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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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): XTJ 568
- Physical state: Clear colourless liquid
- Analytical purity: 97.8%
- Lot/batch No.: 8191-34
- Expiration date of the lot/batch: 01 January 2004
- Storage condition of test material: at room temperature in the dark
- Other: specific gravity: > 0.94 g/cm3
Analytical monitoring:
yes
Details on sampling:
Concentrations sampled:
- Range finding test: 10 mg/L
- Final (limit) test: control and 100 mg/L
Sampling: duplicate 10-mL samples from each sampled concentration
Sampling frequency:
- Range finding test: at t=0, t= 24, t = 96 h
- Final test: at t = 0, t = 96 h
Sampling storage: not applicable, immediate analysis
Vehicle:
no
Details on test solutions:
- Preparation of test solutions started with a stock solution of 100 mg/L in test medium, applying a 10-minute stirring period.
- Preparation of lower test concentrations through subsequent dilutions of the stock in test medium.
- Since pH of stock solution was 9.7 (outside optimum range for testing with fish (6.0-8.5)), pH was adjusted to 8.0 with 1 N HCl in the final test to exclude possible pH related effects.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Strain: no data
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation (length definition, mean, range and SD): range-finding test: 2.3 ± 0.2 cm; limit test: 2.1 ± 0.1 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.33 ± 0.09 g; limit test: 0.33 ± 0.04 g
- Characteristics: F1 from a single parent-pair bred in UV-treated water
- No feeding during test

HOLDING
- Acclimation period: at least 12 days after delivery
- Medium: ISO-medium, formulated using Milli-Ro water (tap-water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with the following composition:
CaCl2.2H2O: 293.8 mg/L
MgSO4.7H2O: 123.3 mg/L
NaHCO3: 64.8 mg/L
KCl: 5.8 mg/L
- Measurements: pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day
- Feeding: Daily with Trouvit
- Validity of batch: In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
250 mg CaCO3/L
Test temperature:
20.3-21.2°C
pH:
7.4-8.0
Dissolved oxygen:
6.5-8.7 mg/L
Salinity:
Not applicable
Nominal and measured concentrations:
Range finding test:
- Nominal: Control + 0.1-1.0-10-100 mg/L
- Measured (only 10 mg/L): 95-102% of nominal
Final test:
- Nominal: Control + 100 mg/L
- Measured: nd (control) and 103-108% of nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: 6.5-L glass vessels, fill-volume = 5 L
- Aeration: only prior to testing
- Static system
- Introduction of fish: within 15 minutes after preparation of test media
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.46 g fish/L at the start of testing
- Feeding: no feeding from 48 hours prior to the test and during the total test period

TEST MEDIUM / WATER PARAMETERS
- Test medium: same as during holding period (ISO, see above)
- Aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised.

OTHER TEST CONDITIONS
- Adjustment of pH: prior to testing adjusted to 8.0 using 1 N HCl; during testing no pH adjustment
- Photoperiod: 16L:8D

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality: at 3.5, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Range finding study: Control + 0.1, 1.0, 10, 100 mg/L
- Final (limit test): Control + 100 mg/L
- Results range finding study: LC50 > 100 mg/L (no mortality)
Reference substance (positive control):
yes
Remarks:
pentachlorophenol (PCP)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No mortality observed at the highest test concentration (100 mg/L) in the range finding study and the final (limit) test.
Results with reference substance (positive control):
96-h LC50 = 0.21 mg/L (95% CI = 0.19-0.27). Historical data are between 0.1 and 0.46 mg/L.
Reported statistics and error estimates:
No statistical method used since no mortality was observed at highest test concentration.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present test, the substance induced no mortality or any other clinical effects in juvenile carp (Cyprinus carpio) at 100 mg/L (i.e., the highest concentration tested). The 96-h LC50 is therefore above 100 mg/L. The study can be considered reliable (Klimisch 1).
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2011-02-21 - 2011-03-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): XTJ 568
- Chemical name: monoethyleneglycol, polybutyleneoxidediamine
- Molecular formula: C10H24N2O2
- Appearance: clear liquid
- Lot/batch No.: HSMX20110211-0184
- Receipt date: 2011-02-15
- Purity: 90%
- Storage condition of test material: in original container (plastic bottle with lid) at 4°C
Analytical monitoring:
yes
Details on sampling:
Samples for analysis of test substance concentration were taken (5 mL) from each test vessel at the start of testing, before and after the 48-h renewal of test medium, and at the end of testing.
Vehicle:
no
Details on test solutions:
- A 10 g/L stock solution was prepared in deionised water.
- pH of stock solution was adjusted to ca. 7.0 using 6M HCl.
- Test solutions used in test prepared by dilution of stock solution with test water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: ID: BR-MKT-100728
- Source: obtained from Shanghai Xiexing Aquarium
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): 2.5 +/- 0.2 cm
- Weight at study initiation (mean and range, SD): not reported
- Feeding during test: no

