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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May 2003 to 31 may 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with international guidelines (OECD 203) and GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP compliance statement
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
n/a
Analytical monitoring:
no
Details on sampling:
n/a
Vehicle:
no
Details on test solutions:
The behaviour of PR-4758 was examined according to the OECD 203 guideline.
Test solutions were prepared at concentrations of 0, 32, 56, 100 and 180mg/L by addition of the appropriate volume of the sample to dechlorinated mains tap water.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
Test Species: Rainbow Trout (Oncorhynchus mykiss)
Source: Horn Mill Trout Farm, Exton, UK
Date of Arrival at Laboratory: 29 Apr 2003
Accclimation Period: 29 Apr to 27 May 2003
Acclimation Conditions:
Temperature: 14.5 to 15.5 oC
Dissolved Oxygen: >87 % ASV
Photoperiod: 16 hours light and 8 hours dark

At the end of the test a sample of 10 trout were weighed and measured.
Mean length: 42.2 mm
Mean weight: 1.05 g
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
Approx. 286 mg/L calcium carbonate
Test temperature:
stock tank 15.0 deg C, test range 14.5 to 16.0 deg C, see Table 1
pH:
stock solution pH 8.1, test range 7.8 to 8.3, see Table 1
Dissolved oxygen:
stock tank 96% ASV, test rnage 92 to 100% ASV, see Table 1
Salinity:
n/a
Nominal and measured concentrations:
Nominal test concentrations were prepared as previously stated.
No analytical monitoring.
Details on test conditions:
TEST SYSTEM
Test Volume: 10 litres.

Number of replicates: 1 replicate at each control and test concentration.
Test Organisms: 7 trout were placed in each of the control and test vessels.
Replacement Regime: Semi-static, test solutions replaced every 24 hours, the remaining animals being transferred to freshly prepared test solutions.
Test Conditions: The test vessels were maintained at 15.0 ± 1.0 deg C
Water Quality Measurements: The pH (to 0.1), dissolved oxygen (to 1 % ASV), temperature (to 0.5 deg C) were measured. Water quality determinations for each test and control solution were carried out before and after each daily cahnge of test solutions.
Observation Frequency: Observations and records of mortalities were made after 24, 48, 72 and 96 hours.
Calculation and Expression of Results: Cumulative mortalities were calculated for each test concentration and control.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
110 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI = 79 - 161 mg/L
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
105 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI = 81 - 135 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
105 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI = 81 - 135 mg/L
Details on results:
96h LC50 = 105 mg/L
Results with reference substance (positive control):
n/a
Reported statistics and error estimates:
95% CI estimated using ToxCalc v5 were possible
Sublethal observations / clinical signs:

Cumulative percent mortality:

 Exposure period (hours)

                 Concentration (mg/L)

 Control

32

56

100

180

0

0

0

0

0

0

 24

0

0

14.3

0

0

 48   

0

0

14.3

14.3

100

 72

0

0

28.6

14.3

100

 96

0

0

28.6

14.3

100

Validity criteria fulfilled:
yes
Conclusions:
The 96 hour LC50 for PR-4758 was estimated to be 105 mg/L
The 96 hour NOEC was estimated as 32mg/L, and LOEC was 50 mg/L
Executive summary:

Substance: PR-4758

Chemex Reference: Sample: ECO040309; Study: ENV6431

Test Species: Rainbow Trout (Oncorhynchus mykiss)

Test Type: Acute toxicity: 96 hour LC50

Test Conditions: Semi-static test based on OECD 203: Fish Acute Toxicity Test guideline.

Test Period: 27 to 31 May 2003

 

Results:

Period of Exposure (hours)

LC50 (95% CI)

24

> 180 mg/L *

48

110 mg/L (79 - 161)

72

105 mg/L (81 - 135)

96

105 mg/L (81 - 135)

