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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
June to August 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
One main deviation noted, no chemical analysis was performed. The report is brief and doesn’t include background details of culturing etc.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
yes
Remarks:
One main deviation noted, no chemical analysis was performed.
GLP compliance:
yes
Specific details on test material used for the study:
Betadet S-20
Batch number 2GR043.0001

The Certificate of Analysis (not included in the report) provides the following information:
Batch: 2GR043.0001 (19/10/1995)
Appearance: Liquid, transparent, slightly yellowish fluid
Dry matter: 45%
pH: 6.8
Colour: 36 APHA units
Sodium chloride: 7.1%

The principal constituent (included in the 45% 'dry matter') represented approximately 30% (w/w) of the tested batch.
Analytical monitoring:
no
Details on sampling:
Not applicable
Vehicle:
no
Details on test solutions:
The test material was dissolved in water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Fish were obtained from a commercial supplier: Meridiana Aquarium SA, Barcelona and were held in quarantine for 12 days prior to test initiation. The fish were fed daily, up to 24h before the start of the test.
Fish were held is glass aquaria with a capacity of 84 L, pH was in the range of 8.0 - 8.6 and temperature was maintained between 20 and 24°C.
Fish were 3.4 - 3.8 cm at the end of the preliminary study and 3.0 - 3.5 cm at the end of the definitive test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
None
Post exposure observation period:
Not applicable
Hardness:
195.8 - 231.4 mg/L as CaC03 during the definitive study
Test temperature:
21.0 - 25.9°C
pH:
8.15 - 8.46 during the definitive study
Dissolved oxygen:
Maintained between 65 and 90% of the Air Saturation Value
Salinity:
Not applicable (freshwater test)
Conductivity:
Not applicable
Nominal and measured concentrations:
Nominal exposure concentrations - 0 (control), 100, 141.4, 168.2, 200 and 400 mg/L.
Details on test conditions:
Test vessels used in the definitive test were glass aquaria containing 50 L of test medium.
20 fish were exposed in the control and 100, 168.2 and 200 mg/L treatments and 10 were exposed at the 141. and 400 mg/L treatments.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
55.2 mg/L
Nominal / measured:
nominal
Conc. based on:
other: principal constituent
Basis for effect:
mortality (fish)
Remarks on result:
other: Calculated from reported endpoint as (184 x 0.3), based on 30% (w/w) principal constituent content of tested batch.
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
184 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Endpoint determined by graphical interpolation from the mortality response curve.
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
168.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
< 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Remarks on result:
other: Symptoms included inactivity, sounding in the aquaria, cessation of swimming and rapid respiration.
Details on results:
The 96 h LC50 for Betadet S-20, based on nominal exposure concentrations was determined graphically to be 184 mg/L. This is equivalent to 55.2 mg principal constituent/L after correction for the 30% (w/w) p.c. content of the tested batch of Betadet S-20.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No statistical analyses were performed. The LC50 was determined graphically.
Sublethal observations / clinical signs:

Mortality observations

Nominal concentration (mg/L)

No. of fish exposed

Cumulative mortality

% mortality at 96 hours

3 hours

24 hours

48 hours

72 hours

96 hours

Control

20

0

0

0

0

0

0

100

20

0

0

0

0

0

0

141.4

10

0

0

0

0

0

0

168.2

20

0

0

0

0

0

0

200

20

0

14

17

19

19

95

400

10

10

10

10

10

10

100

 

Validity criteria fulfilled:
yes
Conclusions:
The 96 h LC50 for Betadet S-20, based on nominal exposure concentrations was determined graphically to be 184 mg/L. This is equivalent to 55.2 mg principal constituent/L after correction for the 30% (w/w) p.c. content of the tested batch of Betadet S-20.
Executive summary:

The acute toxicity of Betadet S-20 to Zebra fish (Brachydanio rerio) was determined in a static study carried out according to OECD test guideline 201 (1992). Fish were exposed to nominal test concentrations of 0 (control), 100, 141.4, 168.2, 200 and 400 mg/L for 96 hours. No analytical verification was performed therefore the results of the study are based in the nominal exposure concentrations. 

The 96 h LC50 for Betadet S-20 was determined graphically to be 184 mg/L with a corresponding NOEC of 168.2 mg/L, based on mortality. The LC50 and NOEC equate to 55.2 and 50.5 mg principal constituent/L, respectively, after correction for the p.c. content of the tested batch of Betadet S-20.

Description of key information

The 96 h LC50 for Danio rerio exposed to Betadet S-20 was determined to be 184 mg/L with a corresponding NOEC of 168.2 mg/L, based on mortality. The LC50 equates to 55.2 mg principal constituent/L after correction for the p.c. content of the tested batch of Betadet S-20.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
55.2 mg/L

Additional information