ACCLIMATION
- Acclimation period: held at laboratory for more than 14 days prior to testing
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: not reported
- Feeding frequency: daily (until 24 h before the test was started)
- Health during acclimation (any mortality observed): no diseases observed, no mortality within 7 days prior to testing
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
165 mg CaCO3/L
Test temperature:
22.0-24.1°C
pH:
7.26-7.93
Dissolved oxygen:
66.4-97.1% of ASV
Salinity:
not applicable
Nominal and measured concentrations:
Final (limit) test:
Nominal concentrations: control + 120 mg/L
Mean measured concentrations: < LOQ + 117.37 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 5-L glass tanks
- Type (delete if not applicable): open
- Aeration: yes, continuously
- Renewal rate of test solution (frequency/flow rate): frequency of renewal 48 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: ca. 1.0 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water, dechlorinated by activated carbon and sterilized by UV lamp
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily measurement of pH, dissolved oxygen and temperature

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12L:12D

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, recorded daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study: yes
- Test concentrations: control + 0.1-1.0-10-120 mg/L
- Results used to determine the conditions for the definitive study: yes (no mortalities observed)
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 117.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: no mortalities observed
Details on results:
No mortalities observed in the range finding test, nor in the final (limit) test.
Reported statistics and error estimates:
No statistics applicable.
Validity criteria fulfilled:
yes
Conclusions:
Based on the results of a range finding study, a limit test was conducted at 120 mg/L (nominal test substance concentration) to investigate mortality of zebra fish (Danio rerio) after 96 h of exposure. In the control nor at 120 mg/L were any mortalities observed. Based on mean measured concentrations of test substance, the 96-h LC50 was therefore > 117.37 mg/L.

Description of key information

Ir. L.M. Bouwman (2004) performed an acute toxicity study with the substance in Cyprinus carpio according to ISO Guideline 7346 -1, EU Method C.1 and OECD Guideline 203. An 96h-EC50 of > 100 mg/L for the endpoint mortality and a 96h-NOEC of 100 mg/L for other clinical effects (not further specified) were observed. A supporting study (Li et al., 2011) confirmed the findings.

Key value for chemical safety assessment

Additional information

Ir. L.M. Bouwman (2004) performed an acute toxicity study with the substance in Cyprinus carpio. Following concentrations were tested in range finding and final test.

Range finding test:

0 hours: 10 mg/L nominal -> analysed concentration range: 9.52 - 9.82 mg/L

24 hours: 10 mg/L nominal - > analysed concentration range: 9.56 - 9.68 mg/L

96 hours: 10 mg/L nominal -> analysed concentration range: 9.58 - 10.2 mg/L

Final test:

0 hours: 100 mg/L nominal -> analysed concentration range: 104-107 mg/L

96 hours: 100 mg/L nominal -> analysed concentration range: 103 - 108 mg/L

Under the conditions of the test, XTJ 568 induced no mortality or any other clinical effects in carp at 100 mg/L (Ir. L.M. Bouwman (2004)). The 96h-LC50 was above 100 mg/L.

In a supporting study (Li et al., 2011), the 96-h LC50 for zebra fish (Danio rerio) was concluded to be > 120 mg/L (nominal test concentration) as no mortalities were observed at this concentration level.