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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned
Study period:
2020-2021

Data source

Reference
Reference Type:
other: draft study plan
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
EC Number:
216-475-4
EC Name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
Cas Number:
1594-08-7
Molecular formula:
C21H15NO6S
IUPAC Name:
1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Physical appearance: Black powder
Purity as per CoA: 99.1 % (w/w)
Batch No.: 1404301
Manufactured date: 20 September 2014
Expiry date: 08 April 2024
Density: 1.2654 g/cm³
pH: 5.0 (susp. of 2 % (w/w) in water)
Recommended storage condition: Ambient (+15 to +25 °C)

Sampling and analysis

Analytical monitoring:
yes

Study design

Test type:
semi-static
Water media type:
freshwater

Results and discussion

Any other information on results incl. tables

1.Results

1.1 Test Item Solubility


The test item formed suspension after introduction into acetone and Elendt M4 medium at 0.1 mg/mL (performed as pre-study).


1.2   Range Finding Test


Range finding test results are presented in Tables 1 to 5.


Range finding test resulted in toxic effects on survival and reproduction of daphnids.
























































Concentration (mg/L)



Parent mortality (%) out of 2



Average offspring produced per parent animal



%RO



G1-Control



0



83.0



-



G2-Vehicle control



0



82.5



-0.6



G3-0.1



0



83.5



0.6



G4-1



50



71.0



-14.5



G5-10



100



41.0



-50.6



G6-50



100



0.0



-100.0



G7-100



100



0.0



-100.0



%RO: % Reduction in offspring production


Male neonates and ephippia were not observed during the test. There were no instances of aborted eggs, aborted broods or dead offspring (except in G4 and G5) in the control, vehicle control and any of the test item treated groups.


1.3 Definitive Test


Definitive test results are presented in Tables 6 to 12.


Refer Figures 1 to 4 for reproductive output against the test concentrations and parent animal mortality during the test.


There was no mortality of parent animals in the control and vehicle control. The mortality of parent animals was 0, 0, 0, 60 and 100 % on day 21 of exposure at the test concentrations of 0.03, 0.06, 0.19, 0.67 and 2.23 mg/L (respective nominal test concentrations are 0.06, 0.18, 0.54, 1.62 and
4.86 mg/L), respectively (Table 7).


The percent change in reproductive output of parent animals was 0.4,               -28.1, -38.4, -46.5 and -61.0 % at the test concentrations of 0.03, 0.06, 0.19, 0.67 and 2.23 mg/L, respectively. Reproductive output of parent animals evidenced statistically significant reduction in the tested concentrations of 0.06, 0.19, 0.67 and 2.23 mg/L as compared with the vehicle control group (Table 9). Analysis of the number of living offspring per surviving parent animal also evidenced statistically significant reduction in the tested concentrations of 0.06, 0.19 and 0.67 mg/L as compared with the vehicle control group.


Time to production of first brood (and subsequent broods), number and size of broods evidenced prolongation (production of broods) and reduction (number and size of broods) in the tested concentrations of 0.06, 0.19, 0.67 and 2.23 mg/L as compared with the vehicle control group (Table 10).


The percent production of male offspring was 0% in all the test concentrations of 0 (control), 0 (vehicle control), 0.03, 0.06, 0.19, 0.67 and 2.23 mg/L (Table 11).


Measurement of the length of the parent animals at the end of the test
(day 21) evidenced statistically significant reduction in the tested concentrations of 0.06, 0.19, 0.67 and 2.23 mg/L as compared with the vehicle control group (Table 12).


Intrinsic rate of population increase evaluation evidenced reduction at the tested concentrations of 0.06, 0.19, 0.67 and 2.23 mg/L as compared with the vehicle control. Abnormal and dead neonates were excluded during determination of intrinsic rate of population increase to obtain actual values.  


Male neonates and ephippia were not recorded during the test. There were no instances of aborted eggs, aborted broods or dead offspring (except in G5 to G7) in the control, vehicle control and any of the test item treated groups.


Reproduction endpoints were determined as total living offspring per maternal organism (parent animal) which did not die accidentally or inadvertently during the test.


