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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:
weight of evidence
Study period:
18. July - 22. July 1988
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)
Deviations:
yes
Remarks:
only 3 concentrations tested
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance was directly weighed into the test vessels, filled up to final volume of 5 L with standard dilution water and afterwards stirred 10 seconds by Ultraturrax.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Feeding during test: none


ACCLIMATION
- Health during acclimation: Mortality prior to test < 0.1%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
about 250 mg CaCO3/L
Test temperature:
22.5 - 23.5°C
pH:
7.5 - 8.0
Dissolved oxygen:
oxygen saturated (60-98%)
Nominal and measured concentrations:
Nominal concentrations: 1000, 3000 and 10000 mg/L
No measured concentrations even though test substance poorly water soluble.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10L fish basins containing 5L test water
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


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


OTHER TEST CONDITIONS
- Photoperiod: 16 hours illumination per day


EFFECT PARAMETERS MEASURED: Mortality, recorded at 0, 6, 24, 48, 72 and 96 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3
- Justification for using less concentrations than requested by guideline: no
Reference substance (positive control):
no
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)
Remarks on result:
other: No effect up to the limit of the water solubility of the test substance was observed.
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)
Remarks on result:
other: No effect up to the limit of the water solubility of the test substance was observed.
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: No effect up to the limit of the water solubility of the test substance was observed.
Details on results:
- Behavioural abnormalities: The fish did not show any abnormal behaviour.
- Mortality of control: no
- Effect concentrations exceeding solubility of substance in test medium: Yes, but it is not mentioned that precipitation was observed.
Sublethal observations / clinical signs:

No effect up to the limit of the water solubility of the test substance was observed.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
22. April - 26. April 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no data on number of fish, only two concentrations tested, no analytics).
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)
Deviations:
yes
Remarks:
, only two concentrations tested
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples were taken at 0 and after 24 hours for the test solution with 3000 mg/L test substance.
Vehicle:
no
Details on test solutions:
As the test substance is poorly water soluble, it was weighed directly into the test vessels and mixed for 10 seconds with Ultraturrax.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: Fa. Westaquarium, from 07.12.1990


ACCLIMATION
- Type and amount of food: Altromin 1413, specification of A 1410, identically with A 1413 but rough pellets instead of grinded.
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
96 h
Test temperature:
22.5 - 23.5°C
pH:
7.8 - 8.2 (measured every 24h)
Dissolved oxygen:
O2-Values (%): 63 (96h) - 98 (0h) (measured with WTW Oxi-91)
Nominal and measured concentrations:
Nominal concentrations: 0, 3000, 10000 mg/L
Measured concentrations: The test solution with 3000 mg/L was measured after 0 and 24 hours: 2813 mg/L CSB (0 h) and 313 mg/L CSB (24h)
Details on test conditions:
TEST SYSTEM
- Test vessel: test basins
- Renewal rate of test solution: semistatic, but renewal intervals not mentioned
- Intervals of water quality measurement: after 0, 24, 48, 72 and 96 hours


EFFECT PARAMETERS MEASURED: mortality after 6, 24, 48, 72 and 96 hours
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)
Remarks on result:
other: No mortality up to the limit of the water solubility was observed.
Details on results:
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Yes, after 24 hours only 313 mg/L CSB was measured in the 3000 mg/L test solution (2813 mg/L CSB was measured at 0h). It is mentioned that the 24 hour value is not describing the real relationships, as a phase separation was observed and no representative sample could be taken.
- Effect concentrations exceeding solubility of substance in test medium: Yes. LC values based on nominal values even though concentrations were clearly higher than water solubility of test substance. It can be stated, that no toxicity was observed up to the limit of the water solubility of the test substance under conditions tested.
Sublethal observations / clinical signs:

No toxicity was observed up to the limit of the water solubility of the test substance under conditions tested.

Table 1: Mortality [%]

Concentration

[mg/L]

Test duration [h]

0

6

24

48

72

96

0

0

0

0

0

0

0

3000

0

0

0

0

0

0

10000

0

0

0

0

0

0

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
05-09 May 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no GLP, only three concentrations tested, no analytics).
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)
Deviations:
yes
Remarks:
, only three concentrations tested
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Nominal and measured concentrations:
Nominal concentrations: 100, 1000, 10000 mg/L
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)
Remarks on result:
other: No mortality was observed up to the limit of the water solubility of the test substance.
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)
Remarks on result:
other: No mortality was observed up to the limit of the water solubility of the test substance.
Sublethal observations / clinical signs:

No toxicity of the test substance was observed up to the limit of the water solubility under semistatic conditions tested.

Table 1: Mortality [%]

Concentration

[mg/L]

Incubation time [h]

0

6

24

48

72

96

100

0

0

0

0

n.d

0

1000

0

0

0

10

n.d.

10

10000

0

0

0

0

n.d.

