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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
feb 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
EC Number:
276-851-9
EC Name:
(±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
Cas Number:
72797-41-2
Molecular formula:
C21H25ClN2O4S
IUPAC Name:
(±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
Batch 562371/016 - 100% purity -

Sampling and analysis

Analytical monitoring:
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 cm
Supplier : Dehner Garten-Center, D.67433 Neustadt
Date of arrival : Jan 21st 2010
Before 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:
static
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:
24.2- 25.2°C
pH:
7.5 - 8.1
Dissolved oxygen:
7.3 mg/L or 82.5%
Nominal and measured concentrations:
nominal : 1/ 10 / 100 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
The mortality in the control may not exceed 1 fish at the end of the test. No mortalities occurred in the
control.
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 1574 ACIDE could be determined : 96h NOEC = 100 mg/L and 96h LC50 >100 mg/L
Executive summary:

The toxicity against Danio rerio was tested using a static test design.

The main study was performed using three concentrations ranging from 1 to 100 mg/L.

Treatments and control showed no mortality

The following results for the test item 1574 Acide could be determined : 96h NOEC = 100 mg/L and

96h LC50 >100 mg/L