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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Feb - 31 Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity Test)
Version / remarks:
Draft version 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 72-4 (Fish Early Life-Stage and Aquatic Invertebrate Life-Cycle Studies)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Control, 0.63, 1.25, 2.50, 5.00 and 10.0 mg a.i./L nominal
- Sampling method: Samples of test solutions, from all levels, were taken from two alternating replicate test chambers on Days 0, 7, 14, 21, 28 and 35. The test system was designed with one splitter cup delivering to replicates A, B, C and D at each concentration. On each day of analysis, replicates A and B or replicates C and D were sampled. The samples for analysis were collected from mid-depth in each aquarium. Measured 100 mL of each sample into separate 250-mL extraction funnels, pipetted 1 mL of glacial acetic acid into each funnel, swirled to mix. Test solutions from seven sampling intervals were received and analyzed between February 25, 2004 (Day 0) and March 31, 2004 (Day 35).
- Sample storage conditions before analysis: Samples were analyzed on the same day.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 1.55 g a.i./L stock solution was prepared by adding approximately 32.5 g of the test item to a 20-L quantity of dilution water in a 38-L tank. The contents were stirred for 22 to 45 hours. The stock solution was used to dose the test aquaria with the test item via a modified proportional diluter system.
- Controls: dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):no vehicle was used
- Differential loading: no

Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: fathead minnow
- Source: The eggs were received from Osage Catfisheries, Inc. in Osage Beach, MO on September 9, 2003 but propagated at test facility
- Age at study initiation (mean and range, SD): All eggs used in the test were < 24 hours old and between the 2-cell stage and gastrulation, as determined by careful observation under a stereomicroscope.
- Method of breeding: This lot was maintained in the laboratory under flow-through conditions in soft blended water. The breeding culture consisted of aquarium containing 2 male and 5 female fathead minnows, and three spawning substrates.
- Feeding during test: Feeding began on Day 4
- Food type: Live brine shrimp (Artemia salina) nauplii
- Amount: 0.5 - 5.0 ml per feeding until approximately 24 hours prior to study termination.
- Frequency: Food was equally added to the aquaria at least once daily on weekends and three times daily on weekdays

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Method of collection of fertilised eggs and subsequent handling: Eggs were removed from the substrates daily and were collected for the test on the morning of test initiation. On that day, the collected eggs were sorted and any eggs appearing to be nonviable were not used in the test.

