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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached analogue justification provided in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
4.2 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Mortality of control: 0% at the end of the exposure
- Other adverse effects control: no adverse effects were observed in the control group
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 June - 11 July 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Remarks:
according to the GLP standard by the Japanese Ministry of Environment
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at the room temperature
- Stability under test conditions: verified at the beginning of and at the end of the exposure by IR, NMR and HPLC
Analytical monitoring:
yes
Details on sampling:
- Concentrations: All concentrations of test solution were analyzed at Day 0 (new), 2 (old), 8 (new), 10 (old), 15 (new), and 17 (old).
- Sampling method: directly sampled
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Age of parental stock: between 0 - 24 h
- Feeding during test: yes
- Food type: Chlorella vulugaris
- Amount: 0.1 - 0.2 mg C/d

ACCLIMATION
- Acclimation period: 4 weeks
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Chlorella vulugaris, 0.1 - 0.2 mg C/d
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
249 - 268 mg/L (as CaCO3)
Test temperature:
19.9 - 20.9 °C
pH:
6.7 - 9.9
Dissolved oxygen:
7.9 - 8.9 mg/L
Nominal and measured concentrations:
Nominal concentrations: control, 2.7, 4.8, 8.6, 15.4, 27.8, and 50.0 mg/L
Time-weighted mean measured concentrations:
Details on test conditions:
TEST SYSTEM
- Material, size: Glass, 100 mL
- Renewal rate of test solution: 3 times a week
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

OTHER TEST CONDITIONS
- Photoperiod: 16/8 (light/dark)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality of parental Daphnia, cumulative numbers of dead parental Daphnia, time to first brood production and mean cumulative numbers of juveniles produced per adult


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: an acute toxicity tes for 48 h was performed
- Test concentrations: not available in the report
- Results used to determine the conditions for the definitive study: EiC50 for 48 h was 58.4 mg/L
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
4.2 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Mortality of control: 0% at the end of the exposure
- Other adverse effects control: no adverse effects were observed in the control group
Reported statistics and error estimates:
EcoTox-Statics (Version 1.1) was used ti calculate EC50, LC50 and NOEC

ANALYTICAL RESULTS:

The pH of new solutions of higher concentrations was high and pH change during the exposure was cuased by the test substance. However, the test condition in terms of water temperature, dissolved oxygen concentration, pH and water hardness was appropriate for the test organism.

Table 1: pH during the 21 -d test

pH
Measured concentrations [mg/L] 0 d
new
2 d
old
8 d
new
10 d
old
15 d
new
17 d
old
control 7.2 7 7.2 6.7 7.4 7
2.2 7.3 7 7.6 6.8 7.6 7.3
4.2 7.6 7.1 7.9 6.9 7.9 7.3
7.7 8 7.1 8.4 6.9 8.2 7.4
14.7 8.5 7.2 9 7 8.7 7.5
26.9 9.1 7.3 9.4 7.1 9.2 7.6
49.2 9.8 7.5 9.9 7.2 9.8 7.8

Table 2: Time-weighted means of measured concentrations

Nominal concentration

(mg/L)

Time-weighted Mean

(mg/L)

Percent of nominal

(%)

Control

-

-

2.7

2.2

81.5

4.8

4.2

87.5

8.6

7.7

89.5

15.4

14.7

95.5

27.8

26.9

96.8

50.0

49.2

98.4

BIOLOGICAL RESULTS:

Time to first brood production was 8 - 11 days in the control group. Although it was 10 - 14 days in the 2.2 mg/L, no brood was observed at 26.9 and 49.2 mg/L.  

Table 3: Cumulative numbers of juveniles produced per adult alive for 21 days

Control

Measured concentration (mg/L)

2.2

4.2

7.7

14.7

26.9

49.2

Mean

86.5

75.4

76.4

17.8

2.8

0.0

0.0

S.D.

38.67

29.76

40.58

11.67

5.60

0.0

0.0

Inhibition rate (%)

 

12.8

11.7

79.4

96.8

100.0

100.0

Significant difference*1

 

 

 

**

**

**

**

*1: indicates a significant difference by Dunnet multiple comparison procedure, Two-sided test

**: indicates a significant difference (α = 0.001) from the control

Table 4: Mortality (%) of parental Daphnia

Measured concentration

(mg/L)

Days

1

2

4

7

14

21

Control

0

0

0

0

0

0

2.2

0

0

0

0

0

0

4.2

0

0

0

0

10

10

7.7

0

0

0

0

10

40

14.7

0

0

0

0

0

40

26.9

0

0

0

0

0

20

49.2

0

0

0

0

0

20

 

Other effect concentrations:

LC50 (21 d) > 49.2 mg/L (meas. TWA)

LOEC (21 d) = 7.7 mg/L (meas. TWA)

ErC50 (21 d) = 5.7 mg/L (meas. TWA)

VALIDITY CRITERIA:

Since the mortality of the parent animals (female Daphnia) did not exceed 20% at the end of the test and the mean number of living offspring produced per parent animal surviving at the end of the test was > 60, the test was considered to be valid.

Validity criteria fulfilled:
yes

Description of key information

NOEC (21 d) = 4.2 mg/L (meas. TWA) based on read across from CAS 109-89-7

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
4.2 mg/L

Additional information

Experimental data on the long term toxicity of Diethylammonium chloride (CAS 660-68-4) towards aquatic invertebrates are not available. Therefore appropriate read across data from the analogues substance N-ethylethanamine (CAS 109-89-7) were used for the environmental assessment.

The toxicity of the read across substance towards the test organism Daphnia magna was tested according to the OECD guideline 211 and GLP standards. Semi-static conditions were used for the test with a renewal rate of 3 times per week. The test organism was exposed for 21 d to nominal test item concentrations of 2.7, 4.8, 8.6, 15.4, 27.8, 50.0 mg/L (corresponding to measured: 2.2, 4.2, 7.7, 14.7, 26.9, and 49.2 mg/L) and a control. The presence of the tested substance in the testing medium, was analytically monitored by HPLC. The recoveries were between 81.5 and 98.4%. The test resulted in a NOEC (21 d) of 4.2 mg/L (meas., TWA).

Based on the results of the read across substance, similar effects are expected by the target substance Diethylammonium chloride (CAS 660-68-4) towards aquatic invertebrates.