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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:
January - July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
adopted 04. April 1984
Deviations:
no
Qualifier:
according to
Guideline:
other: EG-Guideline C.l. Akute Toxizitat fur Fische Richtlinie 84/449/EWG
Version / remarks:
Richtlinie der (Commission vom 25. April 1984 zur sechsten Anpassung der Richtlinie 67/548/EWG des Rates zur Angleichung der Rechts- und Verwaltungsvorschriften fur die Einstufung, Verpackung lind Kennzeichnung gefahrlicher Stoffe an den technischen Fortschritt
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Purity: ca. 94 %
Batch: T16 from 12/07/91
Analytical monitoring:
yes
Details on sampling:
Sampling method: With a pipette 20 mL were sampled in the middle of the tank
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
The test substance was diluted with dilutionwater, homogenised with a ultrasonic bath and Ultra-Turrax. In the tank the solution was stirred for 2 hours with a KPG-stirrer.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Strain: HAMILTON-BUCHANAN
- Source:Eigenzucht, HOECHST AG, Kastengrund
- Length at study initiation: range: 1.8 - 3.5 cm; mean: 3.2 cm
- Weight at study initiation: not available

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test conditions
- Type and amount of food during acclimation: Tetra Min, Tetra Werke, Melle
- Feeding frequency during acclimation: twice a day
- Health during acclimation: no mortality observed
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
22 ± 1 °C
pH:
7.7 - 8.1
Dissolved oxygen:
6.9 - 8.6 mg/L
Nominal and measured concentrations:
Nominal conentration: 500 mg/L
measured concentration: 520.7 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass tank in water bath
- Material, fill volume, size: glass, 10L, 30cm x 22cm x 24cm
- Aeration: yes
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1 g fish/L water

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: Following ISO/DIS 7346/1

OTHER TEST CONDITIONS
- Adjustment of pH: yes, with 10M NaOH
- Photoperiod: 12 h light, 12 h dark
- Light intensity: ca 700 Lux

EFFECT PARAMETERS MEASURED
Mortality, ability to swim, breathing and water quality paramers were recorded after 2-4, 24, 48, 72 and 96 hours.

Pretest: yes, but no details availabe
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no abnormalities
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Sampling date

1992-01-27

1992-01-29

1992-01-31

Geometric mean measured concentration [mg/L]

Nominal concentration

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Control

<1.0

 

<1.0

 

<1.0

 

 

500 mg/L

503

100.6

536

107.2

523

104.6

520.6

Meas. conc. = Measured concentration of the test item, enrichment and dilution factor taken into account

% = Percent of nominal concentration of test item

Geometric mean measured test item concentrations [mg/L]

Observation*

Number of fish effected after different exposure periods [hours]

2-4

24

48

72

96

500

 

H

s

s

0

0

0

Sw

s

a

s

0

0

O

0

s

s

0

0

N

0

0

0

a

a

Control

N

a

a

a

a

a

*The letters correspond to the following observations:

H = high activity

Sw = Swimming at bottom of tank

O = open gill lids

N = Normal behavior

s = some

a = all

Validity criteria fulfilled:
yes
Conclusions:
In this study the test item was found to cause no lethal effects to zebrafish after 96 hours at a concentration of 500 mg test item/L. The LC50 after 96 hours was > 500 mg test item/L.
Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (1984) and EG Guideline C.1 (1984) in January 1992. An acute toxicity test under static conditions was conducted with the nominal test item concentration of 500.0 mg/L. Duration of the test was 96 hours. Ten test organisms were exposed to the test concentration and the control. Water quality parameters (temperature, pH-value and oxygen- saturation) measured at 2 -4, 24, 48, 72 and 96 hours were determined to be within the acceptable limits. The determination of the test concentrations was carried out via IC. Evaluation was carried out from the media after 0, 48 and 96 h. The measured concentration was 520.6 mg/L, less than 20% above the nominal concentration. Therefore, all effect values are based on nominal concentrations. All validity criteria of the test guideline were met. The LC50 was determined to be > 500 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
October - Dezember 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
Adopted: July 17,1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Dated 07/31/1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Technical grade, purity: approx. 70 %
Batch: H2/95 from 08/10/95
Analytical monitoring:
yes
Details on sampling:
- Sampling method: water samples were taken from the middle of the test chamber by pipetting approx. 20 mL into a screw-neck glass bottle at study start, and after 48 and 96 hours
Vehicle:
no
Details on test solutions:
The test substance was weighed into a beaker. Water for dilution was added and the mixture homogenized using an Ultra-Turrax and ultrasonic bath and poured into the chamber under stirring with a glass rod.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: HAMILTON-BUCHANAN
- Source: Corporate Toxicology Hoechst AG, Kastengrund
- Length at study initiation: 3.1 - 3.5 cm, mean 3.3 cm

ACCLIMATION
- Acclimation period: yes, 12 days
- Acclimation conditions: same as test conditions
- Type and amount of food during acclimation: Tetra Min, Tetra Werke, Melie (FRG)
- Feeding frequency during acclimation: twice daily ad libitum
- Health during acclimation: no mortality observed

