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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-07-10 to 2012-08-03
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:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.25 - 0.50 - 1.00 - 2.00 - 4.00 mg/L
- Sampling method: All concentration levels of the test item and the control were analysed at least once within 7 days in the fresh (0 hours) and old media (48 or 72 hours). For the longest exposure interval of 72 hours samples were taken from the fresh (0 hours) and old media (72 hours) once within the test period.
For the analyses of the old media, separate replicates without algae and daphnids were prepared and stored under test conditions.
At the end of the study, sorption to the glassware of the test vessels was determined exemplarily in a test vessel, which contained algae and daphnids at a concentration level close to the EC10. The vessel was carefully rinsed with dechlorinated water to remove remaining algae and test medium.
- Sample storage conditions before analysis: All original samples were stored at room temperature until sample preparation, if necessary. Prepared samples were stored at room temperature until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution (4.00 mg/L of the test item was weighed out) was prepared one day before application by directly weighing of the test item into a glass flask and adding an appropriate volume of the test medium.
The pH of the test medium was adjusted with 1 M HCl to pH 2 ± 0.2. The actual pH-values were in the range of pH 2.16 to 2.20. Thereafter, the stock solutions were stirred with 1100 rpm for 24 hours at 50 °C.
The pH of the stock solution was re-adjusted to pH 7 ± 0.2 (actual pH-values were in the range of 6.80 to 7.04) with 1 M NaOH before use in the test.
- Eluate: Dilution water
- Differential loading: 0.25 - 0.50 - 1.00 - 2.00 - 4.00 mg/L
- Controls: 10 replicates of dilution water without test item
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Clone 5
- Justification for species other than prescribed by test guideline: Daphnia magna STRAUS is recommended in the guideline
- Source: Own breeding (Origin: Institut fuer Wasser- Boden- und Lufthygiene)
- Age of parental stock (mean and range, SD): > 14 days
- Feeding during test
- Food type: Mix of Pseudokirchneriella subcapitata and Desmodesmus subspicatus
- Amount: 0.2 mg C/daphnia per day
- Frequency: daily


ACCLIMATION
- Acclimation period: 2 h in dilution water
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: During acclimation the daphnids were not fed
- Feeding frequency: None
- Health during acclimation (any mortality observed): Healthy