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
35 d
Hardness:
48 - 62 mg/L (control and test item concentrations)
Test temperature:
24.6 - 25.8 °C (Mean 24.9 °C)
pH:
7.9 - 8.2 (control)
7.4 - 8.0 (test item concentrations)
Dissolved oxygen:
6.4 - 8.2 mg/L (control)
5.8 - 8.2 mg/L (test item concentrations)
Conductivity:
131 - 168 µmhos/cm (control and test item concentrations)
Nominal and measured concentrations:
control, 0.63, 1.25, 2.50, 5.00 and 10.0 mg a.i./L (nominal)
Control, 0.58, 1.10, 2.37, 5.07 and 10.6 mg a.i./L (mean measured concentrations)
Details on test conditions:
TEST SYSTEM
- Egg cups: Egg cups were positioned on an oscillating rocker arm assembly to facilitate the circulation of test solution in the egg cups.
- Test vessel: glass vessels
- Size of vessel: 8.4 L aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass aquaria, 7 liters of test solution with a water depth of 25.2 cm; aquaria were immersed in a circulating water bath to maintain; temperature at 25 +/- 1 °C.
- Aeration: No
- No. of fertilized eggs/embryos per replicate: 35 eggs at initiation, thinned to 20 alevin after hatching phase
- Egg distribution: 5 Eggs were transferred into an incubation egg cup containing dilution water. The dilution water was held in the egg cup by a petri dish surrounding the lower portion of the egg cup. This process was repeated until each cup contained 35 embryos. They were randomly placed into the test chambers. All incubation cups were observed daily for egg mortality. Egg mortality, as discerned by a distinct change in coloration and by microscopic observations, was recorded and the dead eggs discarded.
- Type of flow-through (e.g. peristaltic or proportional diluter): Flow through exposure was performed with a modified Mount-Brungs proportional diluter system and a syringe pump for the intermittent introduction of the test solution. The diluter had been modified to change the timing of the injection of the test material to the toxicant mixing chamber so as to maximize the mixing. Test material was delivered to the mixing chamber with a Hamiltonseries 500-syringe pump.
- Renewal rate of test solution (frequency/flow rate): The single syringe delivered a 25-ml injection of stock solution to approximately 3.85 L dilution water within the toxicant mixing chamber (the nominal concentration in the toxicant mixing chamber was 10 mg a.i./L). The appropriate volume of dilution water and toxicant solution was blended and delivered to the flow splitting cells to create the 0.63, 1.25, 2.5, 5.0 and 10.0 mg a.i./L test solutions. The accuracy (±10%) of the test solution delivery system was checked prior to test initiation. The diluter system operation was mechanically monitored 24 hours per day for the number of cycles. The test vessel turnover rate was approximately 7 turnovers per day.
- No. of organisms per vessel: 35
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): no vehicle was used
- Biomass loading rate: The biomass loading factor estimate for 20 fish in an aquarium was 0.1 g/L during a 24-hour period.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Multimedia filter and ultraviolet sterilizer spring water blended with reverse osmosis (RO) water designed to produce soft (40 to 60 mg/L as CaCO3) water.
- Total organic carbon: 2.1 mg/L (Spring) and <0.50 mg/L (RO)
- Particulate matter: 5 mg/L
- Metals: Calcium: 160000 µg/L (Spring) and < 1000 µg/L (RO); Magnesium: 9900 (Spring) and < 500 µg/L (RO);Potassium: 1900 µg/L (Spring) and < 500 µg/L (RO); Sodium: 120000 µg/L (Spring) and 1400 µg/L (RO); Others: < 0.2 - < 100 µg/L (Spring) and < 0.2 - < 100 µg/L (RO)
- Pesticides: Organophosphate: < 0.10 - <0.5 mg/L (Spring and RO); OP/Nitro: <0.10 µg/L (Spring and RO)
- Chlorine: < 0.004 mg/L
- Alkalinity: 45 - 60 mg/L (control), 44 - 57 mg/L (test item concentration)
- Ca/mg ratio: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: Blended water is screened weekly for residual chlorine using a Wallace & Tiernan Amperometric Titrator. The automated system constantly monitors the city water after dechlorination to ensure that the level of residual chlorine is less than 3 μg/L (ppb).

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hours light and 8-hours dark with a 30-minute transition period of lower light
- Light intensity: 60 to 74 foot-candles (646 to 797 lux) and averaged 68 foot-candles (731 lux)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Egg Observations: Daily for mortality (nonviable eggs removed) and hatching
Hatching Phase: When at least 90% of all viable control eggs had hatched, observations were made, and the alevin were impartially thinned to 20 per replicate by releasing them from the egg cup to the test vessel in which the egg cup had been suspended. By Day 5 at least 90% of all viable eggs has hatched.

POST-HATCH DETAILS
- Begin of post-hatch period: Day 6
- Post Hatch Phase Observations: Observations of abnormal behavior, abnormal physical changes and mortality were recorded daily by visually inspecting the organisms in each growth chamber. Dead fry were noted, removed and discarded.
- Length Measurements: At termination of biological phase the surving fish were sacrificed. Standard lengths was determined for each individual fish and were determined by measuring from the tip of the snout to the tip of the caudal peduncle using a millimeter scale.
- Wet Weight Measurements: The wet weight of control fish was recorded for biomass loading estimates. Fish were blotted on paper towels to remove excess moisture prior to weighing.
- Dry Weight Measurements: Fish were placed in a drying oven (Baxter Drying Oven, Model DX-41) set to approximately 60 °C for approximately 48 hours. The dried fish were then cooled down in a dessicator for approximately 72 hours, and individually weighed using a Mettler Model AE 163 balance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0

