Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From March 19, 1976 to March 26, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
No analytical verification of test concentrations
Principles of method if other than guideline:
Golden orfe (Leuciscus idus melanotus) were acclimated for at least 14 days before test begin. The animals were fed during the acclimation period but not during the study. Approximately 65 h before test begin, 10 fish/group were placed in the respective glass aquaria (40 x 25 x 30 cm) filled with 20 L of water and aerated at a rate of 120 ml/min. The test medium was deionised water containing 30 mg/L MgSO4, 48 mg/L Na2CO3, 3 mg/L KCl and 38 mg/L CaSO4.2H2O. The test substance, in the form of a yellow-brown viscous liquid, was dispersed in the test medium at nominal concentrations of 0, 10, 100 and 500 mg/L. Fish were observed daily for mortality and clinical signs during 96 h. Oxygen, pH and temperature were monitored daily. At the end of the study, all fish were sacrificed, dissected and macroscopically evaluated.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Leuciscus idus melanotus
Details on test organisms:
Body weight and length 1.0-3.6 g and 5.2-6.9 cm, respectively.
10 animals per dose
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
20.0 +/- 0.5°C
pH:
7.20 - 7.95
Dissolved oxygen:
7.30 - 8.40 mg/L
Nominal and measured concentrations:
Nominal: 0, 10, 100 and 500 mg/L, equivalent to 0, 3.3, 33 and 165 mg a.i./L based on a 33% test substance purity
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 (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 165 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
33% test substance purity
Basis for effect:
mortality (fish)
Details on results:
There was no mortality during the study and no behavioural abnormalities were noted.
At 100 and 500 mg/L (33 and 165 mg a.i./L), an orange-brown discoloration of the bile and yellowish liquid were observed in the gastrointestinal tract. There were no findings in the other dose groups.
Validity criteria fulfilled:
not applicable
Conclusions:
Under the study conditions, the 96h LC50 of the test substance to golden orfe (Leuciscus idus f. melanotus) was determined to be > 500 mg/L, equivalent to > 165 mg a.i./L.
Executive summary:

A study was conducted to determine the toxicity of the test substance (in the form of a water soluble yellow-brown viscous liquid of 33% purity) to Golden orfe (Leuciscus idus melanotus). After acclimation, 10 fish/group were exposed to the substance dispersed in test medium at nominal concentrations of 0, 10, 100 and 500 mg/L (equivalent to 0, 3.3, 33 and 165 mg a.i./L). The animals were observed daily for mortality and clinical signs during 96 h. Oxygen, pH and temperature were monitored daily. At the end of the study, all fish were sacrificed, dissected and macroscopically evaluated. No analytical validation of test concentrations was conducted. There was no mortality during the study and no behavioural abnormalities were noted. At 100 and 500 mg/L (33 and 165 mg a.i./L), an orange-brown discoloration of the bile and yellowish liquid were observed in the gastrointestinal tract. There were no findings in the other dose groups. Under the study conditions, the nominal 96 h LC50 was determined to be > 500 mg/L, equivalent to > 165 mg a.i./L (Markert, 1976). The study was repeated under the same conditions in 1977 and similar results were obtained (Report 521/77, Markert, 1977).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 12, 1990 to February 16, 1990 and from March 12, 1990 to March 16, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical verification of test concentrations
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Remarks:
water
Details on test solutions:
The test substance was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Supplier/Breeder: West aquarium GmbH U. Co. KG
Body length and weight: 2.4-3.0 cm and 0.12-0.26 g, respectively. Loading: 0.34 g fish/L
Acclimatation: 1 week
Photoperiod: 16h light and 8h dark
Diet: "tetra min" std feed for aquarium fish, ad libitum
Test type:
flow-through
Water media type:
freshwater
Remarks:
slight continuous aeration
Total exposure duration:
96 h
Hardness:
ca. 2.5 mmol/L
Test temperature:
21 +/- 1°C
pH:
ca. 8.0
Dissolved oxygen:
> 60% of maximum saturation
Salinity:
The resalting was carried out by addition of:
- 294.0 mg/L CaCl2.2H2O, 123.3 mg/L MgSO4.7H2O, 63.0 mg/L NaHCO3, and 5.5 mg/L KCl
Nominal and measured concentrations:
Nominal: 0, 1000, 1800, 3200 and 5000 mg/L, equivalent to 0, 200, 360, 640 and 1000 mg a.i./L based on a purity of 20%
Details on test conditions:
Based on the results of 2 range finding studies
10 fishes per condition
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2 364 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.:
473 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
20% test substance purity
Duration:
96 h
Dose descriptor:
other: LC5
Effect conc.:
1 128 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: LC5: 226 mg/L (a.i.)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
4 956 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: LC100: 991 mg/L (a.i.)
Details on results:
No symptoms were observed at any time and concentration tested.
Exposure to the test substance at concentrations of 1800, 3200 and 5000 mg/L induced mortality after 72 and 96h (all fish died at the concentration 5000 mg/L after 96 h of exposure).
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 96 h LC5, 50 and 100 of the test substance to Zebra fish (Brachydanio rerio) were determined to be 1128, 2364 and 4956 mg/L (nominal), respectively (corresponding to 225.6, 472.8 and 991.2 mg a.i./L).
Executive summary:

