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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-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:
guideline study
Remarks:
GLP compliant study conducted in accordance with OECD 211 including analytical chemistry
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
New (days 0,7 and 14) and old (days 1, 8 and 15) samples taken on three occassions during the course of the test
Vehicle:
yes
Details on test solutions:
Test solutions were prepared by direct addition and dilution of the test substance into solvent dimethylformamide (DMF, 100 ul/L)
Test organisms (species):
Daphnia magna
Details on test organisms:
Test organisms were originally supplied by the National Institute for Environmental Studies, Environmental Protection Agency, on 18 July 1995.
Stock cultures (25 individuals) were maintained in 2 L Elendt M4 medium at 20+/- degrees C with a 16 hour light:8 hour dark lighting regime,
dissolved oxygen was >60% ASV. The cultures were fed chlorella vulgaris daily to ensure 0.2 mg organic carbon/per daphnia/per day.

Culture media was renewed three times per week and observed daily, juveniles were removed on a daily basis and discarded or used for testing
purposes. The breeding period for the stock culture that provided juveniles for testing was 26 May to 10 June 2004.

The juvenile daphnia used for testing were less than 24 hours old.

During testing ten individually housed juveniles per test concentration were maintained in 100 mL beakers containing 80 mL of test solution per
replicate. Observations wer conducted on a daily basis
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
NA
Hardness:
236 - 248 mg CaCo3/L
Test temperature:
19.9 - 20.2 degrees C
pH:
pH 7.5 - 8.4
Dissolved oxygen:
7.2 to 8.8 mg/L
Salinity:
NA
Nominal and measured concentrations:
Nominal test concentrations: 0.04, 0.105, 0.280, 0.750 and 2.0 mg/L
Time weighted average measured concentrations: 0.0421, 0.108, 0.287, 0.792 and 2.15 mg/L equivalent to 105, 103,103, 106 and 108% of nominal.Diluent and solvent control (100 ul/L, DMF) vessels also prepared.
Details on test conditions:
Test vessels: 100 mL
Test media volume per vessel: 80 mL
Test medium: Elendt M4 renewed daily
Replication: Test replicate vessels per concentration each containing one juvenile daphnia magna
Test vessels were covered with a teflon lid

The definitive concentration range was based on the results of an acute range finding test that reported a 48-hour EC50 value of 1.72 mg/L
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
1.3 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 0.792 to 2.15 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.39 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 0.350 to 0.437 mg/L
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.108 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.287 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
NA
Results with reference substance (positive control):
Potassium dichromate Average acute EC50=0.76 mg/L +/- 0.16 mg/L, n=12
Reported statistics and error estimates:
Statistical analysis and determination of EC50 value was conducted in accordance with OECD 211. Bartlett, ANOVA, Dunnett and Kruskal Wallis tests using Yukms-statlight software (Yukms-corp)

Biological results

Nominal concentration (mg/L)

TWA measured concentration (mg/L)

% nominal

% parental mortality

Time (days) to first brood production

Mean cumulative number of juveniles produced by day 21

Control

-

-

0

8

96

Solvent control

-

-

0

8

101

0.04

0.0421

105

0

8

106

0.105

0.108

103

0

8

101

0.280

0.287

103

0

8

76

0.750

0.792

106

0

14

7.2

2.0

2.15

108

100

-

-

Analytical results

Nominal concentration (mg/L) Measured concentrations (mg/L) Time weighted measured concentrations (mg/L)
0 new 1 old 7 new 8 old 14 new 15 old
Control <LOD <LOD <LOD <LOD <LOD <LOD <LOD
Solvent control <LOD <LOD <LOD <LOD <LOD <LOD <LOD
0.0 0.043 0.041 0.043 0.04 0.0438 0.042 0.042
0.105 0.11 0.11 0.11 0.1 0.11 0.11 0.11
0.28 0.28 0.28 0.29 0.28 0.30 0.29 0.29
0.75 0.82 0.78 0.78 0.76 0.82 0.80 0.79
2.00 2.16 2.14 * * * * 2.15
Validity criteria fulfilled:
yes
Conclusions:
In conclusion the test has been conducted and subsequently reported well. The OECD validity criteria were achieved and test concentrations were
maintained for the duration of the test.

EC50, NOEC and LOEC values for reproduction were all determined.
Executive summary:

A 21 -day Daphnia reproduction test with 4,4 -biphenol was conducted in accordance with GLP and OECD 211 test guideline. Ten individually housed Daphnia magna (<24 hours old) per concentration were exposed to nominal test concentrations of 0.04, 0.105, 0.280, 0.75 and 2.0 mg/L using a semi-static test design with test medium (Elendt M4) renewal every 24 hours.

The results of analytical sampling identified that test concentrations were maintated within 103 to 108% of the nominal concentration, time weighted average measured concentrations were determined to be 0.0421, 0.108, 0.387, 0.792 and 2.15 mg/L.

Daphnia were observed and juveniles removed/counted on a daily basis. At the end of the test the parental LC50 and reproductive EC50, NOEC and LOEC concentrations were determined to be 1.3, 0.390, 0.108 and 0.287 mg/L respectively based on time weighted mean measured concentrations (TWA).

The following results were reported:

Nominal concentration (mg/L)

TWA measured concentration (mg/L)

% nominal

% parental mortality

Time (days) to first brood production

Mean cumulative number of juveniles produced by day 21

Control

-

-

0

8

95.8

Solvent control

-

-

0

8

101

0.04

0.042

105

0

8

106

0.105

0.108

103

0

8

101

0.280

0.287

103

0

8

75.8

0.750

0.792

106

0

14

7.2

2.0

2.15

108

100

-

-

Description of key information

A daphnia reproduction test was conducted, the test provided a reproduction NOEC of 0.108 mg/L and an EC50 of 0.390 mg/L

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.108 mg/L

Additional information

A 21 -day Daphnia reproduction test with 4,4 -biphenol was conducted in accordance with GLP and OECD 211 test guideline. Ten individually housed Daphnia magna (<24 hours old) per concentration were exposed to nominal test concentrations of 0.04, 0.105, 0.28, 0.75 and 2.0 mg/L using a semi-static test design with test medium (Elendt M4) renewal every 24 hours.

The results of analytical sampling identified that test concentrations were maintained within 103 to 108% of the nominal concentration, time weighted average measured concentrations were determined to be 0.0421, 0.108, 0.387, 0.792 and 2.15 mg/L.

Daphnia were observed and juveniles removed/counted on a daily basis. At the end of the test the parental LC50 and reproductive EC50, NOEC and LOEC concentrations were determined to be 1.3, 0.390, 0.108 and 0.287 mg/L respectively based on measured concentrations (TWA).