RANGE-FINDING STUDY: No range-finding test was performed.
Reference substance (positive control):
no
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
>= 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
larval development
Remarks:
alevin survival (Day 5)
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
> 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
larval development
Remarks:
alevin survival (Day 5)
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
2.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
larval development
Remarks:
fry survival (Day 35)
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
5.07 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
larval development
Remarks:
fry survival (Day 35)
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
>= 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
number hatched
Remarks:
percent hatch
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
> 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
number hatched
Remarks:
percent hatch
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
>= 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
time to hatch
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
> 10.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
time to hatch
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
0.58 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks:
length and weight
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
1.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks:
length and weight
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
2.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
morphology
Remarks:
Morphological and Behavioral effects
Duration:
35 d
Dose descriptor:
LOEC
Effect conc.:
5.07 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
morphology
Remarks:
morphological and behavioral effects
Details on results:
- Observed effects at each concentration for each observation time: see Table 2-4 in "Any other information on results incl. tables"
- Cumulative mortality at each concentration and for each recommended observation time if possible: statistical significant mortality was determined at 5.07 mg a.i./Land 10.6 mg a.i./L
- Mortality in the controls: no statistical significant (4 dead fish in total for all 4 replicates)
- Behavioural observation of the fish: Observation for morphological and behavioral effects for treatment groups were consistent with the control group with the exception of the highest two test concentrations (5.07 and 10.6 mg a.i./L). For these two groups, morphological and behavioral effects were notably greater than in the control group. Further, mortality was significant in both of these concentrations.
- Effect concentrations exceeding solubility of substance in test medium: No undissolved compound was observed in the test system throughout the exposure period.

Results with reference substance (positive control):
No reference substance was tested.
Reported statistics and error estimates:
Chi-square test to test for normality and Bartlett’s test for homogeneity of variance. All data were analyzed without transformations when the normality and homogeneity of variance tests were passed. One way Analysis of Variance (ANOVA) was used to determine if there was a significant difference between the treatment groups and the control. If the results of the ANOVA showed significant differences (% = 0.05) then a Dunnett’s one-tailed multiple means comparison test and the William’s test (if appropriate) were conducted to identify which treatment group(s) were significantly different from the control groups. The results were used to determine the No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC). For the data that did not pass the test for normality or homogeneity of variance, Steel’s Many- One Rank test or Wilcoxon’s Rank Sum Test with Bonferroni adjustment was performed. Statistical analyses were conducted using PC based computer programs (SAS ver. 8.0 or greater and/or TOXSTAT ver. 3.3).

Behavioral and Morphological Observations:

For the 0.58, 1.10 and 2.37 mg a.i./L test concentrations, the number of fish noted with sublethal effects were few and infrequent.No dose response in relation to the controls was exhibited at these concentrations.Sublethal effects were noted at a greater frequency at the 5.07 and 10.6 mg a.i./L test concentrations. At the 5.07 mg a.i./L level, approximately 19 fish were noted to display sublethals effects to include: pale, darkened coloration, bent spine, swimming erratically, fish at the water surface and fish resting on the bottom of the test vessel. For the 10.6 mg a.i./L test level, observations included: pale, loss of equilibrium and fish on the bottom of the test vessel. These numbers were not quantified since the mortality was high at this concentration.

 

Time to hatch

Mean hatch for Day 3 ranged from 0.0 to 14.3%. For Day 4 the mean hatch ranged from 85.0 to 95.7%. By Day 5, at least 90% of all viable eggs at all test levels had hatched resulting in a mean range of 89.3 to 96.4 % hatch.