A study was conducted to determine the toxicity of the test substance (in the form of a water soluble liquid dispersion of 20% purity) to Zebra fish (Brachydanio rerio) according to OECD Guideline 203. The fish were exposed for 96 h to nominal concentrations of 0, 1000, 1800, 3200 and 5000 mg/L (equivalent to 0, 200, 360, 640 and 1000 mg a.i./L). Mortality and symptoms were assessed daily. No analytical verification of test concentrations was conducted. There were no symptoms observed in any group. Exposure at 1800, 3200 and 5000 mg/L induced mortality after 72 and 96 h. Under the study conditions, the nominal 96 h LC5, 50 and 100 were determined to be 1128, 2364 and 4956 mg/L, respectively (corresponding to 226, 473 and 991 mg a.i./L) (Munk, 1990).

Description of key information

Key value for chemical safety assessment:

LC50 for freshwater fish: 473.0 mg a.i./L

LC50 for marine fish: -

Key value for chemical safety assessment

Additional information

A study was conducted to determine the toxicity of the test substance (in the form of a water soluble liquid dispersion of 20% purity) to Zebra fish (Brachydanio rerio) according to OECD Guideline 203. The fish were exposed for 96 h to nominal concentrations of 0, 1000, 1800, 3200 and 5000 mg/L (equivalent to 0, 200, 360, 640 and 1000 mg a.i./L). Mortality and symptoms were assessed daily. No analytical verification of test concentrations was conducted. There were no symptoms observed in any group. Exposure at 1800, 3200 and 5000 mg/L induced mortality after 72 and 96 h. Under the study conditions, the nominal 96 h LC5, 50 and 100 were determined to be 1128, 2364 and 4956 mg/L, respectively (corresponding to 226, 473 and 991 mg a.i./L) (Munk, 1990).

A study was conducted to determine the toxicity of the test substance (in the form of a water soluble yellow-brown viscous liquid of 33% purity) to Golden orfe (Leuciscus idus melanotus). After acclimation, 10 fish/group were exposed to the substance dispersed in test medium at nominal concentrations of 0, 10, 100 and 500 mg/L (equivalent to 0, 3.3, 33 and 165 mg a.i./L). The animals were observed daily for mortality and clinical signs during 96 h. Oxygen, pH and temperature were monitored daily. At the end of the study, all fish were sacrificed, dissected and macroscopically evaluated. No analytical validation of test concentrations was conducted. There was no mortality during the study and no behavioural abnormalities were noted. At 100 and 500 mg/L (33 and 165 mg a.i./L), an orange-brown discoloration of the bile and yellowish liquid were observed in the gastrointestinal tract. There were no findings in the other dose groups. Under the study conditions, the nominal 96 h LC50 was determined to be > 500 mg/L, equivalent to > 165 mg a.i./L (Markert, 1976). The study was repeated under the same conditions in 1977 and similar results were obtained (Report 521/77, Markert, 1977; results not shown).