Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 March 2010 to 15 April 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the OECD Guideline and it is GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C20-22-alkyldimethyl
EC Number:
296-866-4
EC Name:
Amines, C20-22-alkyldimethyl
Cas Number:
93164-85-3
Molecular formula:
CnH2nN(CH3)2 n: from 18 to 22
IUPAC Name:
Amines, C20-22-alkyldimethyl
Details on test material:
-Physical state: clear colourless liquid
- Substance storage: at room temperature in the dark under nitrogen
- Stabilty under storage conditions: stable

Sampling and analysis

Analytical monitoring:
yes

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Crustacea, Cladocera)
- Source: In-house laboratory culture with a known history
- Maximum age of the cultures: 4 weeks
- Temperature of medium: 18-22ºC
- Feeding: Daily, a suspension of fresh water algae



Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

pH:
7.7
Dissolved oxygen:
9.3
Nominal and measured concentrations:
4.6, 10, 22, 46 and 100% of a WSF prepared at a loading rate of 100 mg/L.
control: test medium without test substance or other additives
Details on test conditions:
- Test vessels: 100mL, all-glass
- Number of daphnids: 20 per concentration
- Loading: 5 per vessel containing 80 mL of test solution
- Light: 16 hours photoperiod daily
- Feeding: not feeding
- Aeration: No aeration of the test solutions
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Dose descriptor:
NOEC
Effect conc.:
0.46 mg/L
Conc. based on:
test mat.
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 0.21 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.092 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

Acute immobilisation of daphnids after 24 and 48 hours in the final test

 %WSF / Actual (mg/L)  Vessel number  Number Daphnia exposed  Response  at 24 h  Response  at 48 h
     number  total %  number  total response
 control  A  5  0  0  0  0
   B  5  0    0  
   C  5  0    0  
   D  5  0    0  
0.1 / 0.003  A  5  0  0  0  0
   B  5  0    0  
 1.0 / 0.03  A  5  0  0  0  0
   B  5  0    0  
10 / 0.32  A  5  0  0  2  20
   5  0    0  
 100 / 3.2  A  5  3  55  5  100
  B  5  3    5  
 C  5  2    5  
   D  5  3    5  

Acute immobilisation of daphnids after 24 and 48 hours in the final test

 %WSF / Actual (mg/L)  Vessel number  Number Daphnia exposed  Response  at 24 h  Response  at 48 h
     number  total %  number  total response
 control  A  5  0  0  0  0
   B  5  0    0  
   C  5  0    0  
   D  5  0    0  
4.6 / n.a  A  5  0  0  0  0
   B  5  0    0  
   C  5  0    0  
   D  5  0    0  
22 / 0.03  A  5  0  0  0  0
   5  0    0  
   C  5  0    0  
   5  0    0  
46 / 0.08  A  5  0  0  0  0
   B  5  0    0  
   C  5  0    2  
   D  5  0    1  
100 / 0.21  A  0 (1)  0  5  100
   B  5  0    5  
   C  5  0    5  
   D*  5  0    6  

n.a not analysed

n.d not determined

* Inadvertently 6 organisms to this vessel

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study the substance induce ≤ 10% acute immobilisation of Daphnia magna at 0.03 mg/L after 48 hours of exposure. The 48h-EC50 was estimated to correspond to 0.092 mg/L based on average exposure concentrations.
Executive summary:

The study procedures described in this report were based on the OECD guideline 202 and the test methods of the Commission Regulation (EC) No 440/2008, Part C.2, 2008.Twenty daphnia per test group (5 per vessel, 4 vessels) were exposed to a control and a dilution series representing 4.6, 10, 22, 46 and 100% of a WSF prepared at a loading rate of 100 mg/L.Measured concentrations were 0.016, 0.046, 0.12 and 0.28 mg/L in the groups containing 10, 22, 46 and 100% of the WSF, respectively. The concentrations measured after 48 hours decreased by approximately 50% in the three highest groups, while the measured concnetration for the 10% WSF decreased below the LOD (<0.00017 mg/L).

The 48 -h EC50 was estimated to correspond to 0.092 mg/L based on average exposure concentrations.