 

Percent Hatch

Percent hatch was evaluated on study day 5. The percent hatch was determined as follows:

Percent hatch on Day 5 = (alevin/total # eggs on Day 0) x 100 The mean percent hatch on study day 5 ranged from 89.3 percent to 96.4 percent in the controls and treatment groups (Table 9, Appendix 1). Statistical analysis of the data passed the criteria for normality and homogeneity of variance. Therefore, parametric analyses were conducted on this endpoint. No statistically significant difference between the controls and treatment groups was detected.

 

Alevin and fry survival

Study day 5 alevin survivorship analysis was based on the number of eggs at the experimental start. Study day 35 fry survivorship analyses were based on the number of fry in the test system after thinning. Mean alevin survival on study day 5 ranged from 89.3 to 96.4%. Mean fry survival on Day 35 ranged from 12.5 to 95.0%.

 

Growth

Growth effects were determined based on fish lengths and dry weights. Mean fish length ranged from 11.2 to 23.9 mm while mean fish dry weight ranged from 4.0 to 65.3 mg. The assumptions of normality and homogeneity of variance were met for all growth data.

Table 1: Measured Concentrations of Test Item During the Fathead Minnow Early Life Stage Toxicity Test

Nominal concentration (mg/L)

Measured Concentration (mg a.i./L)

Day 0

Day 7

Day 14

Day 21

Day 22 1

Day 22 2

Day 28

Day 35

Mean

Standard Deviation

Percent of Nominal

Control A

<0.06

---

<0.06

---

<0.06

<0.06

<0.06

---

NA

NA

NA

Control B

<0.06

---

<0.06

---

---

---

<0.06

---

 

 

 

Control C

---

<0.06

---

<0.06

---

---

---

<0.06

 

 

 

Control D

---

<0.06

---

<0.06

---

---

---

<0.06

 

 

 

0.63 A

0.60

---

0.58

---

0.55

0.57

0.59

---

0.58

0.02

91.6

0.63 B

0.61

---

0.59

---

---

---

0.59

---

 

 

 

0.63 C

---

0.59

---

0.58

---

---

---

0.56

 

 

 

0.63 D

---

0.59

---

0.54

---

---

---

0.54

 

 

 

1.25 A

1.14

---

1.12

---

1.02

1.09

1.04

---

1.10

0.04

87.9

1.25 B

1.17

---

1.13

---

---

---

1.10

---

 

 

 

1.25 C

---

1.12

---

1.07

---

---

---

1.10

 

 

 

1.25 D

---

1.09

---

1.10

---

---

---

1.09

 

 

 

2.50 A

2.39

---

2.38

---

2.23

2.37

2.40

---

2.37

0.10

94.7

2.50 B

2.47

---

2.22

---

---

---

2.34

---

 

 

 

2.50 C

---

2.48

---

2.24

---

---

---

2.53

 

 

 

2.50 D

---

2.45

---

2.33

---

---

---

2.30

 

 

 

5.00 A

5.18

---

4.96

---

4.79

5.09

5.04

---

5.07

0.26

101.5

5.00 B

5.33

---

5.03

---

---

---

5.29

---

 

 

 

5.00 C

---

5.17

---

4.33

---

---

---

5.30

 

 

 

5.00 D

---

5.31

---

5.09

---

---

---

5.11

 

 

 

10.0 A

11.0

---

9.9

---

10.3

11.1

10.8

---

10.6

0.34

105.7

10.0 B

10.6

---

10.1

---

---

---

10.5

---

 

 

 

10.0 C

---

10.5

---

10.4

---

---

---

10.9

 

 

 

10.0 D

---

10.6

---

10.5

---

---

---

10.8

 

 

 

NA = Not Applicable; LOQ = 0.06 mg a.i./L

1 Samples collected at 4:45 pm on 3/18/04 upon the discovery of a diluter malfunction (syringe pump not injecting toxicant)