 * not possible to determine confidence limits

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 to 8 November 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with international guidelines (OSPAR) and in accordance with GLP. All relevant validity criteria were met.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Modified to marine conditions (OSPAR)
Qualifier:
according to guideline
Guideline:
other: OSPAR/PARCOM Protocols on Methods for the testing of chemicals used in the offshore industry 1995
Deviations:
no
GLP compliance:
yes
Remarks:
GLP compliance statement
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
n/a
Analytical monitoring:
no
Details on sampling:
n/a
Vehicle:
no
Details on test solutions:
The behaviour of PR-4758 in seawater was examined according to the method described in the Harmonised Offshore Chemical Notification Format (OSPAR 1995). A nominal 1000 mg/l solution was prepared in dilution water, shaken vigorously and allowed to stand for four hours.
A clear colourless solution was obtained. For each nominal concentration the required amount of homogenised sample was added to 10 litres of dilution water.
Definitive test solutions were prepared at concentrations of 0, 50, 100, 200, 400 and 800mg/L.
Test organisms (species):
other: Scophthalmus maximus
Details on test organisms:
TEST ORGANISM
Test Species: Turbot (Scopthalmus maximus)
Source: France Turbot, Boite Postale 305, 58330 Noirmoutiers, France
Date of Arrival at Laboratory: 04 Sept 2002
Accclimation Period: 04 Sept 2002 to 04 Nov 2002
Acclimation Conditions:
Temperature: 13.5 to 14.5 oC
Dissolved Oxygen: >95 % ASV
Photoperiod: 16 hours light and 8 hours dark

At the end of the test a sample of 10 turbot were weighed and measured.
Mean length: 49.0 mm
Mean weight: 3.16 g
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
mortality only
Hardness:
n/a
Test temperature:
13.5 - 15.0 deg C, see Table 1
pH:
stock solution pH 8.4 and see Table 1
Dissolved oxygen:
stock tank 99% ASV and see Table 1
Salinity:
stock tank 35 g/L sodium chloride and see Table 1
Nominal and measured concentrations:
The test substance nominal concentrations of 0 (control), 50, 100, 200, 400 and 800mg/L were prepared as "water accomodated fractions" according to OSPAR (1995) guidelines, although at all concentrations the substance was considered misceable. Therefore, the study was technically not testing WAFs, although the method was empoyed.
No analytical monitoring.
Details on test conditions:
TEST SYSTEM
Test Volume: 10 litres.

Number of replicates: 1 replicate at each control and test concentration.
Test Organisms: 7 turbot were placed in each of the control and test vessels.
Replacement Regime: Semi-static, test solutions replaced after 48 hours, the remaining animals being transferred to freshly prepared test solutions.
Test Conditions: The test vessels were maintained at 15.0 ± 1.5 deg C
Water Quality Measurements: The pH (to 0.1), dissolved oxygen (to 1 % ASV), temperature (to 0.5 deg C) and salinity were measured. Water quality determinations for each test and control solution were carried out immediately prior to initiating the test, after 24 hours, before and after the 48 hour change of test solutions, after 72 hours and at the end of the 96 hour exposure period.
Observation Frequency: Observations and records of mortalities were made after 24, 48, 72 and 96 hours.
Calculation and Expression of Results: Cumulative mortalities were calculated for each test concentration and control.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
283 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI = 197 to 407 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
141 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: n/a
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
86 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI = 68 to 109 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
71 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: n/a
Details on results:
96h LC50 = 71 mg/L
Results with reference substance (positive control):
n/a
Reported statistics and error estimates:
95% CI estimated using ToxCalc v5 were possible
Sublethal observations / clinical signs:

Cumulative percent mortality:

 Exposure period (hours)                  Concentration (mg/L)
 Control 50  100  200  400 800 
0 0 0 0 0 0 0
 24 0 0 0 14.3 85.7 100
 48    0 0 0 100 100 100
 72 0 0 71.4 100 100 100
 96 0 0 100 100 100 100
Validity criteria fulfilled:
yes
Conclusions:
The 96 hour LC50 for PR-4758 was found to be 71 mg/L
The 96 hour NOEC was 50mg/L, and LOEC was 100 mg/L
Executive summary:

Substance: PR-4758

Chemex Reference: Sample: ECO090209; Study: ENV6205

Test Species: Turbot (Scophthalmus maximus)

Test Type: Acute toxicity: 96 hour lethality test

Test Conditions: OSPAR/PARCOM Protocols on Methods for the Testing of Chemicals used in the Offshore Industry 1995.

OECD 203: Fish Acute Toxicity Test.

Test Period: 4 to 8 Nov 2002

Results:

Period of Exposure (hours)

LC50 (95% CI)

24

283 mg/L (197 - 407)

48

141 mg/L *

72

86 mg/L (68 - 109)

96

71 mg/L *

 * not possible to determine confidence limits

 

Description of key information

96 hour LC50 (rainbow Trout) = 105 mg/L; OECD 203; DJ Sacker (2003)

96hour LC50 (marine Turbot)  = 71 mg/L; OECD 203; WJ Craig (2002)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
105 mg/L

Marine water fish

Marine water fish
Dose descriptor:
LC50
Effect concentration:
71 mg/L

Additional information

A key study for both freshwater and marine compartments is available. Both studies were conducted in accordance with international guidelines and GLP.