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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:
18 Jan - 09 Feb 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to category justification provided in IUCLID section 13.
Qualifier:
according to
Guideline:
other: OECD Guideline 202 Part II
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Two stock solutions were prepared (1600 mg/L; 200 mg/L). The substance was heated before the initial weight (approx. 50 °C). Stock solutions were renewed every second or third day and stored in refrigerator (approx. 4 °C).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain/clone: Straus 1820
- Source: In-house stock TTB-Ökologie, Henkel KGaA
- Feeding during test
- Food type: Scenedesmus subspicatus
- Amount: 0-7 days old species: 2.5*10^6 cells/daphnia/day / > 7 days old species: 5.0*10^6 cells/daphnia/day
- Frequency: every day
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
not stated
Test temperature:
21.7 - 22.0 °C
pH:
7.5 - 8.3 (control)
8.0 - 8.1 (highest test concentration)
Dissolved oxygen:
93-102%
Nominal and measured concentrations:
Nominal concentrations: 0, 1, 2, 4, 8, 16 mg/L
Measured concentrations for the nominal concentration of 2 mg/L: 2.1 mg/L (0 h); 1.9 mg/L (24 h) measured on day 6
Measured concentrations for the nominal concentration of 2 mg/L: 2.1 mg/L (0 h); 1.7 mg/L (24 h) measured on day 14
Measured concentrations for the nominal concentration of 2 mg/L: 1.9 mg/L (0 h); 1.8 mg/L (24 h) measured on day 21
Measured concentrations for the nominal concentration of 4 mg/L: 3.9 mg/L (0 h); 3.4 mg/L (24 h) measured on day 14
Measured concentrations for the nominal concentration of 4 mg/L: 3.8 mg/L (0 h); 3.6 mg/L (24 h) measured on day 21
Measured concentrations for the nominal concentration of 8 mg/L: 8.4 mg/L (0 h); 7.9 mg/L (24 h) measured on day 7
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL conical-flasks
- Type: slightly closed
- fill volume: 50 mL
- Renewal rate of test solution: every day
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-Elendt medium


OTHER TEST CONDITIONS
- Photoperiod: 16/8 h
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.76 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: recalculated from raw data
Reported statistics and error estimates:
A re-evaluation of the raw data has been conducted in order to obtain more reliable and robust ECx values instead of NOEC values. Recent scientific developments have led to a recommendation of abandoning the concept of NOEC and replacing it with regression based point estimates ECx.
A nonlinear regression using the 4-parameter logistic was performed on the raw data for mortality, using ToxRatStd Version 2.10@ software.
Parameters of the logistic equation: a = 96,33479, b = 23,54864, c = 3,86749, d = 0,00000. Sum of squared residuals: 80,66682.

Because of the good degradability of the substance the test setup was renewed every day. The species were transfered to new test vessels with renewed test solutions. The chemical analysis resulted in a recovery of the substance of more than 80%. Therefore, the nominal concentrations were used for the determination of the NOECs. The most sensitive endpoint for the substance was the mortality (NOEC: 2 mg/L (= 1 mg active matter/L); recalculated EC10: 3.52 mg/L (= 1.76 mg active matter/L)).

Results of the statistical re-evaluation:

EC10: 3.523 mg product/L, equivalent to 1.762 mg a.i./L

EC20: 3.646 mg product/L, equivalent to 1.823 mg a.i./L

EC10: 3.867 mg product/L, equivalent to 1.934 mg a.i./L

For details see attached statistical report.

