Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Exposure solution temperatures were maintained at 20 ± 1°C during the definitive test versus the 21 to 25°C described in the OECD guideline 203.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 5 nominal concentrations plus a diluent water control were used (see below).
- Sampling method: A sample of approximately 120 mL was removed from each replicate exposure solution at time 0 (before fish added) and 96 hours during the definitive test. For the subsequent limit test, approximately 100 mL of each exposure solution at test start and end per dose were sent to the Sponsor.
- Sample storage conditions before analysis: Samples were refrigerated until submitted to the Sponsor for analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by adding the appropriate amount of test substance to the laboratory diluent water. Vigorous mixing with a power stirrer was used to dissolve or homogeneously distribute the test substance at nominal concentrations up to 10 mg/L. A stock solution for the limit study was prepared at 25 mg/L by dissolving/dispersing 5.00 g of test substance in 200 L of degassed laboratory diluent water. Vigorous mixing with a power stirrer for 22 hr was used in an ussuccessful attempt to completely dissolve the test substance in diluent water at approximately 20°C (Note: homogeneous distribution of the test substance during sampling was achieved). The dose solutions were prepared by adding 20 L of the 25 mg/L stock solution to the appropriate replicate test vessels.

- Controls: Diluent water

- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test substance was barely visible at the lowest concentration (nominally 0.6 mg/L). Undissolved test substance was observed to be present on the bottrom of each test vessel containing the remaining exposure concentrations used during the definitive test. The definitive test article dose concentrations apparently exceeded the aqueous solubility of the test substance with only a half hour of vigorous stirring at 20 ± 1°C.
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Strain: Not reported
- Source: Eco-Chem Testing Group Minnow Breeding Facility
- Age at study initiation (mean and range, SD): Juvenile fish from the same lot number, approximately the same age and size; age not reported
- Length at study initiation (length definition, mean, range and SD): Not reported; minnows were as uniform in size as possible
- Weight at study initiation (mean and range, SD): Not reported; biological loading within test vessels was kept below 1.0 g wet weight per liter of test solution. The average wet weight for 2 of the 12 sets of fish (10 fish/set) was determined at the start of the definitive test. These values were used as the average weight for each fish in the total test population. A separate average weight was determined for each replicate concentration series.
- Method of breeding: Not reported
- Feeding during test: Fish were not fed during the 24 hours before the test start or during the test
- Food type: Staple diet flake food
- Amount: Not reported
- Frequency: Not reported

ACCLIMATION
- Acclimation period: A minimum of 7 days at 20 ± 1°C before testing
- Acclimation conditions (same as test or not): The water source and temperature were the same as during the test
- Type and amount of food: Staple diet flake food; amount described as ample
- Feeding frequency: Not reported; food was withheld during the 24 hours before the test start
- Health during acclimation (any mortality observed): Not reported
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Temperature readings and observations for signs of mortality and stress were made at times 0, 6 (observations only during the limit test), 24, 48, 72, and 96 hours. Dissolved oxygen and pH were measured at times 0, 24, 48, 72, and 96 hours.
Hardness:
Mean historical control value for diluent water was 129.70 mg/L with a S.D. of 5.52 mg/L
Test temperature:
20 ± 1°C
pH:
The range of pH values were 8.0 and 8.4.
Dissolved oxygen:
The range of dissolved oxygen values were 6.2 and 9.2 mg/L.
Salinity:
Not reported
Nominal and measured concentrations:
Nominal concentrations in range-finding test: : 0, 0.5, 5, and 50 mg/L. Exposure solutions were not analyzed for the range-finding test
Nominal concentrations in definitive test : 0, 0.6, 1.2, 2.5, 5, and 10 mg/L
Measured concentrations in definitive test; mean values at 0 hr: <0.1, <0.1, <0.1, 0.13, 0.27, and 0.83 mg/L
Measured concentrations in definitive test; mean values at 96 hr: <0.1, 0.34, 0.81, 1.52, 2.64, and 4.21 mg/L
Nominal concentration in limit test: 25 mg/L
Measured concentration in limit test; mean value at 0 hr: 17.6 mg/L
Measured concentration in limit test; mean value at 96 hr: 19.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Pyrex® glass 30.5 cm cuboidal tank
- No. of organisms per vessel: Less than 10 g of fish per 20 L vessel.
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS (definitive study)
Temperature: 20 ± 1 ºC
pH: 8.0-8.4
Dissolved oxygen: 6.2 -9.2 mg/L
Dissolved organic carbon: 1.6-2.0 mg/L