0

n.d. = not determined

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
31 Jan- 4 Feb 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: The concentration of the Water Accommodated Fraction was analysed
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution with 1 g/L test substance in drinking water was prepared. It was stirred for approx. 18h and afterwards filtrated. The filtrated solution (Water Accommodated Fraction - WAF) was used as test solution and prepared daily
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Source: West Aquarium, Bad Leuterberg
- Length at study initiation: 3 ± 0.5 cm
- Feeding during test: none


ACCLIMATION
- Acclimation period: The fish were treated with Malachitgreen three times a week and were in quarantine for 14 days before being used in tests.
- Type and amount of food: TetraMin (1% of bodyweight)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): The fish were free of obvious illnesses. The mortality was 7 days before the start of the test < 5%.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
approx. 13 °dH
Test temperature:
20 ± 1 °C
pH:
7.3 - 8.3
Dissolved oxygen:
69 to 107% O2 saturation
Nominal and measured concentrations:
Preparation of Water Accommodated Fractions (WAF): Mean of measured concentrations is 53 mg/L (DOC measured)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 30 L aquaria filled with 9 L
- Aeration: continuous
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: approx. 0.14g fish/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from "Gelsenwasser AG"


OTHER TEST CONDITIONS
- Photoperiod: 16 h

EFFECT PARAMETERS MEASURED: mortality at 24, 48, 72 and 96 hours


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: As substance is poorly water soluble, the test substance was only tested at water soluble concentration (WAF)
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 53 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Measured concentrations ranged from 17 to 104 mg/L in freshly prepared test solutions (based on measured DOC).
Details on results:
- Mortality of control: 1 out of 10
- Effect concentrations exceeding solubility of substance in test medium: No, as Water Accommodated Fractions were prepared
Sublethal observations / clinical signs:

No toxicity of the test substance up to the limit of the water solubility under test conditions was observed.

WAF were prepared, but measured concentrations ranged from 17 to 104 mg/L in freshly prepared test solutions (based on measured DOC).

Table 2: Number of surviving and dead individuals during the test (absolute numbers and % values)

Concentration

(mg/L)

Test period

24

48

72

96

Number

%

Number

%

Number

%

Number

%

alive

dead

alive

alive

dead

alive

alive

dead

alive

alive

dead

alive

Control

10

0

0

10

0

0

10

0

0

9

1

10

WAF

10

0

0

10

0

0

10

0

0

10

0

0

 

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
22.-26. May 1989
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)
Deviations:
yes
Remarks:
, only three concentrations tested
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct weight of the test substance in to the test vessels, filled up to final volumes of 5 L with standard dilution water and stirred 5 minutes by Ultraturrax.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Feeding during test: none

ACCLIMATION
- Health during acclimation: Mortality prior to test < 0.1%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
about 250 mg CaCO3/L
Test temperature:
22.5-23.5°C
pH:
7.8 +/- 0.2
Dissolved oxygen:
Oxygen saturated (68-97%)
Nominal and measured concentrations:
Nominal concentration: 1000, 3000, 10000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10 L fish basins containing 5 L test water
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


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


OTHER TEST CONDITIONS
- Photoperiod: about 16h


EFFECT PARAMETERS MEASURED: Mortality, recorded at 0, 6, 24, 48, 72 and 96 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: >= 3
Reference substance (positive control):
no
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)
Remarks on result:
other: No effect up to the limit of the water solubility of the test substance was observed.
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)
Remarks on result:
other: No effect up to the limit of the water solubility of the test substance was observed.
Details on results:
- Mortality of control: none
- Any observations that might cause a difference between measured and nominal values: not mentioned
- Effect concentrations exceeding solubility of substance in test medium: yes
Sublethal observations / clinical signs:

No mortality up to the limit of the water solubility of the test substance observed under test conditions. The fish did not show any abnormal behaviour.

Mortality [%]

Concentration

[mg product/L]

Incubation time [h]

0

6

24

48

72

96

1000

0

0

0

0

0

0

3000

0

0

0

0

0

0

10000

0

0

0

0

0

0

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
refer to category justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
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)
Remarks on result:
other: RA CAS 67701-33-1a
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)
Remarks on result:
other: RA CAS 67701-33-1b
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 53 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: RA CAS 73398-61-5
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)
Remarks on result:
other: RA CAS 8001-78-3
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)
Remarks on result:
other: RA CAS 67701-30-8

Description of key information

No effect on fish up to the limit of the water solubility of the category members Fatty Acid Glycerides was observed.

Key value for chemical safety assessment

Additional information

The hazard assessment is based on the data currently available. New studies (including long-term studies) with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

 

In order to fulfil the standard information requirements, according to Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

Five short-term studies with freshwater fish are available for four different substances (CAS No. 67701-33-1, 73398-61-5, 8001-78-3, 67701-30-8). In all five semi-static studies over 96 hours with Danio rerio no effect up to the limit of the water solubility of the test substances was observed.

Four tests were conducted according to ISO 7346-1 Part 2 under semi-static conditions. In these tests the test substance was directly weighed into the test vessels and undissolved test substance was not removed. The fifth study (CAS No. 73398-61-5; Scholz 1994) was conducted according to the EU-method C.1, which is equivalent to OECD guideline 203. For this limit test water accommodated fractions (WAF) were prepared by filtration of the test solution. In the freshly prepared test solutions the DOC was measured. The result (LC0 ~ 53 mg/L) was based on the mean concentration of these measurements which were varying from 17 to 104 mg/L. As the water solubility of the test substance is < 1 mg/L no complete separation of the test substance was achieved.

Thus, no effect on fish up to the limit of the water solubility for all category members Fatty Acid Glycerides is assumed.