Endpoint:
long-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:
Refer to category justification provided in IUCLID section 13.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: OECD Guideline 202 Part II
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Two stock solutions were prepared (1600 mg/L; 200 mg/L). The substance was heated before the initial weight (approx. 50 °C). Stock solutions were renewed every second or third day and stored in refrigerator (approx. 4 °C).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain/clone: Straus 1820
- Source: In-house stock TTB-Ökologie, Henkel KGaA
- Feeding during test
- Food type: Scenedesmus subspicatus
- Amount: 0-7 days old species: 2.5*10^6 cells/daphnia/day / > 7 days old species: 5.0*10^6 cells/daphnia/day
- Frequency: every day
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
not stated
Test temperature:
21.7 - 22.0 °C
pH:
7.5 - 8.3 (control)
8.0 - 8.1 (highest test concentration)
Dissolved oxygen:
93-102%
Nominal and measured concentrations:
Nominal concentrations: 0, 1, 2, 4, 8, 16 mg/L
Measured concentrations for the nominal concentration of 2 mg/L: 2.1 mg/L (0 h); 1.9 mg/L (24 h) measured on day 6
Measured concentrations for the nominal concentration of 2 mg/L: 2.1 mg/L (0 h); 1.7 mg/L (24 h) measured on day 14
Measured concentrations for the nominal concentration of 2 mg/L: 1.9 mg/L (0 h); 1.8 mg/L (24 h) measured on day 21
Measured concentrations for the nominal concentration of 4 mg/L: 3.9 mg/L (0 h); 3.4 mg/L (24 h) measured on day 14
Measured concentrations for the nominal concentration of 4 mg/L: 3.8 mg/L (0 h); 3.6 mg/L (24 h) measured on day 21
Measured concentrations for the nominal concentration of 8 mg/L: 8.4 mg/L (0 h); 7.9 mg/L (24 h) measured on day 7
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL conical-flasks
- Type: slightly closed
- fill volume: 50 mL
- Renewal rate of test solution: every day
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-Elendt medium


OTHER TEST CONDITIONS
- Photoperiod: 16/8 h
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.76 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: recalculated from raw data
Reported statistics and error estimates:
A re-evaluation of the raw data has been conducted in order to obtain more reliable and robust ECx values instead of NOEC values. Recent scientific developments have led to a recommendation of abandoning the concept of NOEC and replacing it with regression based point estimates ECx.
A nonlinear regression using the 4-parameter logistic was performed on the raw data for mortality, using ToxRatStd Version 2.10@ software.
Parameters of the logistic equation: a = 96,33479, b = 23,54864, c = 3,86749, d = 0,00000. Sum of squared residuals: 80,66682.

Because of the good degradability of the substance the test setup was renewed every day. The species were transfered to new test vessels with renewed test solutions. The chemical analysis resulted in a recovery of the substance of more than 80%. Therefore, the nominal concentrations were used for the determination of the NOECs. The most sensitive endpoint for the substance was the mortality (NOEC: 2 mg/L (= 1 mg active matter/L); recalculated EC10: 3.52 mg/L (= 1.76 mg active matter/L)).

Results of the statistical re-evaluation:

EC10: 3.523 mg product/L, equivalent to 1.762 mg a.i./L

EC20: 3.646 mg product/L, equivalent to 1.823 mg a.i./L

EC10: 3.867 mg product/L, equivalent to 1.934 mg a.i./L

For details see attached statistical report.

Description of key information

EC10 (21 d) = 1.76 mg a.i./L (nominal) for Daphnia magna (OECD 202 part II); read across (CAS 110615-47-9)

Key value for chemical safety assessment

Additional information

No data are available on the long-term toxicity of D-Glucopyranose, oligomeric, undecyl glycoside (CAS 98283-67-1) to aquatic invertebrates. In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across was conducted to the structurally related category member substance D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9). The read across approach is justified in the overall summary (IUCLID Chapter 6.1) and in detail in the category justification document attached in IUCLID Section 13.

 

The long-term effects of D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) towards aquatic invertebrates were evaluated in a 21 d test with Daphnia magna, according to the OECD guideline 202 part II and GLP (Henkel KGaA, 1995). The test design was semi-static with a daily renewal of the test substance und growth medium. The test exhibited an EC10 value (21 d) of 1.76 mg a.i./L for the endpoint mortality and a NOEC (21 d) of 2 mg a.i./L for the endpoint reproduction.