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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not conducted in conformance to GLP, but study was conducted on the basis of EU Method C.2 (Acute Toxicity for Daphnia).
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
no
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia Magna
- Strain: Daphnia Magna Strausss
- Source: Bayer AG Leverkusen
- Age at study initiation (mean and range, SD): 0 - 24 hours

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: 20 ml
- Aeration: Not ventilated
- No. of vessels per concentration (replicates):2
- No. of vessels per control (replicates):2
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-Medium according to Elendt and BGA (1992)

OTHER TEST CONDITIONS
- oxygen (mg/l): 9
- pH range : 7.4 - 8.0
- temperature (°C): 21.1
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance to GLP and guidelines.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: M4 medium according to Elendt and at the Federal Health Office (BGA), Berlin Germany (1992)

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: Daphnia magna Strauss
- Source: BAYER AG Leverkusen, cloned at the Federal Health Office (BGA), Berlin Germany
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
19.8 °C
pH:
8.0
Dissolved oxygen:
8.8 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: 50 ml glass beakers, 20 ml test medium,
- Aeration: not ventilated
- No. of organisms per vessel: 10 daphnids (neonates)
- No. of vessels per concentration (replicates): 2



OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :


TEST CONCENTRATIONS: 100 mg/l
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

No effects were observed up to the highest concentration teste EC0 >= 100 mg/l nominal. Analytical verification confirmed 93% of nominal concentration at 48 hours.

Validity criteria fulfilled:
yes
Conclusions:
No effects observed up to the highest concentration tested.
EC0>=100 mg/L
EC50>100 mg/L.
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2b Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
The method uses newly hatched animals, 6 to 24 hours odl, which are incubated for 48 hours in a gradient of the test item. The animals were taken from Toxion's continuous culture of Daphnia magna. The culture originates from NIVA, Norway, and is on working days fed with approximately 50 - 75 ML green algae Pseudokirchneriella subspicata. A qualification test on the Daphnia magna culture was made on the 15th of May 2008 to assure the quality of the test animals. EC50 was 1.1 mg/L, which confirmed that the culture was suitable as a test organism according to OECD TG no. 202.
Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 +/- 25 mg CaCO3/L
Test temperature:
21 +/- 1 °C
pH:
Initial data (0 hours exposure): 7.96 to 7.98
Final data (48 hours exposure): 7.90 to 7.96
Dissolved oxygen:
Initial data (0 hours exposure): 102.3 to 102.8 %
Final data (48 hours exposure): 99.2 to 100.00 %
Nominal and measured concentrations:
Nominal test concentrations: 4000, 2000, 1000, 500, 250 and 125 mg/L
Details on test conditions:
light : dark rythm = 16 : 8
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1 590 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility

The EC50 was determined by graphic interpolation for the 48 hours of exposure to the test item Polyol R3530. The toxicity increased slightly during the time of exposure.

Table: Nominal NOEC- and EC50 -values (mg/L) determined after 24 hours and 48 hours exposure for the test item Polyol R3530. The EC50 -values were calculated by means of graphic interpolation. Probit-analysis was not carried out due to lack of data. The NOEC-value is defined as the highest tested concentration where the percent immobilisation is >= 10 %.

  24 h NOEC 48 h NOEC 24 h EC50 48 h EC50
Graphic interpolation 1000 1000 2460 1590
Validity criteria fulfilled:
yes
Conclusions:
Short-term toxicity to aquatic invertebrates (Daphnia magna) was determined according to OECD method no. 202 and gave a 48 hour-EC50 = 1590 mg/L. Further, a 48 hour-NOEC = 1000 mg/L is reported (Perstorp, 2010).

Description of key information

The 48 hr EC50 were reported as >100 mg/l.

Key value for chemical safety assessment

Additional information

Acute toxicity (48 hr) to aquatic invertebrates has been investigated with Daphnia magna in three independent tests, following procedures similar to or according to EU C.2 protocol or OECD 202. The 48 hr EC50 and EC0 were reported as >100 mg/l . Analytical verifiication performed in one study showed minimal loss of test material over the course of the exposure