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: The parent animals were removed from the culture medium and the juveniles collected over a sieve and flushed into fresh medium
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
Not observed
Hardness:
Total Hardness [mg/L] as CaCO3
Nominal
Test item
Concentration
[mg/L] I F I F I F
Day 0 Day 2 Day 9 Day 12 Day 19 Day 21
2012-07-11 2012-07-13 2012-07-20 2012-07-23 2012-07-30 2012-08-01
4.00 153 148 n.a. n.a. n.a. n.a.
2.00 — — 142 146 176 176
Control 151 148 167 157 167 167
Test temperature:
Temperature [°C]
Nominal
Test item
Concentration
[mg/L] I F I F I F
Day 0 Day 2 Day 9 Day 12 Day 19 Day 21
2012-07-11 2012-07-13 2012-07-20 2012-07-23 2012-07-30 2012-08-01
4.00 22.0 21.4 n.a. n.a. n.a. n.a.
2.00 — — 22.0 21.7 21.9 21.4
Control 21.8 21.1 21.9 21.9 21.6 21.6
pH:
pH-Values
Nominal
Test item
Concentration
[mg/L] I F I F I F
Day 0 Day 2 Day 9 Day 12 Day 19 Day 21
2012-07-11 2012-07-13 2012-07-20 2012-07-23 2012-07-30 2012-08-01
4.00 7.04 7.31 n.a. n.a. n.a. n.a.
2.00 — — 7.57 7.50 7.04 7.33
Control 7.79 7.62 8.00 7.64 8.10 7.53
Dissolved oxygen:
Dissolved Oxygen Concentration [mg/L]
Nominal
Test item
Concentration
[mg/L] I F I F I F
Day 0 Day 2 Day 9 Day 12 Day 19 Day 21
2012-07-11 2012-07-13 2012-07-20 2012-07-23 2012-07-30 2012-08-01
4.00 6.59 7.38 n.a. n.a. n.a. n.a.
2.00 — — 8.49 6.78 8.47 7.29
Control 8.55 7.77 8.51 8.05 8.72 7.82
Salinity:
Not measured, freshwater
Nominal and measured concentrations:
Please refer to "Any other information on materials and methods"
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: 100 mL glass beaker, filled with 50 mL test solution
- Aeration: No
- Renewal rate of test solution (frequency): 3 x per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control and pH-control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Natural river water of the river Innerste was used. This river is located near 31157 Sarstedt-Ruthe, Germany (52.25°, 9.83°). The natural river water was stored at 15 ± 2 °C until use in the test. The test medium was homogenized by agitation prior to use.
Water Parameters of the Natural River Water
River Innerste
Location Amtshof K514, km 26,
31157 Ruthe-Sarstedt, Germany
Latitude:52.25°, Longitude: 9.83°
Sampling Date 2012-03-20
Weather on Day of Sampling Sunny, slightly clouded; approx. 15°C
Colour Yellowish to brownish, clear
pH 7.93
Conductivity [µS/cm] 856
Dissolved Oxygen [mg O2/L] 11.2
DOC [mg C/L] 2.80*
TOC [mg C/L] 3.66*
Ammonium-N [mg N/L] 0.07
Nitrate-N [mg N/L] 3.40
Total Nitrogen [mg N/L] 3.80
o-Phosphate-p [mg P/L] < 0.20
Total Phosphate [mg P/L] < 0.20
Suspended Matter [mg/L] 14.0
Total Hardness [mg CO3/L] 271
Storage conditions 15 ± 2°C


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light : 8 h dark per day
- Light intensity: Max. 20 µE*m-2*s-1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Adult mortality: daily
- Number of juveniles: daily
- Stillborn juveniles and aborted eggs: daily
- Appearance of first brood
- Intrinsic rate of natural increase: test end
- Growth (total length and dry weight): test end


RANGE-FINDING STUDY
Immobilization Rates in the Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal
Concentration
of the Test Item
[mg/L] IMMOBILIZATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
100 100 100 100 100 100 100
10 100 100 100 100 100 100
1 0 0 0 0 0 0
Control 0 0 0 0 0 0

Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
95.3% active ingredient
Basis for effect:
reproduction
Remarks on result:
other: (1 - 2)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.22 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Remarks on result:
other: (0.953 - 1.91)
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
1.91 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: (1.89 - 1.93)
Details on results:
- Mortality of parent animals:
The test item induced biologically significant adult mortality in concentration levels of 2.00 mg/L (50%) and 4.00 mg/L (100%) after 21 days. In the concentration levels 0.250 to 1.00 mg/L and in the control all parental daphnids survived till the end of the test after 21 days.
The EC10-value for the adult mortality was calculated by sigmoidal dose-response regression to be 1.47 mg/L. The EC50-value was calculated to be 2.00 mg/L (95 % confidence limits: 1.98 – 2.02 mg/L).
- No. of offspring produced per day per female:
The first brood was released till day 9 by all parent animals of the control and the concentration levels of 0.250 to 1.00 mg/L. The surviving parental daphnids in the concentration level of 2.00 mg/L released their first brood between day 10 and 14, which is regarded to be biologically significant delayed.
In the tested concentration levels of 0.250 to 1.00 mg/L and in the control 5 broods were produced by the surviving parental daphnids. In the concentration level of 2.00 mg/L, 2 to 4 broods were produced by the surviving parental daphnids.
The average number of living juveniles per surviving parent at the end of the test after 21 days was 177 in the control group. The reproductive output was statistically significant increased (+19 % in comparison to the control) at the concentration level of 1.00 mg/L and statistically significant reduced (-63 % in comparison to the control) at the concentration level of 2.00 mg/L (One Way Analysis of Variance, DUNNETT’S method, p = 0.05). In the concentration levels of 0.25 and 0.500 mg/L, the reproductive output was comparable to the reproductive output in the control. At the concentration level of 4.00 mg/L, no living juveniles were observed due to 100 % adult mortality.
The coefficient of variation of the number of living offspring produced per parent was 6 % in the control. In the concentration levels of 0.250 to 1.00 mg/L, the coefficient of variation was in the range of 2 to 8 %, which is comparable to the control.
A coefficient of variation above 25 % is regarded to be biological significant. A coefficient of variation of 71 % was observed at the concentration level of 2.00 mg/L. For the concentration level of 4.00 mg/L no coefficient of variation was calculated, because no offspring occurred due to 100 % adult mortality.
The No Observed Effect Concentration (NOECReproduction) after 21 days was assessed at 0.500 mg/L. The Lowest Observed Effect Concentration (LOECReproduction) was assessed at 1.00 mg/L.
In the tested concentration range, both significant increase and significant reduction of the reproductive output were observed. Therefore, standard methods for calculating the EC-values were not applicable. The EC10- and the EC50-value for the reduction of the reproductive output were estimated from the linear relation between the concentration level of 1.00 mg/L showing the maximum increase of the reproductive output in the tested concentration range, and the concentration level of 2.00 mg/L showing the maximum reduction of the reproductive output.
The EC10-value for the reduction of the reproductive output was estimated to be 1.28 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L). The EC50-value for the reduction of the reproductive output estimated to be 1.79 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L)
- Body length and weight of parent animals:
please refer to the respective table
- Type and number of morphological / behavioural abnormalities:
No stillborn juveniles and aborted eggs were produced by the control group during the exposure period of 21 days. Related to the total number of produced juveniles (dead + alive) the percentage of dead juveniles was < 3 % in the tested concentration levels of 0.250 to 2.00 mg/L with surviving parental daphnids.
- Time to first brood release or time to hatch:
The first brood was released till day 9 by all parent animals of the control and the concentration levels of 0.250 to 1.00 mg/L. The surviving parental daphnids in the concentration level of 2.00 mg/L released their first brood between day 10 and 14, which is regarded to be biologically significant delayed.
In the tested concentration levels of 0.250 to 1.00 mg/L and in the control 5 broods were produced by the surviving parental daphnids. In the concentration level of 2.00 mg/L, 2 to 4 broods were produced by the surviving parental daphnids. In the concentration level of 4.00 mg/L no juveniles occurred due to 100 % adult mortality






Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: EC50 (24 h) = 1.79 (CI 1.56 - 2.02) mg/L
Reported statistics and error estimates:
The NOEC and the LOEC based on the reproductive output as
EVALUATION the most sensitive effect in this study and the adult mortality were determined directly from the observation data. Significant deviations were determined in comparison to the control using statistical standard procedures as normality test, equal variance test and analysis of variance (ANOVA, DUNNETT’S method).
Prior to running the analysis of variance (ANOVA), a normality test and an equal variance test were performed. P-values of the normality and equal variance tests were nominal set to 0.05. The a-value (acceptable probability of incorrectly concluding that there is a difference) was a=0.05.
For the determination of significant deviations of the reproduction rates and the body lengths, One Way Analysis of Variance, DUNNETT’S method (p = 0.05) was used. Statistical evaluation of the intrinsic rates of natural increase was carried out using KRUSKAL-WALLIS, One Way Analysis of Variance on Ranks, DUNN’S method (p < 0.05).
The coefficients of variation around the mean number of living offspring produced per parent in the control and the test groups were evaluated.

Number of Juveniles in the Control and Test Groups after 21 Days

Nominal

Conc.

[mg/L]

No.

of

Parents

prod. Juv.

Mean No. of Juveniles

per Parent

producing Juveniles

Comparison

versus

Control

Number of Juveniles in Replicate No.

Total

No.

CV

Red.

Stat.