2 Samples collected once the diluter malfunction had been corrected and the diluter had been cycled 20 times (6:55 PM 3/18/04)

Table 2: Time to Hatch for Fathead Minnows During the Test Item Early Life Stage Toxicity Test

Mean Measured Concentration (mg a.i./L)

Percent Hatch by Study Day a

 

Day 2

Day 3

Day 4

Day 5

Control A

0.0

0.0

94.3

94.3

Control B

0.0

0.0

91.4

91.4

Control C

0.0

0.0

94.3

97.1

Control D

0.0

0.0

94.3

97.1

Mean

0.0

0.0

93.6

95.0

0.58 ppm A

0.0

2.9

94.3

97.1

0.58 ppm B

0.0

0.0

88.6

88.6

0.58 ppm C

0.0

0.0

100.0

100.0

0.58 ppm D

0.0

0.0

100.0

100.0

Mean

0.0

0.7

95.7

96.4

1.10 ppm A

0.0

5.7

88.6

91.4

1.10 ppm B

0.0

0.0

85.7

88.6

1.10 ppm C

0.0

2.9

85.7

91.4

1.10 ppm D

0.0

0.0

88.6

91.4

Mean

0.0

2.1

87.1

90.7

2.37 ppm A

0.0

0.0

88.6

97.1

2.37 ppm B

0.0

0.0

85.7

85.7

2.37 ppm C

0.0

2.9

82.9

85.7

2.37 ppm D

0.0

2.9

88.6

88.6

Mean

0.0

1.4

86.4

89.3

5.07 ppm A

0.0

0.0

80.0

80.0

5.07 ppm B

0.0

0.0

94.3

97.1

5.07 ppm C

0.0

57.1

85.7

97.1

5.07 ppm D

0.0

0.0

80.0

85.7

Mean

0.0

14.3

85.0

90.0

10.6 ppm A

0.0

5.7

91.4

94.3

10.6 ppm B

0.0

2.9

88.6

91.4

10.6 ppm C

0.0

0.0

88.6

88.6

10.6 ppm D

0.0

0.0

88.6

94.3

Mean

0.0

2.1

89.3

92.1

a Percent Hatch = (# of alevin/# of eggs on Day 0) * 100

Table 3: Fry Survival During the test item Fathead Minnow Early Life Stage Toxicity Test

Mean Measured Concentrations (mg a.i./L)

Percent Survivorship

Day 5a

Day 35a

Control A

94.3

100.0

Control B

91.4

90.0

Control C

94.3

90.0

Control D

97.1

100.0

Mean

94.3

95.0

0.58 ppm A

97.1

100.0

0.58 ppm B

88.6

90.0

0.58 ppm C

100.0

95.0

0.58 ppm D

100.0

90.0

Mean

96.4

93.8

1.10 ppm A

91.4

90.0

1.10 ppm B

88.6

90.0

1.10 ppm C

91.4

85.0

1.10 ppm D

91.4

90.0

Mean

90.7

88.8

2.37 ppm A

97.1

90.0

2.37 ppm B

82.9

90.0

2.37 ppm C

85.7

90.0

2.37 ppm D

88.6

85.0

Mean

88.6

88.8

5.07 ppm A

80.0

75.0

5.07 ppm B

97.1

70.0

5.07 ppm C

94.3

60.0

5.07 ppm D

85.7

60.0

Mean

89.3

66.3*

10.6 ppm A

94.3

10.0

10.6 ppm B

91.4

15.0

10.6 ppm C

82.9

10.0

10.6 ppm D

91.4

20.0

Mean

90.0

12.5*

a Percent Survivorship = (# of alevin and eggs on day 5/# of eggs on Day 0) * 100

b Percent Survivorship = (# fry alive at study termination/# fish alive at transfer) * 100

* statistically significant effect (% = 0.05)

Table 4: Day 35 Standard Length and Weight for Fathead Minnows Exposed to the test item in the Early Life Stage Toxicity Test

