Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No analytical determination was performed
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
No analytical determination was performed
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch ; 839411/006Purity : 100.9%Storage : room temperature (20°C +/-5°C)

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Variety : Hamilton-BuchananAge : sexually immature young fish , lenght 2 +/- 1 cmSupplier : Dehner Garten-Center, D.67433 NeustadtDate of arrival : Sept 6th 2007Before being used for the test, the fish were kept for 14 days under test conditions. During this period, mortality didn't surpass 5%.

Study design

Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
24/ 48/ 72: 96 hours

Test conditions

Test temperature:
20.3 - 20.4°C
pH:
7.7 - 8.1
Dissolved oxygen:
8.4 mg/L or 93%
Nominal and measured concentrations:
nomical : 1/ 10 / 100 mg/L
Details on test conditions:
Loading 1 fish/LVessels : glass aquaria, max volume 10 LAeration : accomplished with glass tubes, frequency of bubbles 1/sphotoperiod : 12/12 jours using neon tubesTemperature 23 +/- 1°CReplicates : one vessel, each containing 7 L test solution and 7 fishControl : one vessel, each containing 7 L dilution watert and 7 fish
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 - < 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The mortality in the control may not exceed 10% at the end of the test. No mortalities occurred in the control.No mortality at 1 mg/L100% mortality at 10 mg/L (1 at 24h and 6 at 48h)100% mortality at 100 mg/L (7 at 24h )
Reported statistics and error estimates:
The validity criteria were met

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
According the guideline OECD 203, the following results for the test item Mephttamin HCL could be determined : 96h NOEC = 1 mg/L and 96h LC50 = 1 - 10 mg/L
Executive summary:

The experiment was performed using three concentrations ranging from 1 to 100 mg/L. For each concentration, seven fish were exposed to the test item for 96 hours. The pH and the oxygen value of the water were normal.

In the treatment 10 and 100 mg/L 100% mortality was obersered. No mortality occured in the treatment 1 mg/L and in the control.

The following results for the test item Mephttamin HCL could be determined : 96h NOEC = 1 mg/L and 96h LC50 = 1 - 10 mg/L