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and stress measured at 0, 6 (observations only during the limit test), 24, 48, 72, and 96 hours
- Range finding study results: The nominal 96-hour LC50 was >50 mg/L and the acute No Observed Effect Concentration was 50 mg/L.
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 18.5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: The results of the limit test were deemed more reliable than those of the dose-response definitive test due to better solubility and recovery of the test substance. The endpoint reported is for the limit test.
Details on results:
- Behavioural abnormalities: None; all fish appeared normal
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: None of the control fish died
- Other adverse effects control: None; all fish appeared normal
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Undissolved test substance was observed on the bottom of each test vessel.
- Effect concentrations exceeding solubility of substance in test medium: The 96-hour mean exposure value of the highest dose studied approximated the aqueous solubility of the test substance.
Reported statistics and error estimates:
Results from the limit study were used to derive the LC50 value. Based on the lack of mortality, the LC50 was estimated to be >18.5 mg/L, the highest test concentration in the limit test.
Sublethal observations / clinical signs:

The 96-hour LC50was >18.5 mg/L and the 96-hour NOEC was 18.5 mg/L, based on mean measured test concentrations and lethal and sublethal effects. The results of the limit test were deemed more reliable than those of the dose-response definitive test due to better solubility and recovery of the test substance. The endpoint reported is for the limit test.

Validity criteria fulfilled:
yes
Conclusions:
96-h LC50 >18.5 mg/L
Executive summary:

The acute toxicity of the test substance to the fathead minnow (Pimephales promelas) was determined in a 96-hour, static, aquatic effects study. A static range-finding test was performed to establish the test article concentrations that would be appropriate for the subsequent definitive study.  An initial dose-response test was run using 0.6 to 10 mg/L test substance, however low recoveries of the test substance were observed. A subsequent limit test was also run to evaluate a higher dose level that more closely approximated the reported aqueous solubility of the test substance. Vigorous stirring for 22 hours resulted in initial recoveries >70% of nominal. Consequently, the results of the limit test are reported here. Tests were performed in replicates of two, 10 minnows/replicate. All minnows appeared normal at all concentrations at the end of the test. The 96-hour LC50 based on the results of the limit test was >18.5 mg/L. The 96-hour NOEC was 18.7 mg/L, based on mortality and sublethal effects.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 5 nominal concentrations plus a diluent water control were used (see below).
- Sampling method: A sample of approximately 120 mL was removed from each replicate exposure solution at time 0 (before fish added) and 96 hours during the definitive test. For the subsequent limit test, approximately 100 ml of each exposure solution at test start and end per dose were sent to the Sponsor.
- Sample storage conditions before analysis: Samples were refrigerated until submitted to the Sponsor for analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by adding the appropriate amount of test substance to the laboratory diluent water. Vigorous mixing with a power stirrer was used to dissolve or homogeneously distribute the test substance at nominal concentrations up to 10 mg/L. A stock solution for the limit study was prepared at 25 mg/L by dissolving/dispersing 5.00 g of test substance in 200 L of degassed laboratory diluent water. Vigorous mixing with a power stirrer for 22 hr was used in an ussuccessful attempt to completely dissolve the test substance in diluent water at approximately 20°C (Note: homogeneous distribution of the test substance during sampling was achieved). The dose solutions were prepared by adding 20 L of the 25 mg/L stock solution to the appropriate replicate test vessels.

- Controls: Diluent water

- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test substance was barely visible at the lowest concentration (nominally 0.6 mg/L). Undissolved test substance was observed to be present on the bottrom of each test vessel containing the remaining exposure concentrations used during the definitive test. The definitive test article dose concentrations apparently exceeded the aqueous solubility of the test substance with only a half hour of vigorous stirring at 20 ± 1°C.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Not reported
- Source: Eco-Chem Testing Group Minnow Breeding Facility
- Age at study initiation (mean and range, SD): Juvenile fish from the same lot number, approximately the same age and size; age not reported
- Length at study initiation (length definition, mean, range and SD): Not reported; minnows were as uniform in size as possible
- Weight at study initiation (mean and range, SD): Not reported; biological loading within test vessels was kept below 1.0 g wet weight per liter of test solution. The average wet weight for 2 of the 12 sets of fish (10 fish/set) was determined at the start of the definitive test. These values were used as the average weight for each fish in the total test population. A separate average weight was determined for each replicate concentration series.
- Method of breeding: Not reported
- Feeding during test: Fish were not fed during the 24 hours before the test start or during the test
- Food type: Staple diet flake food
- Amount: Not reported
- Frequency: Not reported

