012	0.00060 (0.0011)
100	0.00073	<0.000063^d	0.00044	<0.000063^d	0.0035	0.00055	0.0012	0.00022	0.00085 (0.0012)
QC^e#1 0.000200	0.000317 (160^f)	0.000173 (86.3)	0.000234 (117)	0.000395 (198^f)	0.000183 (91.4)	0.000217 (109)	0.000158 (78.9)	0.000227 (113)
QC #2 0.00200	0.00208 (104)	0.00171 (85.5)	0.00167 (83.3)	0.00225 (113)	0.00220 (110)	0.00184 (91.8)	0.00240 (120)	0.00186 (93.0)
QC #3 0.0200	0.0161 (80.5)	0.0179 (89.7)	0.0210 (105)	0.0178 (88.9)	0.243 (1210^f)	0.0145 (72.3)	0.0189 (94.5)	0.0155 (77.3)

^a      Mean measured concentration and standard deviation (SD) values were calculated using actual (unrounded) analytical results and not with the rounded values presented in this table. 

^b      Concentrations expressed as less than values were below the method detection limit (MDL). The MDL is dependent upon the lowest concentration calibration standard and the dilution factor of the controls. 

^c      NA = Not Applicable

^d         As a conservative measure, a value of ½ MDL was used for these samples to generate a mean measured concentration. See below for additional discussion. 

^e      QC = Quality Control sample; percent recovery is presented in parentheses.

^f          The percent recovery of this QC sample was outside of the acceptance criteria (i.e., 70.0 to 120%,).See below for additional discussion.

 

Biological Results

21-Day Chronic Exposure of Daphnids(Daphnia magna)to Hatcol 1510-Survival of Parental Daphnids and Number of Offspring Released per Female in the Control

Control
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	0	1	0	0	4	7	0	5	8	6	0	100
9	4	4	2	1	0	0	4	0	0	0	0	100
10	0	0	0	0	0	0	0	0	0/X	0	1	90
11	0	0	0	0	0	0	0	6	X	21	1	90
12	24	15	16	21	17/X	20	24	2	X	0	2	80
13	0	0	0	0	X	0	0	0	X	0	2	80
14	0	0	0	0	X	0	0	22	X	20	2	80
15	0	22	14	27	X	34	27	0	X	0	2	80
16	26	0	0	0	X	0	0	0	X	0	2	80
17	0	0	0	0	X	0	0	40	X	40	2	80
18	0	26	22	30	X	34	38	0	X	0	2	80
19	34	0	0	0	X	0	0	0	X	0	2	80
20	0	0	0	0	X	0	0	38	X	37	2	80
21	0	34	34	39	X	42	43	0	X	0	2	80
Total Number of Offspring Released per Surviving Female:
	88	102	88	118	NA	137	136	113	NA	124	Mean (N):	113 (8)
Total Number of Offspring Released per Female:
	88	102	88	118	21	137	136	113	8	124	Mean (N):	94 (10)

X = Immobilized daphnid

N = Number of daphnids evaluated

NA = Not Applicable

 

21-Day Chronic Exposure of Daphnids(Daphnia magna)to Hatcol 1510-Survival of Parental Daphnids and Number of Offspring Released per Female in the 6.3 mg/L Nominal Loading Rate WAF Treatment Level

6.3 mg/L nominal loading rate WAF
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	5	5	6	7	9	2	9	8	11	6	0	100
9	0	0	0	0	0	0	0	0	0	0	0	100
10	0	0	0	0	0	0	0	0	0	20	0	100
11	29	18	20	21	19	9	23	17	22	0	0	100
12	0	0	1	0	0	1	0	0	0	0	0	100
13	0	0	0	0	0	0	0	0	0	34	0	100
14	31	28	27	28	31	21	27	30	27	0	0	100
15	0	0	0	0	0	0	0	0	0	0	0	100
16	0	0	0	0	45	0	0	0	0/X	45	1	90
17	55	42	46	43	3	4	44	44	X	0	1	90
18	0	0	0	0	0	35	0	0	X	0	1	90
19	0	0	48	0	41	0	0	0	X	55	1	90
20	40	38	0	41	0	41	39	45	X	0	1	90
21	0	0	0	0	0	0	0	0	X	0	1	90
Total Number of Offspring Released per Surviving Female:
	160	131	148	140	148	113	142	144	NA	160	Mean (N):	143 (9)
Total Number of Offspring Released per Female:
	160	131	148	140	148	113	142	144	60	160	Mean (N):	135 (10)

