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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:
key study
Study period:
10-12 September
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good quality study under GLP with certificate of analysis, however no chemical analyses. Therefore all concentrations in this report are nominal.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
no chemical analyses
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 a stock solution of 1.0 g/l. 200 ml of this stock solution
was dispersed in 2 litres of diluent to give a 100 mg/l stock solution from which serial dilutions were made to give the test series. The test material
was suspected to absorb to glassware and so saturation of the absorption sites was achieved by soaking the test vessels overnight prior to the
start of the test with the test solutions. At 0 hours the test vessels were emptied, rinsed with the solution to fresh test solution.

tested concnetrations: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/l.
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:
22ºC
pH:
7.3-7.4
Dissolved oxygen:
8.3-8.4 mg O2/L
Salinity:
no data
Nominal and measured concentrations:
nominal concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/l.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95%CL (6.4-10 mg/L)
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
48 h EC50= 8 mg/L with 95% Condifence Limits of 6.4-10 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

1.0

0

0

0

0

0

0

0

0

1.8

0

0

0

0

0

0

0

0

3.2

0

0

0

0

0

0

0

0

5.6

0

0

0

0

5

4

9

45

10

0

0

0

0

8

8

16

80

18

0

0

0

0

9

8

17

85

32

0

0

0

0

9

9

18

90

56

4

6

10

50

9

9

18

90

100

7

8

15

75

10

10

20

100

Validity criteria fulfilled:
yes
Conclusions:
Good quality study, however no chemical analyses therefore all concentrations nominal.
Executive summary:

Study Sponsor: Berol Nobel Nacka AB

Project Number: 116/95

Test Substance: Ampholak XO7

Test Spscies: Daphnia magna (Straus) tested in the 1st instar.

Test Type: Acute toxicity. 48 h EC50 (immobilisation).

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 = 62 mg/L (17 mg ai/l) 95 % confidence limits: 51 - 76 mg/L (15- 19 mg ai/l)

48 h EC50 = 8.0 mg/L (2.4 mg ai/l) 95 % confidence limits: 6.4 - 10 mg/L (1.9 - 3.0 mg ai/l)

ai= active ingredient

"No Observed Effect Concnetration" (NOEC) at 24 h = 32 mg/l ( 9.6 mg ai/l)

"No Observed Effect Concnetration" (NOEC) at 48 h = 3.2 mg/l ( 1.0 mg ai/l)

Description of key information

One acute daphnia study with Sodium oleylamphopolycarboxy glycinate is available. The study lacks the quantification of the test substance during the test. The study from Handley and Wetton (1992) resulted in a 48h EC50 for daphnia magna of 2.4 mg a.i./L based on nominal test concentrations.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
2.4 mg/L

Additional information

One acute daphnia study with Sodium oleylamphopolycarboxy glycinate is available. The study lacks similar to the two fish studies 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 Handley and Wetton (1992) resulted in a 48h EC50 for daphnia magna of 2.4 mg a.i./L based on nominal test concentrations.