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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-09-15 to 1998-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline test under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
92/69/EWG, C.1; OECD Nr. 203
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance): - Name of test material (as cited in study report): PD 123408
- Physical state: White Poweder
- Composition of test material, percentage of components: not given
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
As Determined under Point 4

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.1; 0.21; 0.42; 0.97; 2.0 mg/l

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Source: Eye Research Centre, Suffolk, UK
- Length at study initiation (length definition, mean, range and SD): 3.8 cm; SD 0.33 cm
- Weight at study initiation (mean and range, SD): 0.7 g (SD 0.27 g)

ACCLIMATION
- Acclimation period: 13 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial fry pellets

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
<= 174 mg CaCO3/L
Test temperature:
14 °C
pH:
7.5 - 8.0
Dissolved oxygen:
8.1-9.0 mg/l
Nominal and measured concentrations:
Measured: Concentrations: 0.1; 0.21; 0.42; 0.97; 2.0 mg/l
Details on test conditions:
TEST SYSTEM

- Type (delete if not applicable): open 20 l vessels
- Renewal rate of test solution (frequency/flow rate): static
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):1
- No. of vessels per vehicle control (replicates):1
- Biomass loading rate: 0.25 g/l


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50, NOEC 0, 24, 48, 72 and 96 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 2 mg/L
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
1.95 mg/L
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
1.26 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.26 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
2 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.1 mg/L
Details on results:
%Concentration loss over test: max. 9% of nominal
Results with reference substance (positive control):
None used

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance is toxic to fish under the conditions used.
Executive summary:

To assess the acute toxicity a study according to OECD 203 (EU Guideline 92/92/EEC C.1) was performed with BIBEA. Concentration testsed ranged from 0.1 to 2.0 mg/l and a control. The control worked as expected. The LC40 (96h) was 1.26 mg/l with a 95% confidence interval of 0.87 to 1.92 mg/l, the NOEC was 0.1 mg/l.

The substance is toxic to fish under the conditions used.