X = Immobilized daphnid

N = Number of daphnids evaluated

NA = Not Applicable

 

21-Day Chronic Exposure of Daphnids(Daphnia magna)to Hatcol 1510-Survival of Parental Daphnids and Number of Offspring Released per Female in the 13 mg/L Nominal Loading Rate WAF Treatment Level

13 mg/L nominal loading rate WAF
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	0	0	5	9	7	0	6	0	7	0	0	100
9	8	0	0	0	0	6	0	8	0	5	0	100
10	0	0	26	19	0	0	0	0	0	0	0	100
11	0	23	0	0	25	0	0	0	27	0	0	100
12	26	0	0	0	0	27	16	22	0	27	0	100
13	0	0	36	32	0	0	0	0	0	0	0	100
14	0	31	0	0	34	0	0	0	34	0	0	100
15	34	0	0	0	0	40	32	43	0	43	0	100
16	0	0	50	48	0	1	0	0	0	0	0	100
17	0	42	0	0	52	0	0	0	48	0	0	100
18	43	0	0	0	0	41	33	44	0	41	0	100
19	0	0	56	55	0	0	0	0	0	0	0	100
20	0	42	0	0	40	0	0	0	46	0	0	100
21	46	0	0	0	0	0	34	48	0	44	0	100
Total Number of Offspring Released per Surviving Female:
	157	138	173	163	158	115	121	165	162	160	Mean (N):	151 (10)
Total Number of Offspring Released per Female:
	157	138	173	163	158	115	121	165	162	160	Mean (N):	151 (10)

N = Number of daphnids evaluated

 

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Survival of Parental Daphnids and Number of Offspring Released per Female in the 25 mg/L Nominal Loading Rate WAF Treatment Level

25 mg/L nominal loading rate WAF
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	0	0	0	0	0	0	0	0	0	0	0	100
9	6	7	4	4	8	5	7	9	1	10	0	100
10	0	0	0	0	0	0	0	0	0	0	0	100
11	0	0	0	0	0	0	0	0	0	0	0	100
12	31	30	26	25	38	27	30	29	24	40	0	100
13	0	0	0	0	0	0	0	0	0	0	0	100
14	0	0	0	0	0	0	0	0	0	0	0	100
15	42	41	43	34	42	0	40	37	22	52	0	100
16	0	0	0	0	0	33	27	0	0	0	0	100
17	0	0	0	0	0	0	0	0	0	0	0	100
18	41	39	42	40	46	47	35	41	38	50	0	100
19	0	0	0	0	0	2	0	0	0	0	0	100
20	0	0	0	0	0	0	0	0	0	0	0	100
21	48	46	50	41	46	43	40	46	50	53	0	100
Total Number of Offspring Released per Surviving Female:
	168	163	165	144	180	157	179	162	135	205	Mean (N):	166 (10)
Total Number of Offspring Released per Female:
	168	163	165	144	180	157	179	162	135	205	Mean (N):	166 (10)

N = Number of daphnids evaluated

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 - Survival of Parental Daphnids and Number of Offspring Released per Female in the 50 mg/L Nominal Loading Rate WAF Treatment Level

