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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted to international test guideline (OECD 203) with chemical analysis by HPLC
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Biphenyl-4,4’-diol / CAS 92-88-6
Analytical monitoring:
yes
Details on sampling:
Test medium sampled at 0 hours (new) and 24 hours (old)
Vehicle:
yes
Details on test solutions:
Test solutions prepared by dissolution of weighed quantity of test substance in solvent, dimethylformamide (DMF) followed by dilution (100 ul/L) in treated water to provide final test concentrations
Test organisms (species):
Oryzias latipes
Details on test organisms:
Length: 1.55 cm (1.5 to 1.75 cm) n = 10
Weight: 0.047 g (0.030 to 0.090 g) n = 10
Loading 1 g/L
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
NA
Hardness:
Not reported
Test temperature:
Temp: 23.7 to 24.9°C
pH:
pH : 7.3 to 7.9
Dissolved oxygen:
Dissolved oxygen: 6.7 to 8.3
Salinity:
NA
Nominal and measured concentrations:
Nominal concentrations: 3.0, 5.3, 9.5, 17 and 30 mg/L (spacing factor 1.8)
Measured concentrations: (0 hours): 3.05, 5.57, 9.56, 17.1 and 30.7 mg/L
Measured concentrations: (24 hours): 3.02, 5.60, 9.61, 16.9 and 29.7 mg/L.
Mean measured concentrations: 3.03, 5.58, 9.58, 17 and 30.2 mg/L (0-24 hours)
Details on test conditions:
Diluent and solvent (DMF) controls
1 replicate per concentration, 5.0 L and 10 fish per vessel
16 hour light:8 hour dark

1000 Lux, 24 ± 1°C
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
12.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: (9.58 to 17.0 mg/L)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
9.58 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
During the conduct of the test there was no mortality in the solvent control, 3.0 or 9.5 mg/L groups, 10 % mortality occured in the control and 5.3 mg/L. At concentrations of 17 and 30 mg/L 100% mortality was evident.
Results with reference substance (positive control):
NA
Reported statistics and error estimates:
Binomial

Observations of mortality

Nominal (mg/L)

Mean measured (mg/L)

% mortality

24 hours

48 hours

72 hours

96 hours

Control

-

0

0

0

10

S. Control

-

0

0

0

0

3.0

3.03

0

0

0

0

5.3

5.58

0

0

0

10

9.5

9.58

0

0

0

0

17

17.0

50

100

100

100

30

30.2

100

100

100

100

Analytical results

Nominal concentration (mg/L) Measured concentrations (mg/L) Geometric mean measured concentrations (mg/L)
0 hours 24 hours
Control <LOD <LOD <LOD
Solvent control <LOD <LOD <LOD
3.0 3.05 3.02 3.03
5.3 5.57 5.60 5.58
9.5 9.56 9.61 9.58
17 17.1 16.9 17
30 30.7 29.7 30.2
Validity criteria fulfilled:
yes
Conclusions:
At the end of the test the 96 hour LC50 was calculated to be 12.8 mg/L (CI 95% 9.58 to 17 mg/L)
The NOEC based on mortality was 9.58 mg/L
The NOEC based on sub-lethal effects was 3.03 mg/L
Executive summary:

A GLP compliant 96 hour semi-static acute toxicity Oryzias latipes (medaka) was performed in accordance with OECD 203 (1992) to assess the toxicity of 4,4,biphenol. Nominal test concentrations were : 3.0, 5.3, 9.5, 17 and 30 mg/L (spacing factor 1.8) a diluent and solvent (DMF) control were also included and measured concentrations were determined.

The geometric mean measured concentrations were 3.03, 5.58, 9.58, 17 and 30.2 mg/L. 

At the end of the test the 96 hour LC50was calculated to be 12.8 mg/L (CI 95% 9.58 to 17 mg/L) based on geometric mean measured concentrations.

The NOEC based on mortality was 9.58 mg/L The NOEC based on sub-lethal effects was 3.03 mg/L (based on geometric mean measured concentrations).

Description of key information

Semi-static GLP compliant acute toxicity test with Oryzias latipes (medaka) exposed to 4,4-biphenol, conducted in accordance with OECD 203 (1992) and supporting chemical analysis.

Key value for chemical safety assessment

LC50 for freshwater fish:
12.8 mg/L

Additional information

A GLP compliant 96 hour semi-static acute toxicity test with Oryzias latipes (medaka) was performed in accordance with OECD 203 (1992) to assess the toxicity of biphenyl-4,4'-diol. Nominal test concentrations were : 3.0, 5.3, 9.5, 17 and 30 mg/L (spacing factor 1.8). A diluent and solvent (DMF) control were also included and measured concentrations were determined.

Following analytical determination the geometric mean measured concentrations were 3.03, 5.58, 9.58, 17 and 30.2 mg/L. The results below are based on geometric mean measured concentrations.

At the end of the test the 96 hour LC50was calculated to be 12.8 mg/L (CI 95% 9.58 to 17 mg/L).

The NOEC based on mortality was 9.58 mg/L. The NOEC based on sub-lethal effects was 3.03 mg/L.