Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 1995 - Mar 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): M-DOC
- Analytical purity: 98.2%
- Lot/batch No.: 34514021

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

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

Study design

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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 2.2 - 3.6 mg/L

Any other information on results incl. tables

Table 1: Mortality of Zebra fish (Brachydanio rerio) after 96 hours exposure to ZK 9340 (n=10)

 Concentration of ZK9340    3 hours    6 hours    24 hours    48 hours    72 hours    96 hours.  
 (mg/I)                    
 control   0 0 0 0 0 0
0,5 0 0 0 0 0 0
0,9 0 0 0 0 0 0
1,8 0 0 1 1 1 3
3,8 0 3 7 7 8 8

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50/96 hours of ZK 9340 in Zebra fish was 2.7 mg/L (95% confidence limits: 2.2-3.6 mg/L).
The results ot this study showed that ZK 9340 is toxic to fish.
Executive summary:

The purpose o·f this study was to determine the acute toxicity (LC50/96 hours) of the substance M-DOC (ZK 9340) to Zebra fish Brachydanio rerio. ZK 9340 is an intermediate in the synthesis of fluocortolone.

Ten Zebra fish (Brachydanio rerio) were used for each of the test solutions and ten tor the control group. The fish were exposed to 4 different concentrations of the test substance (1 :80, 1 :40, 1 :20 and 1:10 dilution of a saturated solution) and the dilution water for aperiod of 96 hours. The test solution was prepared by suspending 100 mg/L of test substance and making appropriate dilutions of the filtrate after 24 hours stirring. Mortalities and visible abnormalities were recorded at approximately 3, 6, 24, 48, 72 and 96 hours. Samples tor the analysis by HPLC with UV detection were taken at 0, 48 and 96 hours.

The mean measured concentrations were 3.8 mg/L (1 :10 of the saturated solution), 1.8 mg/L (1:20),0.9 mg/L (1 :40) and 0.5 mg/L (1:80).

80% mortality was observed in the highest test concentration of 3.8 mg/L. Furthermore, 30% mortality was the result of the exposure of the fish at 1.8 mg/L. No further mortality was observed in the remaining test concentrations and the control during the whole exposure time. All the fish in the 4 test dilutions were slightly less active in comparison to the control group.