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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study according to protocol.
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
Cited as OECD Guide-line 202, part 2 (Daphnia sp., Reproduction Test)
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-4: “Daphnia magna life-cycle (21-day renewal) chronic toxicity test” (US EPA 1985)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
During this study, 25 mg A.l./mL stock solutions were prepared by dissolving approximately 4.92 g (5.0 g as active ingredient) of test material with reagent grade water to volume in a 200 mL volumetric flask. The resulting stock solutions were observed to be clear and colorless.
Stock solutions were prepared in this manner one day prior to test initiation and on days 1, 3, 5, 7 and 9. Stock solutions were also prepared on test days 11 and 17 by dissolving approximately 12.3 g (1 2.5 g as A.I.) of test material with reagent grade water to volume in a 500-mL volumetric flask. The resultant stock solutions were also observed to be clear and colorless.
Following preparation, the stock solutions were transferred to a 250-mL graduated cylinder for use in the diluter system. Any remaining stock solution was transferred to an amber colored glass stock bottle and stored at room temperature.
The diluter system was equipped with a Harvard Peristaltic pump which delivered 0.385 mL of the Chloramine-T stock solution (25 mg A.l./mL) into the diluter system's chemical mixing chamber which also received 0.386 L of dilution water during each diluter cycle. The solution contained in the mixing chamber constituted the highest nominal test concentration (25 mg A.I./L). This solution was proportionally diluted (50% dilution factor) to provide the remaining nominal test concentrations: 13, 6.3,3.1 and 1.6 mg A.I./L.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Source: Springborn Laboratories, Inc., Warehem, Massechutes, USA
- Age: ≤ 24 hours
- Breeding method: Daphnids are obtained by removing all immature daphnids from the culture vessel. This way sexually mature daphnids are isolated 24 hours prior to initiating the test. The young produced by these isolated organisms are pipetted into the test beakers
- Kind of food: Combination of green algae (Ankistrodesmus falcatus) and a trout food suspension supplemented with a fatty acid additive (Selco®). The food solution contains 5 mg/mL trout food, 0.6 mg/L Selco®and approximately 4x107cells/mL algae
- Amount of food: During the treatment period food was introduced at a rate of 2.0 mL trout food, 3.0 mL algae and 0.5 mL Selco® at each feeding time
- Feeding frequency: In culture prior to the test the daphnids are fed daily. During the 21-day test the organisms are fed three times daily during weekdays and twice on weekend days
- Pretreatment: None
- Feeding of animals during test: Yes; food solutions were added to the exposure solution prior to the introduction of the daphnids.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
170-180 mg/L CaCO3 (SD = 4)
Test temperature:
19 - 20 °C
pH:
8.0 - 8.3
Dissolved oxygen:
8.6 - 8.7 mg/l
Nominal and measured concentrations:
Nominal: 1.6, 3.1, 6.3, 13 and 25 mg A.I./L
measured: 1.1, 3.5, 6.3, 12 and 23 mg A.I./L
Details on test conditions:
- Renewal of test solution: The flow rate is approximately 6 test vessel volumes per day, 90% solution replacement in 9 hours
- Volume of test vessels: 1.8 L
- Volume/animal: 0.18 L per daphnid
- Number of animals/vessel: 10 animals per vessel
- Number of vessels/ concentration: 4 vessels per concentration
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: length and no. offspring/female
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
3.5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: length and no. offspring/female
Duration:
21 d
Dose descriptor:
other: MATC
Effect conc.:
2 mg/L
Details on results:
For mortality the 21 day EC50 was empirically estimated to be > 23 mg A.I./L. At study termination no adverse sublethal effects were observed at any tested concentration.
For reproduction a dose dependent decrease in number of offspring was observed. The lowest treatment level was comparable to the control animals. A dose dependent decrease in mean total body length was observed. The lowest treatment level was comparable to the control animals. The mean dry weight was significantly different from the control animals in the two highest dose groups and in the lowest dose group. Since no other effects were observed in the lowest dose group this finding was considered not to be treatment related.
Reported statistics and error estimates:
significance of differences were determined using Dunnett's test (data distribution was checked using Bartlet's test and Shapiro Wilks test). End-points were compared to controls.

METHOD OF CALCULATION: Immobility, reproduction was compared to control and differences were statistically determined.

RANGE FINDING TEST

100% immobility was observed at 100 mg/l, < 15% was observed at 6.3-50 mg/l.

