Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study acc. to OECD guideline 203 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: >99%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Evidence of undissolved material (e.g. precipitate, surface film, etc): At the test start, the test subsatnce was very finely and homogeneously suspended in the test medium. After about two hours, test substance particles were observed at the water surface and the bottom of the aquarium.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
2.5 mmol/l as CaCO3
Test temperature:
water temperature ranged between 21 and 22 °C.
pH:
pH ranged between 7.9 and 8.1.
Dissolved oxygen:
Oxygen saturation was alwasy higher than 60%.
Nominal and measured concentrations:
During the test period the mean measured concentration of dissolved and suspended test substance in the unfiltrated duplicate samples of the suspension was 90% each of the nominal value.
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Details on results:
- Effect concentrations exceeding solubility of substance in test medium: yes
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
not applicable

Any other information on results incl. tables

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for environmental hazards.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
As no moratlity was observed, the 96-hour LC0 (NOEC) was determined to be at least 100 mg/l.
Executive summary:

Due to the low water solubilty of test item, an unfiltrated supersaturated suspension with a nominal concentration of 100 mg/l was used as the test medium, containing a max. concentration of the test substance.

During the test period the mean measured concentration of dissolved and suspended test substance in the unfiltrated duplicate samples of the suspension was 90% each of the nominal value. Under the test conditions, the concentration was sufficiently constant. during the 96 -hours test period. The concentration of dissolved and very finely suspended test subsatnce was below the detection limit of approx. 1.0 mg/l.

As no moratlity was observed, the 96-hour LC0 (NOEC) was determined to be at least 100 mg/l nominal.