  1

  2

  3

  4

  5

  6

  7

  8

  9

   10

å

N

MV ± SD

[%]

[%]

4.00

--

--

--

--

--

--

--

--

--

--

--

  0

--

--

--

--

2.00

--

--

132

  13

  39

--

  92

  53

--

--

  329

  5

66 ±

47

71*

63

yes

1.00

207

207

203

197

224

233

204

226

216

188

2105

10

211 ±

14

  7

-19

yes

0.500

208

213

169

219

175

188

204

187

189

204

1956

10

196 ±

17

  8

-11

no

0.250

180

169

169

177

173

171

174

177

179

172

1741

10

174 ±

  4

  2

2

no

Control

183

174

163

190

161

171

173

180

193

180

1768

10

177 ±

11

  6

First Appearance of Living Juveniles and Mean Number of Broods

Nominal

Test Item Concentration

[mg/L]

Day of First Appearance of Living Juveniles

First

Mean

in Replicate No.

Appearance

Number

1

2

3

4

5

6

7

8

9

10

Mean Day

of Broods

4.00

--

--

--

--

--

--

--

--

--

--

--

--

2.00

--

--

10

14

11

--

11

10

--

--

11.2

3.4

1.00

9

8

  8

  8

  8

8

  8

  8

8

8

  8.1

5.0

0.500

8

8

  7

  8

  8

8

  8

  8

8

8

  7.9

5.0

0.250

8

8

  8

  8

  8

8

  8

  8

8

8

  8.0

5.0

Control

8

8

  8

  8

  8

8

  8

  8

8

8

  8.0

5.0

Relative Number of Dead (Stillborn + Aborted Eggs) to Total Number of Juveniles

Nominal

Test Item Concentration

[mg/L]

Number of Juveniles

Percentage of

Dead Juveniles#)

[%]

Dead

Alive

Total

4.00

--

--

--

--

2.00

10

  329

  339

2.95

1.00

20

2105

2125

0.941

0.500

32

1956

1988

1.61

0.250

  8

1741

1749

0.457

Control

  0

1768

1768

0

Mortality [%] of the Adult Daphnids after 7, 14 and 21 Days of Exposure

                 (n = 10)

Nominal

Test Item Concentration

[mg/L]

Adult Mortality [%]

7 days

14 days

21 days

4.00

1001)

1001)

1001)

2.00

  301)

  401)

  501)

1.00

   0

   0

   0

0.500

   0

   0

   0

0.250

   0

   0

   0

Control

   0

   0

   0

Total Body Length of the Parental Daphnids

Nominal

Test Item

Concentration

[mg/L]

Total Length of the Parent Animals

[mm]

MV

N

Dry Weight
[mg]

Replicate No.

1

2

3

4

5

6

7

8

9

10

[mm]

S

MV

4.00

--

--

--

--

--

--

--

--

--

--

--

  0

--

--

2.00

--

--

5.75

4.25

4.50

--

5.25

5.00

--

--

  4.95*

  5

  3.9

  0.780

1.00

5.50

6.00

6.25

5.75

6.00

6.25

5.75

5.25

5.75

5.50

5.80

10

10.4

1.04

0.500

6.25

5.75

5.75

6.00

5.75

6.25

6.00

6.00

6.25

6.00

6.00

10

11.4

1.14

0.250

5.75

6.00

5.75

5.75

6.00

6.00

6.00

6.00

5.75

6.00

5.90

10

12.5

1.25

Control

6.25

6.00

5.75

5.75

6.25

6.25

6.00

5.50

6.00

6.00

5.98

10

12.4

1.24

Validity criteria fulfilled:
yes
Conclusions:
The reproductive output was the most sensitive effect in this study. Statistically significant increase (hormesis) and reduction of the reproductive output was observed.
The No Observed Effect Concentration (NOECReproduction) after 21 days was assessed at 0.500 mg/L. The Lowest Observed Effect Concentration (LOECReproduction) was assessed at 1.00 mg/L. The EC10-value for the reduction of the reproductive output was estimated to be 1.28 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L). The EC50-value for the reduction of the reproductive output estimated to be 1.79 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L).
The EC10-value for the adult mortality was calculated by sigmoidal dose-response regression to be 1.470 mg/L. The EC50-value was calculated to be 2.00 mg/L (95 % confidence limits: 1.98 – 2.02 mg/L).