50 mg/L nominal loading rate WAF
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	0	12	0	0	0	10	5	10	9	8	0	100
9	11	0	5	10	7	0	0	0	0	0	0	100
10	0	0	0	0	0	0	0	22	0	0	0	100
11	6	25	0	0	0	19	27	0	25	21	0	100
12	24	0	29	32	25	0	0	0	0	0	0	100
13	0	0	0	0	0	0	0	28	0	0	0	100
14	38	33	26	16	0	32	39	0	33	33	0	100
15	0	0	11	22	43	0	0	0	0	0	0	100
16	0	0	0	0	0	0	0	46	0	0	0	100
17	49	50	47	0	0	45	53	0	48	41	0	100
18	0	0	0	48	44	0	0	0	0	0	0	100
19	0	0	0	0	0	0	0	50	0	0	0	100
20	48	50	51	0	0	48	52	0	51	49	0	100
21	0	0	0	48	45	0	0	0	0	0	0	100
Total Number of Offspring Released per Surviving Female:
	176	170	169	176	164	154	176	156	166	152	Mean (N):	166 (10)
Total Number of Offspring Released per Female:
	176	170	169	176	164	154	176	156	166	152	Mean (N):	166 (10)

N = Number of daphnids evaluated

 

21-Day Chronic Exposure of Daphnids(Daphnia magna)to Hatcol 1510-Survival of Parental Daphnids and Number of Offspring Released per Female in the 100 mg/L Nominal Loading Rate WAF Treatment Level

100 mg/L nominal loading rate WAF
Test Day	Number of Live Offspring Released per Replicate Exposure Vessel										Number of Adult Daphnids Immobilized	Mean Percent Survival
	A	B	C	D	E	F	G	H	I	J
0	0	0	0	0	0	0	0	0	0	0	0	100
1	0	0	0	0	0	0	0	0	0	0	0	100
2	0	0	0	0	0	0	0	0	0	0	0	100
3	0	0	0	0	0	0	0	0	0	0	0	100
4	0	0	0	0	0	0	0	0	0	0	0	100
5	0	0	0	0	0	0	0	0	0	0	0	100
6	0	0	0	0	0	0	0	0	0	0	0	100
7	0	0	0	0	0	0	0	0	0	0	0	100
8	11	13	11	12	11	12	12	10	10	6	0	100
9	0	0	0	0	0	0	0	0	0	6	0	100
10	0	0	0	30	0	31	25	0	0	0	0	100
11	32	30	27	0	25	0	0	30	30	0	0	100
12	0	0	0	0	0	0	0	0	0	26	0	100
13	0	0	0	46	0	41	33	0	0	0	0	100
14	44	38	37	0	33	0	0	37	40	32	0	100
15	0	0	0	0/X	0	0	0	0	0	0	1	90
16	0	51	51	X	0	57	49	0	0	0	1	90
17	54	0	0	X	48	0	0	58	54	45	1	90
18	0	0	0	X	0	0	0	0	0	0	1	90
19	0	52	52	X	0	59	56	0	0	0	1	90
20	54	0	0	X	52	0	0	55	48	53	1	90
21	0	0/P	0	X	0	0	0	0	0	0	1	90
Total Number of Offspring Released per Surviving Female:
	195	184	178	NA	169	200	175	190	182	168	Mean (N):	182 (9)
Total Number of Offspring Released per Female:
	195	184	178	88	169	200	175	190	182	168	Mean (N):	173 (10)

X = Immobilized daphnid

N = Number of daphnids evaluated

NA = Not Applicable

 

As demonstrated by the performance of the control, the exposure system provided conditions that were appropriate for promoting acceptable survival and reproduction of the test species and met the minimum standard criteria established by OECD guidelines (i.e.,³80% survival and³60 offspring per female). Time of the first brood release was within normal performance expectation for this species.

 

21-DayChronicExposure of Daphnids(Daphnia magna)to Hatcol 1510-Mean Body Length at Termination

Nominal Concentration (mg/L loading rate WAF)	Length (mm)
	Control	6.3	13	25	50	100
Replicate
A	4.45	4.75	4.55	4.50	4.80	4.75
B	4.30	4.55	4.65	4.55	4.70	4.60
C	4.50	4.60	4.70	4.60	4.75	4.75
D	4.10	4.60	4.65	4.60	4.75	NA
E	NA	4.30	4.70	4.75	4.70	4.75
F	4.45	4.45	4.50	4.70	4.70	4.70
G	4.35	4.30	4.50	4.60	4.70	4.75
H	4.50	4.50	4.70	4.60	4.65	4.85
I	NA	NA	4.75	4.60	4.70	4.90
J	4.60	4.70	4.70	4.70	4.65	4.75
Mean	4.41	4.53	4.64	4.62	4.71	4.76
SD^a	0.15	0.16	0.091	0.075	0.046	0.085