The effects of FAT 36038/J TE on parent animals (Daphnia magna) mortality, growth effects (length of the parent animals) and reproduction based on nominal and time-weighted mean test concentrations are as below:



























































































Endpoints



Nominal conc. (mg/L)



*Measured conc. (mg/L)



95% Fiducial Limits (mg/L)



Lower



Upper



Mortality



NOEC



0.54



0.19



-



-



LOEC



1.62



0.67



-



-



LC50



1.592



0.6564



-



-



Growth effects



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



Reproduction



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



EC10



0.03886



0.01337



0.0003451


(0.002894)



0.07074


(0.1576)



EC20



0.1616



0.06027



0.007218


(0.03436)



0.1912


(0.4213)



EC50



1.846



0.7908



0.3364


(0.9251)



3.634


(5.404)



*: Based on time-weighted mean test concentrations. Values in parentheses are fiducial limits based on nominal test concentrations in mg/L.


1.4 Analytical Verification of Test Item Concentration in Test Medium


For the stability and definitive test analytical results refer Appendix 2


The stability test results concluded that the test item was stable in the Elendt M4 medium at 72 h in the nominal concentrations of 0.0510 and
200.400 mg/L.


The results of test item analysis of test concentrations of 0.06, 0.18, 0.54, 1.62 and 4.86 mg/L showed that overall percent agreement was as below:





















Sample



Mean Minimum (%)



Mean Maximum (%)



0 h Fresh



50.97



106.25



48 h Aged



7.42



35.17



Since the deviation from the measured initial concentration was greater than ± 20%. Hence, the results were expressed in terms of the time-weighted mean. Time-weighted mean test concentrations are 0.03, 0.06, 0.19, 0.67 and 2.23 mg/L (respective nominal test concentrations are 0.06, 0.18, 0.54, 1.62 and 4.86 mg/L). The analytical measurements of FAT 36038/J TE in test medium varied in random fashion. In most occasions, the analytical measurements were more than ± 20% from the nominal concentration during the test. This variation in analytical measurements doesn’t have any impact on the outcome of the test, since test concentrations are based on time-weighted mean measured concentrations (which provide exposure scenario of test item).


2. CONDITIONS FOR THE Validity of the Test


This test has met all the validity criteria in the control(s):



  • The mortality of the parent animal (female daphnia) was 0% (control and vehicle control) at the end of the test (acceptable criterion: mortality of the parent animal should not exceed 20% at the end of the test).

  • The mean number of live offspring produced per parent animal surviving at the end of the test is ≥ 79.8 and 80.3 in the control and vehicle control, respectively (acceptable criterion: ≥ 60).

  • Maximum male offspring produced was 0 % in the control and vehicle control (acceptable criterion: no more than 5 % male offspring).

  • The accidental and inadvertent parental mortality for the control(s) as well as for each of the test concentration was 0 % (acceptable criterion: should not exceed 20 % at the end of the test).


3. conclusion


The effects of FAT 36038/J on parent animals (Daphnia magna) mortality, growth effects (length of the parent animals) and reproduction based on nominal and time-weighted mean test concentrations are as below:


 


 



























































































Endpoints



Nominal conc. (mg/L)



*Measured conc. (mg/L)



95% Fiducial Limits (mg/L)



Lower



Upper



Mortality



NOEC



0.54



0.19



-



-



LOEC



1.62



0.67



-



-



LC50



1.592



0.6564



-



-



Growth effects



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



Reproduction



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



EC10



0.03886



0.01337



0.0003451


(0.002894)



0.07074


(0.1576)



EC20



0.1616



0.06027



0.007218


(0.03436)



0.1912


(0.4213)



EC50



1.846



0.7908



0.3364


(0.9251)



3.634


(5.404)



*: Based on time-weighted mean test concentrations. Values in parentheses are fiducial limits based on nominal test concentrations in mg/L.


 


 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The effects of FAT 36038/J TE on parent animals (Daphnia magna) mortality, growth effects (length of the parent animals) and reproduction based on nominal and time-weighted mean test concentrations are as below:


 


 



























































































Endpoints



Nominal conc. (mg/L)



*Measured conc. (mg/L)



95% Fiducial Limits (mg/L)



Lower



Upper



Mortality



NOEC



0.54



0.19



-



-



LOEC



1.62



0.67



-



-



LC50



1.592



0.6564



-



-



Growth effects



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



Reproduction



NOEC



0.06



0.03



-



-



LOEC



0.18



0.06



-



-



EC10



0.03886



0.01337



0.0003451


(0.002894)



0.07074


(0.1576)



EC20



0.1616



0.06027



0.007218


(0.03436)



0.1912


(0.4213)



EC50



1.846



0.7908



0.3364


(0.9251)



3.634


(5.404)



*: Based on time-weighted mean test concentrations. Values in parentheses are fiducial limits based on nominal test concentrations in mg/L.

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