4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 August - 3 September 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

(2008)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Version / remarks:

(2008)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ISO International Standard - 10706 (2000)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (control) and 100 mg/L (loading rate)

- Sampling method: Duplicate samples for analysis were taken from both test groups. The filter containing the undissolved residue was also retained for possible analysis.

Frequency: At the beginning and at the end of two intervals of 48 hours (nominal days 8 and 10, 15 and 17) and one interval of 72 hours (nominal days 0 and 3).
Volume: 50 ml

- Sample storage conditions before analysis: samples were freshly analysed.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test solutions were prepared at the limit of solubility in test medium by magnetic stirring of a loading rate of 100 mg/L for three subsequent days. The major fraction of undissolved test material was then removed by filtration through a rough paper filter (Whatman 597; pore size ~4-7 μm). The resulting clear and colourless filtrate was used for testing.

- Controls: Test medium only (without test substance or other additives)

- Evidence of undissolved material (e.g. precipitate, surface film, etc): After filtration no undissolved material was observed in the test solution

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: In-house laboratory culture with a known history
- Feeding during test
- Food type: Chlorella pyrenoidosa suspension
- Amount and frequency: daily ration corresponded to at least 0.2 mg C/Daphnia/day,

ACCLIMATION
- Acclimation period: Not required

- Validity of the batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

196 - 250 mg CaCO3/L

Test temperature:

18.7 - 20.4 °C (for a short period on day 1 of the study the temperature increased to a maximum of 22.3°C)

pH:

7.6 - 8.4

Dissolved oxygen:

7.1 - 10.2 mg/L

Nominal and measured concentrations:

- Nominal: A filtered solution prepared at a loading rate of 100 mg/L plus a control (0 mg/L)

- Measured: The area of the major peak at 4.5 minutes (‘peak 1’) and the area of one of the two largest minor peaks at 7.3 minutes (‘peak 3’) were used as test substance response in the calculations. The average exposure concentration was concluded to be 0.2 mg/L being the highest average measured concentration and based on peak 3. Testing was performed at or above the limit of water solubility.

Details on test conditions:

TEST SYSTEM
- Test vessel: All-glass
- Type: Covered with Perspex plate
- Material, size, headspace, fill volume: All-glass, with 60 ml of capacity and filled with 50 ml of test solution.
- Aeration: None
- Renewal rate of test solution (frequency): Three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 20
- No. of vessels per control (replicates): 20

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light - 8 hours dark
- Light intensity:
At the start: 620-763 lux (8.9-10.0 μE.m-2.s-1)
At the end: 609-719 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Parental daphnids
Condition: Every workday, the number of living, immobile and dead parental daphnids was recorded. Dead daphnids were removed when observed.
Presence of eggs in the brood pouch: Every workday.
Body length: At the end of the test.

- Offspring
Appearance first brood: When observed.
Newborn daphnids: Every workday, the number of newborn young was counted and the condition of the young recorded. Thereafter the young were removed.
Presence of unhatched eggs: When observed.
Incidence of immobility: When observed.

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

NOEC

Basis for effect:

other: parental body length, reproduction, growth, survival

Remarks on result:

other: Since no effects were observed in a WSF prepared at a loading rate of 100 mg/L, the NOEC is considered to be equal to the maximum soluble test substance concentration in test medium.

Details on results:

- Temperature: Continuous measurement of the temperature indicated a short rise in temperature on day 1 of the study to a value just above the optimum limit of 22°C. The highest temperature measured was 0.3°C above the optimal range as prescribed by the protocol. The temperature was only above the optimum for a period of 2 hours, which did not affect the well-being of the daphnia.

- Mortality of parent animals:
Control group: 2
0.2 mg/L test group: 2

- Cumulative mean number of living offspring produced per parent during the test period:
Control group: 116.9
0.2 mg/L test group: 124.7

- Average body length of parent animals (mm):
Control group: 4.22
0.2 mg/L test group: 4.33

- Type and number of behavioural abnormalities: No significant numbers of immobilised young were observed in the control or the SPB-100 (SPE-100,SPS-100) test group. In the control two immobilised young were observed, while no immobilised young were observed in the SPB-100 (SPE-100,SPS-100) test group. The immobilised young were not taken into consideration for reproduction.

- Time to first brood release or time to hatch: At day 8

- Other biological observations: There were no recordings of unhatched (aborted) eggs in the two test groups throughout the 21-day test period.

- Effect concentrations exceeding solubility of substance in test medium: Yes

Reported statistics and error estimates:

- Statistical analysis: No statistical analyses were performed as they were not deemed necessary as a consequence of the observed effects.

