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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Jun - 18 Jun 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 and 1000 mg/L

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution was prepared with dilution water. The final volume was 5 L. The test concentration was prepared by direct weighing of the test substance due to its insolubility. After mixing, the aquaria were treated with ultraturrax for approximately 10 seconds.
- Controls: 1
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: Fa. Westaquarium, delivered on 02 Mar 1993
- Feeding during test: not stated
- Food type: Altromin N-1324

ACCLIMATION
- Health during acclimation (any mortality observed): Mortality was < 0.1% one week before starting the test.

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21.2 - 22.9 °C
pH:
7.2 - 7.9
Dissolved oxygen:
68 - 93%
Nominal and measured concentrations:
nominal concentrations: 0; 100; 300; 1000; 3000; 10,000 mg/L
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: Aquaria, final volume 5 L
- Renewal rate of test solution (frequency/flow rate): Once every 24 hours the test solution was renewed.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Measurements of parameter for water quality were performed with WTW pH-91 (pH-value) and WTW Oxi-91 (dissolved oxygen).

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Mortality was determined at 0, 6, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 to 3.33
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: 0%
- No sublethal effects were observed.
- Effect concentrations exceeding solubility of substance in test medium: A slight foam formation was observed at 3000 mg/L at test start, at 10000 mg/L during the whole test duration. TOC analysis was not successful as test substance gathered at the surface despite treatment with ultraturrax.
Sublethal observations / clinical signs:

Table 1: Mortality (%) of Brachydanio rerio.

Conc. (mg/L)

Test time (hours)

0

6

24

48

72

96

0

0

0

0

0

0

0

100

0

0

0

0

0

0

300

0

0

0

0

0

0

1000

0

0

0

0

0

0

3000

0

0

0

0

0

0

10000

0

0

0

0

0

0

Table 2: Analytical results.

Nominal concentration of

Measured concentration after

mg

Product/L

mg

TOC/L

0 h

(14 Jun)

24 h

(15 Jun)

0 h

(16 Jun)

24 h

(17 Jun)

mg TOC/L

mg TOC/L

mg TOC/L

mg TOC/L

100

77.23

0.6

4.5

0.5

1.1

1000

772.30

1.8

11.6

1.4

4.8

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 - 23 Sep 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Annex of 92/69/EWG
Deviations:
yes
Remarks:
- only 4 test concentrations, temperature deviates more than +/- 1 °C but the temperature was in the proposed optimal range for the zebrafish
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solutions (100 µg/mL, volume 100 mL) were prepared in drinking water and stired for 30 minutes with a magnetic stirrer
- Controls: drinking water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Westaquarium (deliveration date: 1994-08-30); no pre-treatment

ACCLIMATION
- Health during acclimation (any mortality observed): < 0.1% one week before the test was performed
- Food type: Altromin 1324 (Charge 041294/0843)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
not stated
Test temperature:
22.0 - 24.3 °C
pH:
7.8 - 8.2
Dissolved oxygen:
69 - 89%
Nominal and measured concentrations:
Nominal concentrations: control, 2, 4, 8, 16 mg/L
Measured concentrations for the nominal concentraiton of 2 mg/L: 1.8 (day 1, 0 h), 1.7 (day 2, 24 h), 2.7 (day 3, 0 h), 3.6 (day 4, 24 h) mg/L
Measured concentrations for the nominal concentration of 8 mg/L: 7.5 (day 1, 0 h), 7.0 (day 2, 24 h), 7.3 (day 3, 0 h), 7.5 (day 4, 24 h) mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Fill volume: 5 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


EFFECT PARAMETERS MEASURED: the mortality was observed every day


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.95 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
5.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: unbalancing was observed at 8 mg/L after 24 h
- Mortality of control: 0%
Reported statistics and error estimates:
Determination of the EC50 with similogarithmic inter- and extrapolation with EC0/EC100.
Sublethal observations / clinical signs:

The test resulted in a LC0 of 4 mg/L (= 2 mg active matter/L), a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) and a LC100 of 16 mg/L (= 8 mg active matter/L) after 96 hours.

Endpoint:
short-term toxicity to fish
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 hypothe sis 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:
96 h
Dose descriptor:
LC50
Effect conc.:
2.95 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: effect concentration based on analytically verified nominal concentrations
Sublethal observations / clinical signs:

Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300061, 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 (>10000mg/l) is reduced to 30%: EC50>3000mg/l

2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)

The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.

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: fish acute 96-LC50 = 2.95mg/L

Conclusions:
Test results from two read-across substances arte considered:

1: (key, Henkel, 1993, R9300061, 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 (>10000mg/l) is reduced to 30%: EC50>3000mg/l


2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)
The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.

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: fish acute 96-LC50 = 2.95mg/L

Description of key information

Test results from two read-across substances are considered:

1: (key, Henkel, 1993, R9300061, 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 (>10000mg/l) is reduced to 30%: EC50>3000mg/l

2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)

The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.

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: fish acute 96-LC50 = 2.95mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
2.95 mg/L

Additional information