Measured Concentration (mg a.i./L)

Mean Wet Weight (mg)

Mean Length (mm)

Mean Dry Weight (mg)

Control A

0.27

23.8

60.4

Control B

0.25

23.1

55.5

Control C

0.34

24.9

75.9

Control D

0.27

23.9

61.5

Mean

0.28

23.9

63.3

0.58 A

NA

23.2

59.2

0.58 B

NA

23.6

69.3

0.58 C

NA

23.3

65.3

0.58 D

NA

23.5

67.6

Mean

NA

23.4

65.3

1.10 A

NA

23.1

65.3

1.10 B

NA

22.1

61.0

1.10 C

NA

22.7

62.6

1.10 D

NA

23.0

67.3

Mean

NA

22.7*

64.1

2.37 A

NA

22.3

58.7

2.37 B

NA

22.4

56.7

2.37 C

NA

21.8

58.9

2.37 D

NA

21.5

55.8

Mean

NA

22.0*

57.5

5.07 A

NA

18.0

29.6

5.07 B

NA

16.9

24.0

5.07 C

NA

17.8

30.7

5.07 D

NA

17.4

25.4

Mean

NA

17.5*

27.4*

10.6 A

NA

9.8

1.6

10.6 B

NA

10.5

2.2

10.6 C

NA

12.3

6.1

10.6 D

NA

12.3

6.3

Mean

NA

11.2*

4.0*

NA = not applicable (wet weight measurements only required for control fish)

* statistically significant effect (% = 0.05)

Table 5: Validity criteria for OECD 210

Criterion from the guideline

Outcome

Validity criterion fulfilled

The dissolved oxygen concentration should be >60% of the air saturation value throughout the test.

The dissolved oxygen concentration was≥60% (Mean = 6.3±0.21 - 7.9±0.14) of the air saturation value throughout the test.

yes

The water temperature should not differ by more than ± 1.5 °C between test chambers or between successive days at any time during the test, and should be within the temperature ranges specified for the test species (Annex 2).

The water temperature ranged from 24.6 to 25.8 °C throughout the study.

yes

The analytical measure of the test concentrations is compulsory.

The mean measured concentrations of the test substance during the exposure period ranged from 87.9 to 105.7%.

yes

Overall survival of fertilised eggs and post-hatch success in the controls and, where relevant, in the solvent controls should be greater than or equal to the limits defined in Annex 2.

Survival of fertilised eggs was≥70% (95%) and post-hatch success was≥75% (95%), as defined in Annex 2, in the controls.

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 5 in "Any other information on results incl. tables".

Description of key information

NOEC (35 d) = 0.58 mg a.i./L (mean measured, growth rate and length, Pimephales promelas, OECD 210)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
NOEC
Effect concentration:
0.58 mg/L

Additional information

One experimental study is available investigating the effects of the fish early life stage for 35 d (M-123221-01-1). The study was performed according to OECD 210 (GLP) using Fathead Minnow (Pimephales promelas) as test organism under flow through conditions. The eggs starting at <24 hours old were observed for hatch rate. Young fish were assessed for abnormal behaviour, physical changes, mortality and growth (length, dry weight). Nominal concentrations were: Control, 0.63, 1.25, 2.50, 5.00 and 10.0 mg a.i./L. The mean measured concentrations of the test item during the exposure period were 0.58, 1.10, 2.37, 5.07 and 10.6 mg a.i./L, respectively. Observation for morphological and behavioural effects for treatment groups were consistent with the control group with the exception of the highest two test concentrations (5.07 and 10.6 mg a.i./L). For these two groups, morphological and behavioural effects were notably greater than in the control group. Further, mortality was significant in both of these concentrations. The 35-day exposure to the test item resulted in a NOEC of 0.58 mg a.i./L and a LOEC of 1.10 mg a.i./L based on growth (length).