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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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: P4
- Expiration date of the lot/batch: Feb 1999

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/vehicle: 30 g/l [in water]
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Daphnia magna
Details on test organisms:
- The organism used in this test system is the species Daphnia magna. The daphnids were bred in the laboratories of the Product Ecology under standardized conditions.

- Breeding: Cultures of Daphnia magna are held in glass vessels containing approx. 3.0 litre of reconstituted water at 18 - 22 °C. The water is renewed partially 3 times per week. The daphnids are fed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a Tetramine-extract in such quantities that the food will be consumed within 24 hours.

- Pre-treatment: 24 hours before the start of the exposure reproductive Daphnia were separated from the young daphnids by sieving all individuals through a 1000 micrometer sieve.

- For each test concentration 20 daphnids divided in two groups of 10 animals were used.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
249 mg/l CaCO3
Test temperature:
21.0 (at the start); 21.6 - 21.8 (at the end)
pH:
7.2 (at the start); 7.7 - 7.8 (at the end)
Dissolved oxygen:
99 % (at the start); 95 - 98 % (at the end)
Salinity:
No data
Nominal and measured concentrations:
Nominal concentrations: 9.4, 21, 45, 100 and 220 mg test article/l.
Measured concentration: 30.4 - 39.8 % of the nominal values.
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 ml glass beaker
- Type (delete if not applicable): open
- Aeration: No
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
- Biomass loading rate: 1 daphnia/ 10 ml

TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 0.8 mmol/l
- Ca/mg ratio: 4:1

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 12 hours light/12 hours dark.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 68.2 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: No immobilization and abnormal behaviour of the Daphnia was observed in the controls and in the test concentrations up to 17.6 mg/l (nominal 45 mg/l). Therefore, only the test concentrations of 17.6 / 31.2 and 68.2 mg/l (45 /100 and 220 mg/l nominal) were analysed and were taken for the evaluation of the EC-values. At 31.2 and 68.2 mg/l concentrations, the immobilization observed were 25 and 30 % respectively.
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
The EC50 values were calculated with the "Programm for the Computation of the ED50"; revised November, 1988 (V.1.2.), Ciba-Geigy AG; W.Seewald, Mathematical Applications / FO 5.31.
Validity criteria fulfilled:
yes
Conclusions:
FAT 20200/B is "not toxic" to Daphnia magna after 48 hours.
Executive summary:

The acute toxicity of FAT 20200/B to Daphnia magna was determined in a 48 hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202. The study was performed under Good Laboratory Practice (GLP) conditions in Switzerland. Due to the results of a pretest the nominal concentrations for the main test were selected as 9.4, 21, 45, 100 and 220 mg test article/I, a vehicle and a blank control without any additions. The test concentrations were prepared from a 0.22 g/l stock solution. Since the test substance was insoluble in water, most of the test substance in the stock solution settled down and built a sediment at the bottom of the flask. For the preparation of the test concentrations only the supernatant of the stock solution was taken (limit of the solubility). In the test concentration of 220 mg/l nominal a small sediment at the bottom of the test vessel was observed after 24 hours. Because of the low solubility of the test article in the test media, the actual test concentrations in the analysed test media were in the range of 30.4-39.8 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analysed concentrations of the test article measured at the beginning and at the end of the test. No immobilization and abnormal behaviour of the daphnids was observed in the controls and in the test concentrations up to 17.6 mg/l (nominal 45 mg/l). Therefore, only the test concentrations of 17.6, 31.2 and 68.2 mg/l (45, 100 and 220 mg/l nominal) were analysed and were taken for the evaluation of the EC-values. At 31.2 and 68.2 mg/l concentrations, the immobilization observed were 25 and 30 %, respectively.

In conclusion, the NOEC and EC0 value after 48 hours were determined to be 17.6 mg/l. The EC50 value after 48 hours could not be calculated, but was clearly higher than 68.2 mg/l.

Description of key information

FAT 20200/B has been tested up to the limit of solubility in the test-water in a study conducted according to OECD TG 202. No immobilization and abnormal behaviour of the daphnids was observed in the controls and in the test concentrations up to 17.6 mg/l (nominal 45 mg/l). At 31.2 and 68.2 mg/l concentrations, the immobilization observed were 25 and 30 % respectively. In conclusion, the NOEC and EC0 values after 48 hours were determined to be 17.6 mg/l. The EC50 value after 48 hours could not be calculated, but was clearly higher than 68.2 mg/l. FAT 21016/C was tested for acute toxicity on daphnids according to OECD-Test Guideline 202, Part I. Under the conditions used for the test, in the highest possible concentration (10.4 mg/L) no acute toxic effect of the test substance on daphnia was observed. Hence, it was concluded that the EC0 of FAT 21016/C is 10.4 mg/L, while the EC50 was assumed to be >10.4 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
68.2 mg/L

Additional information