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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Oct. 11, 1999 to Nov. 22, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Daily analysis of the only test concentration plus a control samples
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method of administration: Direct weighing
- Water for dilution: Synthetic fresh water in accordance with ISO.

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Gold fish
- Strain: HAMILTON BUCHANAN
- Source: Bio International B.V. (Netherlands)
- Age at study initiation (mean and range, SD): ~ 10 mo
- Length at study initiation (length definition, mean, range and SD): 2.5-3.5 cm

ACCLIMATION
- Acclimation conditions (same as test or not): Yes
- Keeping water: Synthetic fresh water in accordance with ISO
- Mortality: <2 % while kept
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No
Hardness:
14.1 °dH

Test temperature:
21-21.5 °C

pH:
7.7-8.1
Dissolved oxygen:
8.5-8.7 mg/L
Oxygen [% saturation]=96.9-100.2
Nominal and measured concentrations:
Nominal: 0 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Test vessels (300 x 135 x 200 mm)
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: 5 L test medium
- Aeration: Yes
- Type of flow-through (e.g. peristaltic or proportional diluter): Static
- Method of administration: Direct weighing


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic fresh water in accordance with ISO

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, visible effects on appearance and behaviour

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 100 mg/L
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 103.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 67.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: No effects
- Observations on body length and weight:
- Other biological observations: No effects
- Mortality of control: Nil
- Fresh weight (g) of 10 fishes: 4.97 and 4.36 for control and test group animals
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No data
Sublethal observations / clinical signs:

Table 1. Results-Analysis

Nominal

concentration

test substance

[mg/L]

Analytical dates

(mg/L)

0 h

24 h

48 h

72 h

96 h

Control

< 2

< 2

< 2

< 2

< 2

100

24

24

24

24

24

 

The above test result refers to a concentration of the test substance which was calculated directly from analytically determined TOC values. According to the relevant product information, 1 mg/L TOC equals to 2.8 mg/L of the organic components of the test substance (structural formula: C23H21CIN6014S4; molecular weight 769.16 g/mol (free acid).

As these organic components correspond to 65 % of the molecular weight of the test substance, 100 mg/L of the test Substance equals to 23 mg/L of organic C. Thus, the above analytical values indicate a very good recovery rate.

 

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h LC0 value of the test substance was determined to be ≥103.4 mg/L.
Executive summary:

A study was performed to assess the acute toxicity of test substance to Zebra fish (Brachydanio rerio)under static conditions. The study was conducted in accordance with EU Method C.1. in compliance with GLP.

 

Groups of ten fish of the recommended size were exposed to a limit test concentration of nominally 100 mg/L of test substance dissolved in synthetic fresh water. Analysis was performed for the test concentration plus a control on daily basis. 

Observations were made on the number of dead fish and for the visible effects on appearance and behaviour of fish after 2, 24, 48, 72 and 96 h of exposure. 

 

Under the test conditions, the 96 h LC0 value of the test substance (including inorganic components) was determined to be 103.4 mg/L.

Description of key information

The 96 h LC0 value of the test substance (including inorganic components) was determined to be ≥103.4 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

A study was performed to assess the acute toxicity of test substance to Zebra fish (Brachydanio rerio)under static conditions. The study was conducted in accordance with EU Method C.1.

Groups of ten fish of the recommended size were exposed to a limit test concentration of nominally 100 mg/L of test substance dissolved in synthetic fresh water. Analysis was performed for the test concentration plus a control on daily basis. 

Observations were made on the number of dead fish and for the visible effects on appearance and behaviour of fish after 2, 24, 48, 72 and 96 h of exposure. 

 

The 96 h LC0 value of the test substance (including inorganic components) was determined to be 103.4 mg/L (Dr. Caspers, 1999).