Endpoints assessed
3-(Isodecyloxy)propylamine (CAS no. 30113-45-2)
Nominal Concentration
[mg/L]
NOECReproduction 0.500 mg/L
LOECReproduction 1.00 mg/L
EC10, Reproduction 1.28 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L)
EC50, Reproduction 1.79 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L)
EC10 Adult Mortality 1.47 mg/L (95 % confidence limits: 1.44 – 1.49 mg/L)
EC50 Adult Mortality 2.00 mg/L (95 % confidence limits: 1.98 – 2.02 mg/L)
EC100 Adult Mortality 4.00 mg/L
Executive summary:

The Daphnia magna Reproduction Test (semi-static, 21 d) of the test item 3-(Isodecyloxy)propylamine (CAS No. 30113-45-2) (batch number: 890000022898) was conducted according to OECD 211 (2008) from 2012-07-10 to 2012-08-03, with the definitive exposure phase from 2012-07-11 to 2012-08-01, at Dr.U.Noack-Laboratorien, Käthe-Paulus-str. 1, 31157Sarstedt, Germany.

Test species was Daphnia magna STRAUS (Clone 5). Ten daphnids, individually held, were used per concentration level, and control. At test start the daphnids were 2 to 24 hours old. The study was carried out undersemi-static conditions with renewal of the test solutions three times per week. Aim of the Daphnia Reproduction Test over 21 days was to assess effects on the reproduction capacity and other test item-related effects or parameters such as time of production of first brood, adult mortality, intrinsic rate of natural increase, occurrence of aborted eggs and stillborn juveniles and body length of the parental daphnids.

Nominal concentrations of 3-(Isodecyloxy)propylamine (CAS No. 30113-45-2) were selected as follows: 0.250 - 0.500 - 1.00 - 2.00 - 4.00 mg/L.

The tested concentration levels of the test item 3-(Isodecyloxy)propylamine (CAS No. 30113-45-2) and the control were analytically verified by LC-MS/MS of samples on days 0, 9, 19 (fresh media, 0 hours), on days 2, 21 (old media, 48 hours) and on day 12 (old media, 72 hours).

The measured concentrations of 3-(Isodecyloxy)propylamine (CAS No. 30113-45-2) were in the range of 84 to 113 % of the nominal values in the fresh media (0 h) and 82 to 98 % in the old media (48 and 72 h). Therefore, all results given are based on the nominal concentrations of the test item.

Additionally, the sorption to the glassware in a test vessel which contained algae and daphnids at the concentration level of 1.00 mg/L was determined to be 2 %.

·   The average number of living juveniles per surviving parent at the end of the test after 21 days was 177 in the control group. The reproductive output was statistically significant increased (+19 % in comparison to the control) at the concentration level of 1.00 mg/L and statistically significant reduced (-63 % in comparison to the control) at the concentration level of 2.00 mg/L (One Way Analysis of Variance, Dunnett’s method, p = 0.05). In the concentration levels of 0.25 and 0.500 mg/L, the reproductive output was comparable to the reproductive output in the control. At the concentration level of 4.00 mg/L, no living juveniles were observed due to 100 % adult mortality.

·   The No Observed Effect Concentration (NOECReproduction) after 21 days was assessed at 0.500 mg/L. The Lowest Observed Effect Concentration (LOECReproduction) was assessed at 1.00 mg/L. The EC10-value for the reduction of the reproductive output was estimated to be 1.28 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L). The EC50-value for the reduction of the reproductive output estimated to be 1.79 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L).


·   The coefficient of variation of the number of living offspring produced per parent was 6 % in the control. In the concentration levels of 0.250 to 1.00 mg/L, the coefficient of variation was in the range of 2 to 8 %, which is comparable to the control.