EXPOSED
- Nominal/measured concentrations: nominal (see TC),
measured : 23-12-6.3-3.5 and 1.1 mg/l (average recovery of 93% of the nominal values)
- Effect data: 95-100% survival at the exposed test
concentrations 1.1 - 23 mg/l. No concentration elicited
greater than 50% immobilization, the EC50 was empirically
estimated at > 23 mg/l.
- Other effects: no significant effects observed 

CONTROL
- Number/percentage of animals showing adverse effects: The reproduction and mean total length was significantly
affected at the concentrations 3.5-6.3-12 and 23 mg/l. At
1.1 mg/l, the offspring and mean length was comparable to
the control. At 23 and 12 mg/l the mean dry weight was
significantly lower as compared to the control. 
- Nature of adverse effects: number of offspring, weight and length

Survival, offspring, length and weight of Daphnia magna at the end of the test

Mean measured concentration (mg A.i./L)

Mean percent survival at day 21 (SD)*

Mean number of offspring/female

Total number of offspring alive**

Mean length (mm) (SD)*

Mean dry weight (mg) (SD)*

Control

90(8)

245(15)

9499

5.4(0.2)

1.63(0.15)

1.1

95(6)

268(15)

10592

5.3(0.2)

1.22(0.28)

3.5

98(5)

212(21)

8298

5.2(0.2)

1.59(0.18)

6.3

100(0)

173(23)

6889

5.2(0.2)

1.46(0.17)

12

98(5)

133(15)

5151

4.7(0.3)

1.15(0.21)

23

98(5)

61(19)

2362

4.2(0.3)

0.86(0.15)

* standard deviation

** No offspring was found immobilized

Validity criteria fulfilled:
yes
Conclusions:
No effect was seen on the survival of the exposed daphnids as compared with the control animals. For the number of offspring (no effect lowest dose), mean total body length (no effect lowest dose) and mean dry weight (effect two highest and lowest doses) a dose response related decrease was observed. The decrease seen in the lowest dose tested was considered not to be treatment related.
Executive summary:

The purpose of this study was to estimate the chronic toxicity of Tosylchloramide sodium to daphnids (Daphnia magna) under flow-through conditions. Forty Daphnia magna per treatment level (ten per replicate vessel) were continuously exposed for 21 days to nominal Tosylchloramide sodium concentrations of 25, 13, 6.3, 3.1 and 1.6 mg A.I./L and a dilution water control. Nominal test concentrations were selected based on an eight day flow-through preliminary test conducted at Sprinborn Laboratories at concentrations of 6.3 - 100 mg A.I./L Tosylchloramide sodium. Observations on adult organism survival, reproduction and growth (mean total length and dry weight) as well as the number of immobilized young were recorded during the definitive exposure to determine the effects of the test material on these standard performance criteria.

During the 21-day study, weekly analyses of the exposure solutions established that the diluter system functioned properly throughout the test period and maintained mean measured concentrations of test material which averaged 93% of the nominal levels. Based on measured concentrations of Tosylchloramide sodium, the exposure levels were defined as 23, 12, 6.3, 3.5 and 1.1 mg A.I./L. Throughout the study, no undissolved Tosylchloramide sodiumT (e.g., precipitate, film on solution's surface) was observed in the diluter system or in any of the exposure vessels. Weekly, or more frequently, measurement of temperature, dissolved oxygen, pH, specific conductance, total hardness and alkalinity in the exposure solutions established that these standard water quality parameters were unaffected by the concentrations of Tosylchloramide sodium tested and remained within acceptable limits for the survival, reproduction and growth of daphnids.

At the termination of the 2l day exposure, the control daphnids survived (90% survival) and reproduced (averaged 245 offspring per female) at rates which exceeded the minimum standard criteria established by the US. EPA under FlFRA Guideline #72-4 (i.e., ≥ 70% survival, ≥ 40 offspring per female). Survival among daphnids exposed to the concentrations tested (23 - 1.1 mg A.I./L) ranged from 95 - 100% and were statistically similar to the survival of the control organisms. Since no concentration tested elicited greater than 50% immobilization, the 21-day EC50 value was empirically estimated to be > 23 mg A.I./L, the highest mean measured

concentration tested.

Reproduction, determined as the mean number of offspring per female at test termination (day 21), among daphnids exposed to the four highest treatment levels (23, 12, 6.3 and 3.5 mg A.I./L) averaged 61, 133, 173 and 212 offspring per female, respectively, and were significantly reduced as compared to the performance of the control organisms (245 offspring/female). Reproduction among organisms exposed to the remaining treatment level (1.1 mg A.I./L) averaged 268 offspring/female, and was comparable to the performance of the control organisms.

After 21 days of exposure, mean total length of organisms exposed to the 23,12,6.3 and 3.5 mg A.I./L treatment levels averaged 4.2, 4.7, 5.2 and 5.2 mm, respectively and were statistically reduced as compared to the mean total length of the control organisms (5.4 mm).

Mean total length of organisms exposed to the remaining concentration tested (1.1 mg A.I./L) averaged 5.3 mm, and was statistically comparable to the mean total length of the control organisms.

