(±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide

Short-term toxicity to fish

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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 concentrations

Effect concentrations 1

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)

Effect concentrations 2

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