Overview of measured and mean exposure concentrations
Loading rate SPB-100 (SPE-100,SPS-100) (mg/L)	Measured concentrations (μg/L)						Average day 0-21 (μg/L)
	Day 0-3	Mean	Day 8-10	Mean	Day 15-17	Mean
100 (filtrate)	peak 1: 83-32	52	peak 1: 41-12	22	peak 1: 722-238	415	peak 1: 163
	peak 3: 74-33	49	peak 3: 39-17	26	peak 3: 869-315	523	peak 3: 199

Cumulative mortality of parental daphnids during the 21-day exposure period.
Average conc. (SPE-100,SPS-100) (mg/L)	Number exposed	Cumulative number of dead parental daphnids on day:												Mortality (%)
		2	6	7	8	9	10	14	15	17	18	20	21
Control	20	0	0	0	0	0	0	0	1	2	2	2	2	10
0.2	20	0	0	0	0	0	0	0	1	1	1	2	2	10

Cumulative mean number of living young per parent in the control and the limit SPB-100 (SPE-100,SPS-100) concentration (in mg/L) during the 21-day test period
	Day
	7	8	9	10	13	14	15	16	17	20	21
Control	0	9.1	9.1	9.1	29.2	44	59.6	60.7	60.8	85.8	116.9
0.2 mg/l	0	11.6	11.6	11.6	39.3	63.6	65.6	65.6	66.3	90.6	124.7

Average body lengths (mm) of parental daphnids with the standard deviation (SD) per concentration measured at the end of the test and the percentage reduction of body length relative to the control.
Average conc. SPB-100 (SPE-100,SPS-100) (mg/L)	Average length (mm)	SD	Reduction (%)
Control	4.22	0.12
0.2	4.33	0.13	0

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study SPS-100 did not affect reproduction, growth or survival of Daphnia magna at 0.2 mg/L after 21 days of exposure, being the average concentration measured in filtered test solutions prepared at a loading rate of 100 mg/L. In a 21-day semi-static reproduction study, the toxicity of SPS-100 to aquatic invertebrate Daphnia magna was assessed according to OECD Guideline No. 211 (2008) and GLP principles. Nominal concentration was prepared at a loading rate of 100 mg/L and the resulting average concentration measured in the filtered test solutions was 0.2 mg/L. SPS-100 did not affect reproduction, growth or survival of Daphnia magna at the maximum solubility in test medium (0.2 mg/L) after 21 days of exposure. Therefore, it was concluded that the test substance it is not toxic up to the solubility limit. All criteria for acceptability of the test were met according to OECD guideline No. 211 and the study is considered to be reliable without restrictions.

Executive summary:

In a 21-day semi-static reproduction study, the toxicity of SPS-100 to aquatic invertebrate Daphnia magna was assessed according to OECD Guideline No. 211 (2008) and GLP principles. Nominal concentration was prepared at a loading rate of 100 mg/L and the resulting average concentration measured in the filtered test solutions was 0.2 mg/L. SPS-100 did not affect reproduction, growth or survival of Daphnia magna at the maximum solubility in test medium (0.2 mg/L) after 21 days of exposure. Therefore, it was concluded that the test substance it is not toxic up to the solubility limit. All criteria for acceptability of the test were met according to OECD guideline No. 211 and the study is considered to be reliable without restrictions.

Description of key information

In a 21-day semi-static reproduction study, the toxicity of SPS-100 to aquatic invertebrate Daphnia magna was evaluated. SPS-100 did not affect reproduction, growth or survival of Daphnia magna at the maximum solubility in test medium (0.2 mg/L) after 21 days of exposure. Therefore, it was concluded that the test substance it is not toxic up to the solubility limit. All criteria for acceptability of the test were met according to OECD guideline No. 211 and the study is considered to be reliable without restrictions.

Additional information

In a 21-day semi-static reproduction study, the toxicity of SPS-100 to aquatic invertebrate Daphnia magna was assessed according to OECD Guideline No. 211 (2008) and GLP principles. Nominal concentration was prepared at a loading rate of 100 mg/L and the resulting average concentration measured in the filtered test solutions was 0.2 mg/L. SPS-100 did not affect reproduction, growth or survival of Daphnia magna at the maximum solubility in test medium (0.2 mg/L) after 21 days of exposure. Therefore, it was concluded that the test substance it is not toxic up to the solubility limit. All criteria for acceptability of the test were met according to OECD guideline No. 211 and the study is considered to be reliable without restrictions.