A coefficient of variation above 25 % is regarded to be biological significant. A coefficient of variation of 71 % was observed at the concentration level of 2.00 mg/L. For the concentration level of 4.00 mg/L no coefficient of variation was calculated, because no offspring occurred due to 100 % adult mortality.

·   The intrinsic rates of natural increase (IR) of the surviving parent animals accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The mean IR of the surviving daphnids of the treatment groups were compared to the control by Kruskal-WallisOne Way Analysis of Variance on Ranks, Dunn’smethod (p  0.05). There was a statistical significance at the concentration level of 2.00 mg/L in comparison to the control. For the concentration level of 4.00 mg/L no IR was calculated, because no offspring occurred due to 100 % adult mortality.

·   The first brood was released till day 9 by all parent animals of the control and the concentration levels of 0.250 to 1.00 mg/L. The surviving parental daphnids in the concentration level of 2.00 mg/L released their first brood between day 10 and 14, which is regarded to be biologically significant delayed.
In the tested concentration levels of 0.250 to 1.00 mg/L and in the control 5 broods were produced by the surviving parental daphnids. In the concentration level of 2.00 mg/L, 2 to 4 broods were produced by the surviving parental daphnids. In the concentration level of 4.00 mg/L no juveniles occurred
due to 100 % adult mortality .

·   No stillborn juveniles and aborted eggs were produced by the control group during the exposure period of 21 days. Related to the total number of produced juveniles (dead + alive) the percentage of dead juveniles was 3 % in the tested concentration levels of 0.250 to 2.00 mg/L with surviving parental daphnids.

·   The test item induced biologically significant adult mortalityin concentration levels of

2.00 mg/L (50%) and 4.00 mg/L (100%) after 21 days.In the concentration levels 0.250 to 1.00 mg/L and in the control all parental daphnids survived till the end of the test after 21 days.
The EC10-value for the adult mortality was calculated by sigmoidal dose-response regression to be 1.47 mg/L. The EC50-value was calculated to be 2.00 mg/L (95 % confidence limits: 1.98 – 2.02 mg/L).


·   The mean values of the body length of the surviving parental daphnids in the tested concentration levels of 0.250 to 2.00 mg/L were determined to be in the range of 4.95 to 6.00 mm per daphnid, 5.98 mm per daphnid in the control group. A statistical significance in comparison to the control was determined in the concentration level of 2.00 mg/L (One Way Analysis of Variance, Dunnett’s method, p = 0.05).
The mean dry body weight was determined to be in the range of 0.78 to 1.25 mg per daphnid in the concentration levels of 0.250 to 2.00 mg/L and 1.24 mg per daphnid in the control
.

A summary of all test item related effects and the assessed effect levels for reproduction and adult mortality is given in Table 1.

Table 1:        Test Item Related Effects (NOEC, LOEC, EC10, EC50 and EC100)

(based on the nominal concentrations of 3-(Isodecyloxy)propylamine (CAS No. 30113-45-2))

Effects

3-(Isodecyloxy)propylamine (CAS No. 30113-45-2)

Nominal Concentration of the Test Item

[mg/L]

Control

0.250

0.500

1.00

2.00

4.00

Mean Number of Living Juveniles per

Producing Parent (Reproduction Rate ± SD)

177 ± 11

174 ± 4

196 ± 17

211 ± 141)

66 ± 471)

---

Coefficient of Variation of the Mean Number of Juveniles per Producing Parent [%]

    6

    2

    8

    7

712)

---

Percentage of Dead Juveniles Related to the Total Number of Juveniles [%]

    0

    0.457

    1.61

    0.941

  2.95

---

Mean Intrinsic Rates of Natural Increase

    0.51

    0.51

    0.52

    0.50

  0.363)

---

Appearance of First Brood [Mean Day]

    8.0

    8.0

    7.9

    8.1

11.2

---

Mean Number of Broods

    5.00

    5.00

    5.00

    5.00

  3.40

---

NOECReproduction

0.500 mg/L

LOECReproduction

1.00 mg/L

EC10 Reproduction

1.28 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L)

