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

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

19 Feb. 2010 to 25 Mar. 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Principles of method if other than guideline:

Deviations :
The immobilised daphnia were counted for the first time after 25 hours and 45 minutes instead after 24 hours. This deviation was meaningless for the result of the test. The deviation was signed and assessed by the study director on 30. Mar. 2010.
On request of the sponsor, no analytical determination of the content of the test item in the test solutions during the test was made.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

259-201-9

EC Name:

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

Cas Number:

54528-00-6

Molecular formula:

C7H14N2

IUPAC Name:

octahydrocyclopenta[c]pyrrol-2-amine

Test material form:

liquid

Remarks:

Colourless

Test solutions

Vehicle:

no

Details on test solutions:

Deionised water with an enrichment of certain minerals (as demanded in the guidelines) is used in the test. The dilution water specification is :
CaCl2*2H20 = 293.80 mg/L
MgS04*7H20 = 123.30 mg/L
NaHC03 = 64.80 mg/L
KCl = 5.80 mg/L
Resultin hardness = 2.50 mmol/L
Resultin hardness = 250 mg CaCO3/L

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna
Variety: STRAUS
Strain: Berlin
Sex: female
Age: between 0 and 24 hours
Origin: Umweltbundesamt Berlin
Arrival of Strain: 27. sep. 2007

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Test conditions

Hardness:

Resultin hardness = 2.50 mmol/L
Resultin hardness = 250 mg CaCO3/L

Test temperature:

20.8°C at T0 hour
19.9°C at T24hours
19.9 at T48 hours

pH:

pH is 7.7(mini) to 8.5 (maxi) at T0 hour
pH is 7.7 (mini) to 8.0(maxi) at T48 hours

Dissolved oxygen:

O2 concentration is 8.8mg/L (mini) to 9.3mg/L (maxi) at T0 hour
O2 concentration is 8.8mg/L (mini) to 8.9mg/L (maxi) at T48 hours

Salinity:

Not specified

Conductivity:

Not specified

Nominal and measured concentrations:

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

Details on test conditions:

No feeding and no lighting.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr207 (CAS No. 7778-50-9) was used as positive control.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 10 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

NOEC 24h = 0.5mg/L
24h EC50i = 1.2mg/L
24h EC100i = 2.5mg/L

Any other information on results incl. tables

Immobilities

In the control, none of the daphnia died or showed any signs of abnormal behaviour throughout the test.

Table of immobilities:

Nominal Concentration in mg/L	Immobility 24 hours					Immobility 48 hours
	abs.				in %	abs.				in %
0	0	0	0	0	0	0	0	0	0	0
1	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0
100	3	5	3	4	75	4	5	4	4	85

 

pH and O₂, Temperature

The pH values in the test media and the control ranged from 7.7 to 8.5. The concentrationof dissolved oxygen stayed above 8.8 mg/L throughout the test. Temperature range was 19.9 — 20.8^oc. The details are given in the following tables:

 

Table of pH and O₂values:

Nominal Concentration in mg/L	pH		02-Concentration in m IL
	0 h	48 h	0 h	48 h
0	7.7	7.7	9.3	8.8
1	7.7	7.7	8.8	8.9
10	7.8	7.8	8.9	8.8
100	8.5	8.0	9.2	8.9

 

 

Table of temperatures :

Temperature in C
0 h	24 h	48 h
20.8	19.9	19.9

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria were met. For the estimation of the EC50 of the positive control, the fits showed sufficient statistical correspondence of the data with the dose-response-equation. The 24h-EC50i of potassium dichromate was determined as 1.3 mg/L, lying within the demanded range of 0.6 — 1.7 mg/L.
The result of the test can be considered valid.

Executive summary:

The main study was performed using three concentrations containing 1, 10 and 100 mg/L. Twenty daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.

The highest concentration showed toxicity: 75 % immobilisation after 24 h and 85% immobilisation after 48 h. No animals were immobilised in the control.

The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 1.3 mg/L, lying within the demanded range of 0.6 — 1.7 mg/L.

The following results were determined for the test item 3-AMINO 3-AZABICYCLO(3,3,0)OCTANE ("AMINAZA PURIFIEE") (species: Daphnia magna).

24h-NOEC = 10 mg/L

48h-NOEC = 10 mg/L

24h-EC50i: 10 -100 mg/L

48h-EC50i: 10 -100 mg/L