Mean dry weight among organisms exposed to the 23 and 12 mg A.I./L treatment levels were 0.86 and 1.15 mg, respectively, and were statistically reduced as compared to the mean dry weight of the control organisms (1.63 mg). Mean dry weight of organisms exposed to the 6.3 and 3.5 mg A.I./L treatment levels averaged 1.46 and 1.59 mg, respectively, and were statistically comparable to the mean dry weight of the control organisms. The mean dry weight of organisms exposed to the 1.1 mg A.I./L treatment level was 1.22 mg which was also determined to be significantly reduced when compared to the control organisms. However, no significant effect was observed at the 6.3 and 3.5 mg A.I./L test concentrations for the mean dry weight, and no significant effect was observed at the 1.1 mg A.I./L test concentration for mean total length, the significant effect determined for mean dry weight at the 1.1 mg A.I./L test concentration is not considered to be treatment related.

The data generated during the 21 -day exposure established that an adverse effect on reproduction and mean total body length were the most sensitive indicators of the toxicity of Tosylchloramide sodium to Daphnia magna. The Lowest-Observed-Effect Concentration (LOEC) for Tosylchloramide sodiumwas determined to be 3.5 mg A.I./L and the No-Observed-Effect Concentration .

(NOEC) for this study was established to be 1.1 mg A.I./L. Analyses of these data determined the Maximum Acceptable Toxicant Concentration (MATC) of Tosylchloramide sodium to D. magna to be < 3.5 mg A.I./L and > 1.1 mg A.I./L (Geometric Mean MATC = 2.0 mg A.I./L).

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
the raw data is not available to evaluate the results and there is no description of the chemical product specification, neither about the analytical method used to determine the compound concentration. These deficiencies are however not considered to have major consequences on the results obtained in the study.
Principles of method if other than guideline:
According to:
Provisional Procedure: extended toxicology test with Daphnia magna (determination of NOEC for reproduction rate, mortality and the time of first appearance of offspring, 21d), 1984 from the ‘Recommendation of the Federal Environmental Agency on the performance of testing according to section 5, para 1 No 3 of the regulation on application documents and evidence under the chemical act’

Deviations:
Yes: the chemical determination of the substance concentrations was modified as follows: samples were taken twice during the test period and analysed chemically. The first sampling took place on one of the transfer days before the 7th day, i.e. in a period during which no offspring appeared. The second sampling took place between the 16th and 21st day. These modifications are believed not to influence the results of the study and its validity
Main deviation from OECD 211: test temperature of 25°C instead of 18-22, animals not held individually but 5 animals per vessels, light for 9 hr instead of 16 hr. These deviations are not considered to negatively influence the validity of the test and results
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Daphnia magna
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1.3 mg/L
Nominal / measured:
nominal
Basis for effect:
other: reproduction rate and appearance of first offspring
Validity criteria fulfilled:
not specified
Conclusions:
The NOEC for appearance of offspring and reproduction is 1.3 mg/l.

Description of key information

The purpose of the study was to estimate the chronic toxicity of Tosylchloramide sodium to daphnids (Daphnia magna) under flow-through conditions. Forty Daphnia magna per treatment level (ten per replicate vessel) were continuously exposed for 21 days to nominal Tosylchloramide sodium concentrations of 25, 13, 6.3, 3.1 and 1.6 mg A.I./L and a dilution water control.Nominal test concentrations were selected based on an eight day flow-through preliminary test conducted at Sprinborn Laboratories at concentrations of 6.3 - 100 mg A.I./L Tosylchloramide sodium. Observations on adult organism survival, reproduction and growth (mean total length and dry weight) as well as the number of immobilized young were recorded during the definitive exposure to determine the effects of the test material on these standard performance criteria.

During the 21-day study, weekly analyses of the exposure solutions established that the diluter system functioned properly throughout the test period and maintained mean measured concentrations of test material which averaged 93% of the nominal levels. Based on measured concentrations of Tosylchloramide sodium, the exposure levels were defined as 23, 12, 6.3, 3.5 and 1.1 mg A.I./L. Throughout the study, no undissolved Tosylchloramide sodium (e.g., precipitate, film on solution's surface) was observed in the diluter system or in any of the exposure vessels. Weekly, or more frequently, measurement of temperature, dissolved oxygen, pH, specific conductance, total hardness and alkalinity in the exposure solutions established that these standard water quality parameters were unaffected by the concentrations of Tosylchloramide sodium tested and remained within acceptable limits for the survival, reproduction and growth of daphnids.The data generated during the 21 -day exposure established that an adverse effect on reproduction and mean total body length were the most sensitive indicators of the toxicity of Tosylchloramide sodium to Daphnia magna. The Lowest-Observed-Effect Concentration (LOEC) for Tosylchloramide sodium was determined to be 3.5 mg A.I./L and the No-Observed-Effect Concentration (NOEC) for this study was established to be 1.1 mg A.I./L. Analyses of these data determined the Maximum Acceptable Toxicant Concentration (MATC) of Tosylchloramide sodium to D. magna to be < 3.5 mg A.I./L and > 1.1 mg A.I./L (Geometric Mean MATC = 2.0 mg A.I./L).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1.1 mg/L

Additional information

Both a flow-through (48h NOEC = 1.1) and semi-static test (48h NOEC = 1.3) was carried out with Chloramine T and Daphnia magna. The study with highest reliability score (and worst-case result) was used.