^a         SD = Standard Deviation

NA = Not Applicable

 

 

 

 

 

 

 

21-Day Chronic Exposure of Daphnids (Daphnia magna) to Hatcol 1510 –Nominal Loading Rate WAF Concentrations Tested, Mean Percent Survival, Number of Offspring per Surviving Female, Number of Offspring per Female, and Total Body Length of Parental Daphnids

Nominal Concentration (mg/L loading rate WAF)	Mean Percent Survival	Mean (SD^a) Number of Offspring Released per Surviving Female	Mean (SD) Number of Offspring Released per Female	Mean (SD) Total Body Length (mm)
Control	80	113^b(19)	94 (45)	4.41 (0.15)
6.3	90	143 (15)	135 (30)	4.53 (0.16)
13	100	151 (20)	151 (20)	4.64 (0.091)
25	100	166 (20)	166 (20)	4.62 (0.075)
50	100	166 (9.2)	166 (9.2)	4.71 (0.046)
100	90	182 (11)	173 (32)	4.76 (0.085)

^a      SD = Standard Deviation

^b      Coefficient of variation was 17%.

 

21-Day Chronic Exposure of Daphnids(Daphnia magna)to Hatcol 1510-Endpoint Summary

Results
	Endpoints (mg/L, based on nominal loading rate WAF concentrations)
	Survival	Reproduction (Total Living Offspring per Surviving Female)	Length
NOEC	100	100	100
LOEC	>100	>100	>100
EC10 (95% CI)	>100 (NA^a)	>100 (NA)	>100 (NA)
EC20 (95% CI)	>100 (NA)	>100 (NA)	>100 (NA)
EC50 (95% CI)	>100 (NA)	>100 (NA)	>100 (NA)

^a         NA = Not Applicable. EC value was empirically estimated; therefore, corresponding 95% confidence interval could not be determined.

CI = Confidence Interval

NOEC = No-Observed-Effect Concentration

LOEC = Lowest-Observed-Effect Concentration

Results
	Endpoints (mg/L, based on mean measured concentrations)
	Survival	Reproduction (Total Living Offspring per Surviving Female)	Length
NOEC	0.00085	0.00085	0.00085
LOEC	>0.00085	>0.00085	>0.00085
EC10 (95% CI)	>0.00085 (NA^a)	>0.00085 (NA)	>0.00085 (NA)
EC20 (95% CI)	>0.00085 (NA)	>0.00085 (NA)	>0.00085 (NA)
EC50 (95% CI)	>0.00085 (NA)	>0.00085 (NA)	>0.00085 (NA)

^a         NA = Not Applicable. EC value was empirically estimated; therefore, corresponding 95% confidence interval could not be determined.

CI = Confidence Interval

NOEC = No-Observed-Effect Concentration

LOEC = Lowest-Observed-Effect Concentration

 

ACCEPTABILITY CRITERIA

The following criteria are required for a test to be acceptable:

Acceptability Criteria	Study Results	Criterion Met (Yes/No)
Immobilization of parental daphnids in the control will be≤20%.	Immobilization of parental daphnids in the control was 20%	Yes
Mean number of live offspring produced per parental daphnid in the control will be≥60.	Mean number of live offspring produced per surviving parental daphnid in the control was 113	Yes
Coefficient of variation around the mean number of living offspring produced per parent animal in the control should be≤25%.	Coefficient of variation around the mean number of living offspring produced per surviving parent daphnid in the control was17%	Yes
Ephippia should not be present.	Ephippia were not observed.	Yes

 

 

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of this study, the 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 100 mg/L and >100 mg/L, respectively, based on nominal loading rate WAF concentrations.
The 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 0.00085 mg/L and >0.00085 mg/L, respectively, based on mean measured active ingredient concentrations, indicatting that there were no effects at the limit of solubility in water.

