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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 Jul - 16 Jul 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: National guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: DIN 38412 part 11
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 300 and 1000 mg/L

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test concentration was prepared by direct weighing of the test substance into synthetic water due to its insolubility. After mixing, the test substance was treated with ultrasound for approximately 1 minute.
- Controls: 2
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: identical with the strain of BGA WaBoLu
- Source: own breeding (Henkel KGaA, TFB Ökologie)
- Age at study initiation: 6 to 24 hours
- Food type: green algae (Chlorella kessleri)


Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20 - 21 °C
pH:
7.6 - 8.4
Dissolved oxygen:
78 - 115% at 0 - 3000 mg/L, 20% at 10000 mg/L after 48 h
Nominal and measured concentrations:
nominal concentrations: 0; 100; 300; 1000; 3000; 10,000 mg/L
Details on test conditions:
TEST SYSTEM
- Aeration: no additional aeration
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic water
- Intervals of water quality measurement: Measurements of O2 and pH were conducted after 48 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 to 3.33
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
3 160 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Mortality in control < 10%. Effect concentrations exceeding solubility of substance in test medium. Increasing test concentrations led to higher occurence of undissolved particles of test substance at the surface of the test medium. Therefore, it is suggested that the air supply was reduced depending on the test substance concentration. The oxygen saturation was only 20% at a concentration of 10,000 mg/L which may explain the immobility of all test organisms. TOC-Analytics was not applicable for the test substance. But the chosen DOC-Analytics was also not suitable to investigate the test substance.
Results with reference substance (positive control):
Effect of the reference substance was not determined due to narrow interval of the tested concentrations.

Table 1: Analytical results.

Nominal concentration of

Measured concentration after

mg

Product/L

mg

DOC/L

0 h

(14 Jun)

24 h

(15 Jun)

48 h

(16 Jun)

mg DOC/L

mg DOC/L

mg DOC/L

300

1.9

3.1

2.1

1.5

1000

6.4

6.3

3.1

3.6

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
15 - 18 May 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: ISO 14669 (1999) Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda: Crustacea); ISO 5667-16 (1998) Water Quality sampling - Guidance on biotesting of samples
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water-accommodated fraction (WAF) in UV-sterilised and filtered to 0.2 µm seawater
Test organisms (species):
other aquatic crustacea: Acartia tonsa
Details on test organisms:
TEST ORGANISM
- Strain: T10
- Age at study initiation: 19 days
- Feeding during test
- Food type: algal diet
Test type:
not specified
Water media type:
saltwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
not stated
Test temperature:
18.9 - 21.1 °C
pH:
7.94 - 8.29
Dissolved oxygen:
96 - 98%
Nominal and measured concentrations:
Nominal concentrations: control, 1.0, 1.8, 3.2, 5.6, 10 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL borosilicate glass crystallising dishes
- Type: slightly covered with soda glass watch covers
- fill volume: 50 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural seawater

OTHER TEST CONDITIONS
- Adjustment of pH: 1M HCl or 1M NaOH

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Range finding study
- Test concentrations: 1, 10, 100, 1000 mg/L
Reference substance (positive control):
yes
Remarks:
3,5 Dichlorophenol
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
6.25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 4.14 - 9.43 mg/L
Duration:
48 h
Dose descriptor:
other: LC90
Effect conc.:
7.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: 0%
Results with reference substance (positive control):
48 h LC50: 0.86 mg/L (95% CL: 0.73 - 1.03 mg/L)
Reported statistics and error estimates:
LC50 values were calculated from the propotional response data using the moving average angle method (USEPA, 1985) or an appropriate method from the ToxCalc Version 5 package.

All the guideline criteria and values were fulfilled. The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48 h.

No chemical analysis was performed.

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:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: D-Glucopyranose monomers and oligomers and fatty alcohols C16 / C18 linear
• the metabolism pathway leads to comparable products (Glucose and glucose oligomers) and non-common products predicted to have no toxicological effects (long chain fatty alcohols).

Therefore, read-across from the existing acute toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached justification

3. ANALOGUE APPROACH JUSTIFICATION
see attached justification

4. DATA MATRIX
see attached justification

Justification attached at chap. 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
6.25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Conclusions:
Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300128, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
30% of test material consists of the target substance;
accordingly the EC50 of the original test material (3150 mg/l) is reduced to 30%: EC50>945mg/l


2. (supporting, BASF, 2001a, BPCN, R0100640-11, RL2) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides)
The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48h.

The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.

As a worst case approach, the lowest LC50 is used: daphnia acute 96-LC50 = 6.25mg/L

Description of key information

Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300128, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols

30% of test material consists of the target substance;

accordingly the EC50 of the original test material (3150 mg/l) is reduced to 30%: EC50>945mg/l

2. (supporting, BASF, 2001a, BPCN, R0100640-11, RL2) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides)

The LC50 was at 6.25 mg/L (48 h). No effects were observed at 1.8 mg/L after 48h.

The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.

As a worst case approach, the lowest LC50 is used: daphnia acute 96-LC50 = 6.25mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
6.25 mg/L

Additional information