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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In Section 13 of the IUCLID dossier, a report is attached in which the category approach is reported according to ECHA Guidance for the implementation of REACH, Guidance on information requirements and chemical safety assessment, Chapter R.6 (reporting format for a chemical category).
Reason / purpose:
exposure-related information
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
26.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
Recalculated from source to target
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
25.4 mg/L
Nominal / measured:
nominal
Conc. based on:
other: solid fraction
Basis for effect:
mobility
Details on results:
- Abnormalities observed: no
- After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the nominal test item concentration of 24.0 mg test item/L (9.4 mg solids/L). At the nominal concentration of 52.9 mg test item/L (20.7 mg solids/L), 7 animals were immobile and 18 animals were immobile at the nominal concentration of 116.2 mg test item/L (45.5 mg solids/L). At the highest test concentration of 255.4 mg test item/L (100 mg solids/L), 20 daphnids were immobile (see table 2).
- At test end, the test medium appeared to be slightly turbid at 116.2 mg test item/L (45.5 mg solids/L) and turbid at 255.4 mg test item/L (100 mg solids/L)
- The 95% confidence interval for the EC50 was calculated to be 52.7 -79.6 mg/L (20.6 -31.2 mg solids/L)
- Analysis showed that the test concentrations remained 84-100% of nominal test concentrations. Therefore, the effect concentrations were based on nominal test concentrations.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: 48h-EC50: 1.06 mg/L
- Other: based on the 24h-EC50 of 1.48 mg/L, the sensitivity was according to the proposed OECD levels (24h-EC50 between 0.6 and 2.1 mg potassium dichromate/L).
Reported statistics and error estimates:
The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis.
The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.

Table 1 Measured concentrations (data on source chemical)

Sample description

Concentration found

D.F.

Concentration calculated

Concentration nominal

(mg test item/L)

Sampling day

Age (h)

 (mg test item/L)*

1

(mg test item/L)*

 (mg test item/L)

% of nominal*

Control

0

0

<LOD

1

n.a.

0.000

n.a.

Control

0

0

<LOD

1

n.a.

0.000

n.a.

Control

2

48

<LOD

1

n.a.

0.000

n.a.

Control

2

48

<LOD

1

n.a.

0.000

n.a.

11

0

0

9.591

1

9.591

11.000

87

11

0

0

9.943

1

9.943

11.000

90

11

2

48

9.051

1

9.051

11.000

82

11

2

48

9.774

1

9.774

11.000

89

 

 

 

 

 

 

Mean value (n=4):

87

 

 

 

 

 

 

RSD (n=4):

4

24

0

0

20.932

1

20.932

2400

87

24

0

0

20.212

1

20.212

2400

84

24

2

48

19.591

1

19.591

2400

82

24

2

48

20.309

1

20.309

2400

85

 

 

 

 

 

 

Mean value (n=4):

84

 

 

 

 

 

 

RSD (n=4):

3

52.9

0

0

50.787

1

50.787

52.900

96

52.9

0

0

50.447

1

50.447

52.900

95

52.9

2

48

45.703

1

45.703

52.900

86

52.9

2

48

34.483

1

34.483

52.900

#65

 

 

 

 

 

 

Mean value (n=4):

93

 

 

 

 

 

 

RSD (n=4):

6

116.2

0

0

116.167

1

116.167

116.200

100

116.2

0

0

117.555

1

117.555

116.200

101

116.2

2

48

117.310

1

117.310

116.200

101

116.2

2

48

115.433

1

115.433

116.200

99

 

 

 

 

 

 

Mean value (n=4):

100

 

 

 

 

 

 

RSD (n=4):

1

255.4

0

0

126.955

2

253.909

255.400

99

255.4

0

0

125.225

2

250.449

255.400

98

255.4

2

48

118.792

2

237.583

255.400

93

255.4

2

48

122.773

2

245.546

255.400

96

 

 

 

 

 

 

Mean value (n=4):

97

 

 

 

 

 

 

RSD (n=4):

3

 

 

 

 

 

Overall mean value (n=20)

92

 

 

 

 

 

RSD (n=20)

7

* The tabulated results represent rounded results calculated on the exact raw data

LOD: Limit of Detection = 1 mg test item/L

n.a.: not applicable; RSD: Relative Standard Deviation; D.F.: Dilution factor

#considered to be an outlier, not used for calculation

Table 2 Influence of Miranol Ultra C32 on the mobility of Daphnia magna

Nominal concentration (mg test item/L)

No. of Daphnia tested

No. of immobilized Daphnia

% of immobilized Daphnia

 

 

After 24 h

After 48 h

After 24 h

After 48 h

Control

20

0

0

0

0

11

20

0

0

0

0

24

20

0

0

0

0

52.9

20

1

7

5

35

116.2

20

2

18

10

90

255.4

20

1

20

5

100

Validity criteria fulfilled:
yes
Remarks:
See 'overall remarks' section
Conclusions:
The 48h-EC50 for Miranol Ultra C32 towards Daphnia magna was 64.8 mg/L (25.4 mg solids/L). This result is read across to C8 Amphoacetates (recalculated EC50 is 26.7 mg/L (25.4 mg solids/L).
Executive summary:

A short term toxicity test was performed, according to OECD guideline 202 and GLP principles, to assess the potential of Miranol Ultra C32 to induce immobility in Daphnia magna.The test item was corrected for the solid fraction and added to the medium at nominal concentrations of 11, 24, 52.9, 116.2 and 255.4 mg test item/L (corresponding to 4.3, 9.4, 20.7, 45.5 and 100 mg solids/L). Twenty daphnia per concentration and a blank control, divided over four vessels, were exposed to the test solutions for 48 hours. The number of immobilised daphnids after 24 hours and 48 hours was recorded. Duplicate samples for analysis were taken at t=0 and t=48 to determine actual exposure concentrations. Analysis showed that the test concentrations remained 84-100% of nominal test concentrations and thus the effect concentrations were based on nominal test concentrations.

In the lowest concentrations (11 and 24 mg/L) no daphnids became immobilised, while in the highest concentration all daphnids became immobilised. The 48h-EC50 of Miranol Ultra C32 was determined to be 64.8 mg/L (25.4 mg solids/L) with 95% confidence interval 52.7 -79.6 mg/L (20.6 -31.2 mg solids/L). All validity criteria were met and the study was considered to be valid. This result is read across to C8 Amphoacetates (recalculated EC50 is 26.7 mg/L (25.4 mg solids/L).

Description of key information

The 48h-EC50 for substance analogue Miranol Ultra C32 towards Daphnia magna was 64.8 mg/L (25.4 mg solids/L). This result is read across to C8 Amphoacetates (based on a solid content of 95%, this correlates to 26.7 mg C8 Amphoacetates/L).

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
26.7 mg/L

Additional information