Hexahydrocyclopenta[c]pyrrol-2(1H)-amine

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

19 Feb. 2010 to 02 Mar. 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The following instruments and devices were used for this study:
- Automatic pipettes with one-way tips, LAUS No.: 31
- Glass measuring cylinders and flasks, 100 and 1000 ml

Test solutions

Vehicle:

no

Details on test solutions:

On the day of the start of the test, a stock solution containing 1 g/L test item was prepared. This solution was used to prepare three treatments containing 1, 10 and 100 mg/L.

Medium used: chlorine-free tap water, full composition analysed.
Medium renewal: twice a week
Dilution water : Good quality drinking water is used. The composition is analysed yearly by the supplier.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Danio rerio HAMILTON-BUCHANAN
sexually immature young fish, length 2 ± 1 cm
The animals were obtained from a commercial supplier. 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

Total exposure duration:

96 h

Test conditions

Hardness:

1.18 mmol/L

Test temperature:

24.2°C at T0
24.9°C at T24
25.2°C at T48
25.0°C at T72
25.2°C at T96

pH:

Between 7.9 and 8.3 at T0 hours
Between 7.6 and 7.8 at T96 hours

Dissolved oxygen:

between 8.9 mg/L and 9.6 mg/L at T0
between 8.4 mg/L and 8.8 mg/L at T96

Salinity:

Not specified (freshwater used)

Conductivity:

142 S/cm at 20°C

Nominal and measured concentrations:

Nominal concentration : 0 ; 1 ; 10 & 100 mg/L

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 - < 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortalities

The mortalities were recorded daily and can be found in the following table.

Table of mortalities:

Nom. Conc. in mg/L	Total of fish used	dead fish
		24 h	48 h	72 h	96 h
		cum	cum.	cum.	cum.
0	7	0	0	0	0
1	7	0	0	0	0
10	7	0	0	6	7
100	7	7	7	7	7

No abnormal behaviour of the surviving fish was observed.

pH and O2 Values, Temperature

The pH values in the test media and the control ranged from 7.5 to 8.3. The concentration of dissolved oxygen stayed above 6.9 mg/L or 78.9 % throughout the test. Temperature range was 24.2 — 25.2°C. The details are given in the following tables:

Table of pH and O₂Values

Nom. Conc.	pH at t in h					O2 in mg/L at t in h
mg/L	0h	24 h	48 h	72 h	96 h	0h	24 h	48 h	72 h	96 h
0	7.9	7.5	7.5	7.6	7.6	8.9	8.7	8.5	8.8	8.8
1	7.9	7.5	7.5	7.6	7.6	9.6	8.3	8.3	8.1	8.4
10	8.0	7.5	7.5	7.7	7.7	9.6	8.5	8.6	8.1	8.7
100	8.3	7.8	7.6	7.6	7.8	9.6	8.4	6.9	7.8	8.4

 

Table of temperatures

0 h	24 h	48 h	72 h	96 h
24.2	24.9	25.2	25.0	25.2

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria were met.
The test item 3-AMINO 3-AZABICYCLO(3,3,0)OCTANE ("AMINAZA PURIFIEE") showed mortality in treatments 10 and 100 mg/L.
No observations were made which might cause doubts concerning the validity of the study outcome.
The result of the test is considered valid.

Executive summary:

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

The main study was performed using three concentrations containing 1, 10 and 100 mg/L. Two concentrations showed mortality (86 and 100 %).

The following results for the test item 3-AMINO 3-AZABICYCLO(3,3,0)OCTANE ("AMINAZA PURIFIEE") could be determined:

96h NOEC = 1.0 mg/L

96h LC50 = 1 - 10 mg/L