FEEDING DURING TEST: no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
21.3 - 21.8 °C
pH:
7.7 - 8.3
Dissolved oxygen:
7.0 - 9.9 mg/L
Nominal and measured concentrations:
Nominal concentration: 1000 mg/L
Measured concentration: 999.7 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: test chambers
- Material, size, fill volume: glass, length 30 cm, width 22 cm, height 24 cm, 10L
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: Reconstituted water, composition according to ISO/DIS 7346/1
- Total hardness: 2.1 mmol Ca2+ + Mg2+ / L

OTHER TEST CONDITIONS
- Adjustment of pH: yes, with 10M NaOH
- Photoperiod: from 06.00 a.m to 06.00 p.m
- Light intensity: approximately 700 lux

EFFECT PARAMETERS MEASURED
after 3, 6, 24, 48, 72 and 96 hours: lethality and visible changes in appearance and behavior
after 0, 24, 48, 72 and 96 hours: water parameters

TEST CONCENTRATIONS
- Range finding study: yes, no details available
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Sampling date

1995 -11 -20

1995 -11 -22

1995 -11 -24

Geometric mean measured concentration [mg/L]

Nominal concentration

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Control

<1.0

 

<1.0

 

<1.0

 

 

1000 mg/L

1000

100

999

99.9

1000

100

999.7

Meas. conc. = Measured concentration of the test item, enrichment and dilution factor taken into account

% = Percent of nominal concentration of test item

Geometric mean measured test item concentrations [mg/L]

Observation*

Number of fish effected after different exposure periods [hours]

3 -6

24

48

72

96

1000

 

P

s

0

0

0

0

Sw

s

0

0

0

0

D

0

s

0

0

0

N

0

0

a

a

a

Control

N

a

a

a

a

a

*The letters correspond to the following observations:

P = projecting opercula

Sw = Swimming posture tail-heavy

D = decreased respiration rate

N = Normal behavior

s = some

a = all

Validity criteria fulfilled:
yes
Conclusions:
In this study the test item was found to cause no lethal effects to zebrafish after 96 hours at a concentration of 1000 mg test item/L. The LC50 after 96 hours was > 1000 mg test item/L.
Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (1992) and EG Guideline C.1 (1992) in November 1995. An acute toxicity test under static conditions was conducted with the nominal test item concentration of 1000.0 mg/L. Duration of the test was 96 hours. Seven test organisms were exposed to the test concentration and the control. Water quality parameters (temperature, pH-value and oxygen- saturation) measured at 0, 24, 48, 72 and 96 hours were determined to be within the acceptable limits. The determination of the test concentrations was carried out via spectrophotometrical detection. Evaluation was carried out from the media after 0, 48 and 96 h. The measured concentration was 999.6 mg/L, less than 20% below the nominal concentration. Therefore, all effect values are based on nominal concentrations. All validity criteria of the test guideline were met. The LC50 was determined to be > 1000 mg/L.

Description of key information

In a key study the pure test item was found to cause no lethal effects to zebrafish after 96 hours at a concentration of 500 mg test item/L. The LC50 after 96 hours was determined to be > 500 mg test item/L.

In a supporting study the technical grade test item was found to cause no lethal effects to zebrafish after 96 hours at a concentration of 1000 mg test item/L. The LC50 after 96 hours was determiend to be > 1000 mg test item/L.

In conclusion, the LC50 of the test item is considered to be >500 mg/L, as this value was considered more accured because it was determined for the pure substance.

Key value for chemical safety assessment

Additional information

The acute toxicity of the pure test item to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (1984) and EG Guideline C.1 (1984) in January 1992. An acute toxicity test under static conditions was conducted with the nominal test item concentration of 500.0 mg/L. Duration of the test was 96 hours. Ten test organisms were exposed to the test concentration and the control. Water quality parameters (temperature, pH-value and oxygen- saturation) measured at 2-4, 24, 48, 72 and 96 hours were determined to be within the acceptable limits. The determination of the test concentrations was carried out via IC. Evaluation was carried out from the media after 0, 48 and 96 h. The measured concentration was 520.6 mg/L, less than 20% above the nominal concentration. Therefore, all effect values are based on nominal concentrations. All validity criteria of the test guideline were met. The LC50 was determined to be > 500 mg/L.

In a supporting study, the acute toxicity of the technical test item to fish (zebrafish) was determined according to the principles of the OECD Guideline for Testing of Chemicals No. 203 (1992) and EG Guideline C.1 (1992) in November 1995. An acute toxicity test under static conditions was conducted with the nominal test item concentration of 1000.0 mg/L. Duration of the test was 96 hours. Seven test organisms were exposed to the test concentration and the control. Water quality parameters (temperature, pH-value and oxygen- saturation) measured at 0, 24, 48, 72 and 96 hours were determined to be within the acceptable limits. The determination of the test concentrations was carried out via spectrophotometrical detection. Evaluation was carried out from the media after 0, 48 and 96 h. The measured concentration was 999.6 mg/L, less than 20% below the nominal concentration. Therefore, all effect values are based on nominal concentrations. All validity criteria of the test guideline were met. The LC50 was determined to be > 1000 mg/L.