Executive summary:

The objective of this study was to evaluate the chronic effects of decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane (Hatcol 1510) on the survival, reproduction, and growth (mean total body length) of the daphnid, Daphnia magna.

The exposure was performed under static-renewal conditions for a period of 21 days.  Results of this study were used to determine the No-Observed-Effect Concentration (NOEC) and Lowest Observed-Effect Concentration (LOEC) for the most sensitive biological parameter monitored (e.g., daphnid survival, reproduction, and total body length).  In addition, a median effective concentration (EC50), EC20, and EC10 values for survival, reproduction, and growth (total body length) were determined.  The results of this study are based on nominal loading rate WAF and mean measured concentrations of Hatcol 1510

Based on the results of this study, the 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 100 mg/L and >100 mg/L, respectively, based on nominal loading rate WAF concentrations.  

The 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 0.00085 mg/L and >0.00085 mg/L, respectively, based on mean measured concentrations , indicating that there were no effects at the limit of solubility in water.  

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Reason / purpose for cross-reference:

read-across source

Reference substance (positive control):

not required

Key result

Duration:

15 d

Dose descriptor:

EL50

Effect conc.:

> 2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

immobilisation

Remarks on result:

other: CAS 11138-60-6

Key result

Duration:

15 d

Dose descriptor:

EL50

Effect conc.:

> 2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

reproduction

Remarks on result:

other: CAS 11138-60-6

Key result

Duration:

15 d

Dose descriptor:

NOELR

Effect conc.:

2 570 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

reproduction

Remarks on result:

other: CAS 11138-60-6

Validity criteria fulfilled:

not applicable

Remarks:

Read-across

Conclusions:

The substance, CAS 68130-53-0; EC 268-596-7, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of long-term toxicity to aquatic invertebrates. The substance is not considered to be toxic to aquatic invertebrates following long term exposure on the basis of read across.

Description of key information

21 day reproduction study using the test substance revealed that no toxicity was observed in daphnia magna above the limit of solubility.

A 15-day reproduction test with read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, showed no effects in the range of water solubility with an NOELR = 2570 mg/L (15 d) based on reproduction and immobilisation. Therefore, by read-across, the test substance is not expected to cause long-term toxicity in aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Decanoic acid, mixed esters with heptanoic acid, octanoic acid, and trimethylolpropane - Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static-Renewal Conditions

The objective of this study was to evaluate the chronic effects of decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane (Hatcol 1510) on the survival, reproduction, and growth (mean total body length) of the daphnid, Daphnia magna.

The exposure was performed under static-renewal conditions for a period of 21 days.  Results of this study were used to determine the No-Observed-Effect Concentration (NOEC) and Lowest Observed-Effect Concentration (LOEC) for the most sensitive biological parameter monitored (e.g., daphnid survival, reproduction, and total body length).  In addition, a median effective concentration (EC50), EC20, and EC10 values for survival, reproduction, and growth (total body length) were determined.  The results of this study are based on nominal loading rate WAF and mean measured concentrations of Hatcol 1510

Based on the results of this study, the 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 100 mg/L and >100 mg/L, respectively, based on nominal loading rate WAF concentrations.  

The 21 day No-Observed-Effect Concentration (NOEC) and Lowest-Observed-Effect Concentration (LOEC) for all endpoints were determined to be 0.00085 mg/L and >0.00085 mg/L, respectively, based on mean measured concentrations , indicating that there were no effects at the limit of solubility in water.  

Read across

A 15-day reproduction test with read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, showed no effects in the range of water solubility with an NOELR = 2570 mg/L (15 d) based on reproduction and immobilisation. The study period of 15 days does not meet the criteria of current recommendations regarding a 21 day study duration. However the validity criteria stated in ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7b were fulfilled (e.g. 80% survival in the control, surviving females produce three broods in 21 days or less, > 60 brood neonates per female in the control on average). Thus all requested endpoints could be determined (time to first brood, number of offspring produced per female, growth and survival) and NOELR values for survival or reproductive endpoints could be calculated. In accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7b the study is considered as valid.

A report justifying the read-across approach is included in IUCLID Chapter 13.