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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
23-25 October 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Good quality study under GLP, however no chemical analyses.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Principles of method if other than guideline:
no chemical analyses
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information): no
Analytical monitoring:
no
Details on sampling:
no chemical analyses
Details on test solutions:
Direct dispersion in water. 1.0 g of test material was dispersed in 1 litre of diluent to give the stock solution of 1.0 g/L. 20 mL of this stock solution
were dispersed, in 2 litres of diluent to give the test concentration of 10 mg/L from which serial dilutions were made to give the test series.
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia Magna Straus
Source: Laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquée (I.R.CH.A), France
Culture: At 21 ºC in polypropylene vessels containing two litres of dechlorinated and aged tap-water. Cultures were fed daily with a suspension of
mixed algea (predominantly Chlorella spp.). Culture conditions ensure that reproduction is by parthenogenesis.
Selection: Gravid adults were isolated 24 hours prior to initiation of the test. Young daphnids produced overnight were used for testing
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
no
Hardness:
approximately 50 mg/L as CaCO3
Test temperature:
21.0 ºC
pH:
7.4-7.8
Dissolved oxygen:
7.8-8.4 mg O2/L
Salinity:
no data
Nominal and measured concentrations:
nominal concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 and 10 mg/L
Details on test conditions:
Test vessels: Glass jars each containing 200 mL test solution and covered to reduce evaporation.
Experimental design: 9 test concentrations plus 1 control each in duplicate. 20 animals per test concentration.
Method of initiation: Daphnia were placed in the test solutions after addition of the test substance.
Loading: 20 mL test solution per organism.
Photoperiod: 16 h light : 8 h dark.
Temperature: 21 ºC
Aeration: None.
Test concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 and 10 mg/L
Medium renewal: None.
Duration of exposure: 48 hours
Criteria of effect: Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.34 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Remarks on result:
other: 95%CL (0.286-0.37 mg/L)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.56 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95%CL (1.0-1.3 mg/L)
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
48 h EC50= 1.2 mg/L with 95% Confidence limits of 1.0-1.3 mg/L

Concentration

(mg/L)

Cumulative immobilized Daphnia (initial population : 10 per concentration)

24 hours

48 hours

R1

R2

Total

%

R1

R2

Total

%

Control

0

0

0

0

0

0

0

0

0.10

0

0

0

0

0

0

0

0

0.18

0

0

0

0

0

0

0

0

0.32

0

0

0

0

0

0

0

0

0.56

0

0

0

0

0

0

0

0

1.0

0

0

0

0

3

2

5

25

1.8

1

2

3

15

10

10

20

100

3.2

10

10

20

100

10

10

20

100

5.6

10

10

20

100

10

10

20

100

10

10

10

20

100

10

10

20

100

R1 and R2 = replicate 1 and 2

Validity criteria fulfilled:
yes
Conclusions:
Good quality study, however no chemical analyses therefore concentrations nominal. furtheremore the is no certifcate of analysis or detailed description of the substance.
Executive summary:

Test Conditions: Static test conditions according to OECD Guideline No. 202, Part 1 referenced as Method C.2 of Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Results

24 h EC50 = 2.2 mg/L (=0.63 mg a.i./L); 95% confident limits: 2.0 - 2.4 mg/L (=0.57 -0.69 mg a.i./L)

48 h EC50 = 1.2 mg/L (=0.34 mg a.i./L); 95% confident limits: 1.0 -1.3 mg/L (=0.286 -0.37 mg a.i./L)

ai= active ingredient

"No Observed Effect Concnetration" (NOEC) at 24 h = 1.0 mg/l (0.29 mg ai/l)

"No Observed Effect Concnetration" (NOEC) at 48 h = 0.56 mg/l (0.16 mg ai/l)

Description of key information

Two acute daphnia studies with Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts are available. The study lacks the quantification of the test substance during the test. The study from Sewell & Wetton (1992) resulted in a 48h EC50 for daphnia magna of 0.34 mg a.i./L based on nominal test concentrations. The study from Bazin et al., 1994 resulted in a 48h EC50 for daphnia magna of 7.6 mg a.i./L. As a worst-case the lowest value will be used for riks assessment and classification.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
0.34 mg/L

Additional information

Two acute daphnia studies with Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salt are available. Both studies lack similar to most other studies from this period the quantification of the test substance during the test. When these studies were performed no suitable sensitive analytical method was available for the quantification of this test substance.

The study from Sewell and Wetton (1992) resulted in a 48h EC50 for daphnia magna of 0.34 mg a.i./L based on nominal test concentrations.

The study from Bazin et al., 1994 which was performed according to EU Method C.2 (1992) resulted in 48h-EC50 value of 19 mg/L for the test item (7.6 mg/L for the active ingredient after correction for purity) based on nominal concentrations.