Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
To produce the stock solution the test substance was weighted into water, treated in an ultrasonic bath for 1 hour and was then stirred on a magnetic stirrer for 24 hours.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM:
-Species: Daphnia magne STRAUS, parthenogenetic females
-Origin of species: cloned at the Federal Health Office (BGA) in Berlin
-Test animals: laboratory bred at Bayer AG Leverkusen
-Age of test animals: 0-24 hours
-Keeping water: M4-medium according to Elendt and BGA (1992)

ACCLIMATION:
Separation of test animals according to size before start of test:
-1st sieving on 1997-08-14 (at 2 pm)
-2nd sieving on 1997-08-15 (at 8 am)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
no data
Test temperature:
19.9-20.3 °C
pH:
7.8-8.0
Dissolved oxygen:
8.0-9.4 mg/L
Salinity:
n.a.
Conductivity:
no data
Nominal and measured concentrations:
Nominal concentrations: 2, 4, 8, 16, 32 mg/L
Details on test conditions:
TEST CONDITIONS:
-Test procedure:
-cylindical test vessel, diameter 4.0 cm, height 6.5 cm
-20 mL test medium
-not ventilated
-Method of administration: Stock solution (50 mg/L)
-Solubilizer or other auxiliaries: Ultrasonic bath, magnetic stirrer
-Control: M4-Medium according to Elendt and BGA (1992)
-Water for dilution: M4-Medium according to Elendt and BGA (1992)
-test parameters during the test:
-oxygen [mg/L]
-pH
-water temperature [°C]
-number of immobilie daphnids after 24 and 48 hours
-No. parallel solutions: 2
-Test volume: 20 mL
-No. daphnids per vessel: 10
Key result
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Remarks:
geometric mean EC0/EC100
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The values of the abiotic parameters (oxygen, pH and temperature) were determined from the total volume of the parallel solutions.
Validity criteria fulfilled:
yes
Remarks:
immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test; dissolved oxygen concentration remained above 3 mg/L throughout the exposure period
Conclusions:
The acute toxicity of the test item to invertebrates (Daphnia magna) was determined after 48 h of exposure and showed an EC0 of 4.0 mg/L and an EC100 of 16.0 mg/L. A geometric mean of EC0/EC100 was calculated to be 8.0 mg/L.
Executive summary:

The study was performed according to Method C.2 ‘Acute toxicity for Daphnia’ (1992), described in the Council Regulation (EC) No 92/69, which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilization Test'. Daphnids were exposed to the test item under static conditions for 48 h to a range of concentration (2, 4, 8, 16, 32 mg/L). Immobilization rates were recorded at 24-hour intervals. Additionally any abnormal behaviour or appearance of the Daphnia was reported every 24 hours. During the test a temperature range of 19.9 - 20.3 °C and a pH range of 7.8 -8.0 was maintained in the test vessels. Auxiliaries used to prepare the test media were an ultrasonic bath and a magnetic stirrer. No specific analysis was performed. EC0 = 4.0 mg/L and EC100 = 16.0 mg/L could be determined after 48 h of exposure. A geometric mean of EC0/EC100 was calculated to be 8.0 mg/L. The results are expressed in terms of nominal concentrations (at 24 and 48 h). This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute daphnia study.

Description of key information

The acute toxicity of the test item to invertebrates (Daphnia magna) was determined after 48 h of exposure and showed an EC0 of 4.0 mg/L and an EC100 of 16.0 mg/L. A geometric mean of EC0/EC100 was calculated to be 8.0 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
8 mg/L

Additional information

The study was performed according to Method C.2 ‘Acute toxicity for Daphnia’ (1992), described in the Council Regulation (EC) No 92/69, which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilization Test'. Daphnids were exposed to the test item under static conditions for 48 h to a range of concentration (2, 4, 8, 16, 32 mg/L). Immobilization rates were recorded at 24-hour intervals. Additionally any abnormal behaviour or appearance of the Daphnia was reported every 24 hours. During the test a temperature range of 19.9 - 20.3 °C and a pH range of 7.8 - 8.0 was maintained in the test vessels. Auxiliaries used to prepare the test media were an ultrasonic bath and a magnetic stirrer. No specific analysis was performed. EC0 = 4.0 mg/L and EC100 = 16.0 mg/L could be determined after 48 h of exposure. A geometric mean of EC0/EC100 was calculated to be 8.0 mg/L. The results are expressed in terms of nominal concentrations (at 24 and 48 h). This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute daphnia study.