EC50 Reproduction

1.79 mg/L (95 % confidence limits: 1.00 – 2.00 mg/L)

Adult Mortality after 21 Days [%]

0

0

0

0

504)

1004)

Parent Animals: Mean Dry Weight [mg]

1.24

1.25

1.14

1.04

0.780

---

Parent Animals: Mean Body Length [mm]

5.98

5.90

6.00

5.80

4.951)

---

NOECAdult Mortality

1.00 mg/L

LOECAdult Mortality

2.00 mg/L

EC10 Adult Mortality

1.47 mg/L (95 % confidence limits: 1.44 – 1.49 mg/L)

EC50 Adult Mortality

2.00 mg/L (95 % confidence limits: 1.98 – 2.02 mg/L)

EC100 Adult Mortality

4.00 mg/L

SD = Standard deviation

1)    = Statistical significance (One Way Analysis of Variance, Dunnett’s method, p = 0.05)

2)    = Significant variation between the test replicates (Coefficient of variation 25 %)

3)    = Statistical significance (Kruskal-WallisOne Way Analysis of Variance on Ranks, Dunn’s method, p 0.05)

4)       = Significant adult mortality (> 20 %)


 

·       No males and ephippia (winter eggs) were observed in the control or in the test groups.

 

·   Water quality parametersas pH-value, dissolved oxygen, water hardness and temperature were within the acceptable limits.

·          In order to prove the validity of the test system and test conditions at the test facility, an acute immobilization test according to DIN 38412 L 11 is carried out with potassium dichromate as reference item once per month.
The EC50 of the reference item at
1.79 mg/L (95% confidence limits: 1.56 - 2.02 mg/L) after 24 hours is within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Description of key information

The 21d EC10 reproduction of 738 µg/L for daphnia is determined in a test according to OECD TG 211 (GLP, Reliability 1). The 21d EC50 for parental mortality was 1.05 mg/L in the same test. The effect concentrations are based on active ingredient.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.738 mg/L

Additional information

Results of two daphnia reproduction tests are available. One test is performed with 3 -(Isodecyloxy) propylamine acetate (CAS no. 28701 -67 -9). The other test is performed with 3 -(Isodecyloxy) propylamine (CAS no 30113 -45 -2). The results of the first study have been read-across to the registered substance. The substances have the same chemical stucture with the only difference being the presence of acetate. Acetate is not expected to influence the ecotoxicity of the substance and this is confirmed by the derived effect concentrations for the two substances. The lowest EC10 of the two tests (3 -(Isodecyloxy) propylamine acetate)

has been selected as key value for the chemical safety assessment.

The Daphnia magna Reproduction Test with natural river water (Semi-Static, 21 d) of 3-(Isodecyloxy)propylamine acetate was conducted according to OECD 211 (Noack, 2012). 10 test organisms were used per concentration and control. At test start they were 2 to 24 hours old. Concentrations and control were analytically verified at six sampling dates with LC-MS/MS. Recoveries were 96 – 116% of the nominal concentrations in the fresh media and 88 – 103 % in the 48h old media.

The EC10-value for the reduction of the reproductive output was estimated by linear interpolation (between the highest concentration level with increased reproductive output and the following concentration level which caused a reduction of the reproductive output of 25 %) to be 0.767 mg/L (95 % confidence limits: 0.500 – 1.00 mg/L) based on the nominal test material concentration. The 21d EC10 reproduction was 0.738 mg/L (C.I. 0.481 – 1.924 mg/L) converted to active ingredient. The EC50 parental mortality was 1.05 mg/L (a.i.) determined after 21 days of exposure. The latter value is used as worst-case acute EC50 for aquatic invertebrates in the hazard assessment in the absence of reliable acute data. The effects are expressed as nominal values because the tests were performed with river water as they are intended to be used in an evaluation of the environmental risks based on the Bulk approach.