ACCLIMATION
- Acclimation period: A minimum of 7 days at 20 ± 1°C before testing
- Acclimation conditions (same as test or not): The water source and temperature are the same as during the test
- Type and amount of food: Staple diet flake food; amount not reported
- Feeding frequency: Not reported; food was withheld during the 24 hours before the test start
- Health during acclimation (any mortality observed): Not reported
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Temperature readings and observations for signs of mortality and stress were made at times 0, 6 (observations only during the limit test), 24, 48, 72, and 96 hours. Dissolved oxygen and pH were measured at times 0, 24, 48, 72, and 96 hours.
Hardness:
Historical mean value for diluent water was 129.70 mg/L with a S.D. of 5.52 mg/L
Test temperature:
12°C
pH:
The range of pH values were 7.7 and 8.3.
Dissolved oxygen:
The range of dissolved oxygen values were 10.8 and 7.6 mg/L.
Salinity:
Not reported
Nominal and measured concentrations:
Nominal concentrations in range-finding test: : 0, 0.5, 5, and 50 mg/L. Exposure solutions were not analyzed for the range-finding test
Nominal concentrations in definitive test : 0, 0.6, 1.2, 2.5, 5, and 10 mg/L
Measured concentrations in definitive test; mean values at 0 hr: <0.1, <0.1, <0.1, <0.1, <0.1, and 0.17 mg/L
Measured concentrations in definitive test; mean values at 96 hr: <0.1, 0.26, 0.44, 0.95, 1.59, and 2.48 mg/L
Nominal concentration in limit test: 25 mg/L
Measured concentration in limit test; mean value at 0 hr: 18.6 mg/L
Measured concentration in limit test; mean value at 96 hr: 18.8 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Pyrex® glass 30.5 cm cuboidal tank
- No. of organisms per vessel: Less than 10 g of fish per 20 L vessel
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS (definitive study)
Temperature: 12ºC
pH: 7.7-8.3
Dissolved oxygen: 7.6-10.8 mg/L
Dissolved organic carbon: 1.6-1.8 mg/L

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and stress measured at 0, 6 (observations only during the limit test), 24, 48, 72, and 96 hours
- Range finding study results: The nominal 96-hour LC50 was >50 mg/L and the acute No Observed Effect Concentration was 50 mg/L.
Duration:
96 h
Dose descriptor:
other: LC50 (limit test)
Effect conc.:
> 18.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: The results of the limit test were deemed more reliable than those of the dose-response definitive test due to better solubility and recovery of the test substance. The endpoint reported is for the limit test.
Duration:
96 h
Dose descriptor:
other: LC50 (dose response test)
Effect conc.:
> 1.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Details on results:
- Behavioural abnormalities: None; all surviving fish appeared normal
- Observations on body length and weight: Not reported
- Other biological observations: One fish in the 0.6 mg/L group in test series A was found dead at 96 hours
- Mortality of control: One of the control fish in test series B died at 96 hours
- Other adverse effects control: None; all surviving fish appeared normal
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Undissolved test substance was observed on the bottom of each test vessel.
- Effect concentrations exceeding solubility of substance in test medium: The 96-hour mean exposure value of the highest dose studied approximated the aqueous solubility of the test substance. The results of the dose-response definitive test were not used to derive and LC50. Recovery of the test substance at the start of the test was poor and undissolved test substance was apparent in all but the lowest test concentration. Recovery in the limit test exceeded the validity criterion and therefore the results of this test were used to derive the 96-hour LC50.
Reported statistics and error estimates:
Results from the limit study were used to derive the LC50 value. Based on the lack of mortality, the LC50 was estimated to be >18.7 mg/L, the highest test concentration in the limit test.
Sublethal observations / clinical signs:

The 96-hour LC50was >18.7 mg/L and the 96-hour NOEC was 18.7 mg/L, based on mean measured test concentrations and lethal and sublethal effects. The results of the limit test were deemed more reliable than those of the dose-response definitive test due to better solubility and recovery of the test substance. The endpoint reported is for the limit test.

Validity criteria fulfilled:
yes
Conclusions:
96-h LC50 >18.7 mg/L
Executive summary:

The acute toxicity of the test substance to the rainbow trout (Salmo gairdneri) was determined in a 96-hour, static, aquatic effects study. A static range-finding test was performed to establish the test article concentrations that would be appropriate for the subsequent definitive study. A limit test was also done to evaluate a higher dose level that more closely approximated the aqueous solubility of the test substance. Vigorous stirring for a half hour alone was not sufficient to completely dissolve the test substance added to each test vessel. The test substance continued to dissolve slowly over the 96-hour exposure period. Recovery of the test substance in the limit test was good throughout the test, presumably due to more vigorous stirring for 72 hours and therefore the results of the limit test were used to determine the LC50. Tests were performed in replicates of two, 10 trout/replicate. There were no mortalities at any time in both controls and the test substance treatments in the limit test. The 96-hour LC50was estimated to be >18.7 mg/L. The 96-hour NOEC was determined to be 18.7 mg/L, based on mean measured test concentrations and mortality and sublethal effects.

Description of key information

96-hour LC50 >18.5 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
18.5 mg/L

Additional information