N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27.08.1996 - 29.08.1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Nov 1989

Deviations:

yes

Remarks:

See remarks under 'Principles of method if other than guideline'

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

See remarks under 'Principles of method if other than guideline'

Principles of method if other than guideline:

Deviation:
pH values were measured in replicate 1 at all concerntrations at 0h and at 48h.
Reported pH values are in the range 7 - 9.1.
According to EU Method C.2 quality criteria the pH should not vary by more than one unit.

According to OECD TG 201 (Daphnia acute mobilisation test) the pH of the test medium should be in the range of 6 to 9.
In the reported results, two samples are reported to be outside this range. (100mg/L at 0h = 9.5 and 50mg/L at 0h = 9.1). In both cases the pH had normalised after 48h to 8.6 and 8.2 respectively.
The affected concentrations, 100mg/L and 50 mg/L were also tested as neutralisd samples (ph range 7.1-7.8).
The testing of the neutralised samples showed a less inhibitory effect on the swimming ability of Daphnia magna.

At 48hrs tested pH values were in the range 7-8.6 for all samples.
The pH of controls (test medium) was 8 at 0h and 48h.
All other recorded pH values are within the range 7-8.6.

The results of the pH determinations are presented in an attachment below.

Although the measured pH ranges vary by more than one unit, the ranges fall within the OECD TG 201 recommendation of a pH rane of 6-9, with the exception of 2 outliers.
The two affected concentrations (100mg/L at 0h = 9.5 and 50mg/L at 0h = 9.1) were also tested as neutralised samples (pH range 7.1-7.8). There is an evident concentration/effect relationship (attached).
Therefore, although the reported pH ranges represent a deviation, the outcomes of the test can be seen as representative. Other validity criteria are satisfied.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Substance name: N,N",N"",N""- Pentamethyldipropylentriamin
CAS no.3855-32-1
Purity: 98,5 % (Analytical Report ZAX No. 96L00390)
Stability: stable, storage at room tempe~rature under nitrogen atmosphere

Analytical monitoring:

yes

Details on sampling:

At the start of the test (after 0 hours) samples from vessels which were not stocked with daphnids were analyzed and at the end of the test (after 48 h) samples from stocked and unstocked vessels were analyzed to determine the concentration of the test substance.

The following nominal concentrations of the test substanc~ : were analyzed :
100 mg/L
25 mglL
3,13 mg/ L
0 mg/L (control )

Vehicle:

not specified

Details on test solutions:

The synthetic medium M4 was used for the culture and test . The medium is prepared on the basis of an ultrapure, deionized water (conductivity < 0 .05 NS/cm).

Test organisms (species):

Daphnia magna

Details on test organisms:

The clone of Daphnia magna STRAUS was supplied by Institut National de Recerche Chimique Appliquee, France, in 1978. The daphnids are cultured under standard conditions in the laboratory.
Animals were aged 2 - 24 hours at the start of the test.
The age of the stock animals was 2-4 weeks.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

2.48 mmol/L in test medium.

Test temperature:

at T= 0 h: 22.1 degrees C.
at T = 24 h: 21.1 degrees C.
at T= 48 h: 20.8 degrees C.

pH:

pH values were measured in replicate 1 at all concerntrations at 0h and at 48h.
Reported pH values are in the range 7 - 9.1.

According to EU Method C.2 quality criteria the pH should not vary by more than one unit.
According to OECD TG 201 (Daphnia acute mobilisation test) the pH of the test medium should be in the range of 6 to 9.

In the reported results, only two samples are reported to be outside this range. (100mg/L at 0h = 9.5 and 50mg/L at 0h = 9.1). In both cases the pH had normalised after 48h to 8.6 and 8.2 respectively.
The affected concentrations, 100mg/L and 50 mg/L were also tested as neutralisd samples (ph range 7.1-7.8).
The testing of the neutralised samples showed a less inhibitory effect on the swimming ability of Daphnia magna.

At 48hr tested pH values were in the range 7-8.6 for all samples.
The pH of controls (test medium) was 8 at 0h and 48h.
All other recorded pH values are within the range 7-8.6.

The results of the pH determinations are presented in the attachment below.

Although the measured pH ranges vary by more than one unit, the ranges fall within the OECD TG 201 recommendation of a pH rane of 6-9, with the exception of 2 outliers.
The two affected concentrations (100mg/L at 0h = 9.5 and 50mg/L at 0h = 9.1) were also tested as neutralised samples (pH range 7.1-7.8). There is an evident concentration/effect relationship (attached).
Therefore, although the reported pH ranges represent a deviation, the outcomes of the test can be seen as representative. Other validity criteria are satisfied.

Dissolved oxygen:

7.7 mg/L to 8.4 mg/L during duration of test.

Salinity:

NA

Conductivity:

0 - 650 NS/cm

Nominal and measured concentrations:

At T= 48h, analytical concentration ranged from 97.8% of nominal to 115.0% of nominal concentration. The analytical recovery rate was above 80% in all analysed test solutions after 48 h.

Details on test conditions:

TEST SYSTEM
- Test vessel: test tubes (glass) with flat bottom, nominal volume 2
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ultrapure deionised water (< 0.05 uS/cm).
- Alkalinity:0.80 - 1.00 mmol/L
- Ca/mg ratio:about 4:1
- Conductivity: 550-650 uS/cm
- Intervals of water quality measurement:0 h; 48 h.

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

35.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 31.0 mg/L - 40.4 mg/L

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Above a concentration of about 50 mg/L (nominal), the pH-values of the test samples rise over pH 8.5 at the beginning of the test. In these samples a strong inhibition of the swimming ability of Daphnia magna occured. The testing of the neutralised samples showed a less inhibitory effect on the swimming ability of Daphnia magna.

Results with reference substance (positive control):

NA

Reported statistics and error estimates:

For the statistical evaluation of the EC50 (48h) the moving average method was used .

Validity criteria fulfilled:

yes

Remarks:

In the control, immobilisation was less than or equal to 10%. Dissolved oxygen concentration at the end of the test was >3 mg/l in control and test vessels. pH values were outside guideline ranges, however the test is deemed valid, as discussed above.

Conclusions:

The acute toxicity of N,N,N',N'',N''-Pentylmethyldipropylentriamin to the water flea Daphnia magna was determined in accordance with guidelines (EU C2 methods for acute toxicity to Daphnia). An EC50 of 35.4 mg/L was determined.

Description of key information

 An acute daphnid toxicity study on the substance was conducted in accordance with EU C2 method, referencing OECD TG 202 (Daphnia sp Acute Immobilsisation Test)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

35.4 mg/L

Additional information

The acute toxicity of the substance to the water flea Daphnia magna was determined in accordance with guidelines (EU C2 methods for acute toxicity to Daphnia). The following values were determined from the test: 48-h EC₀ = 25 mg/L; 48-h EC₅₀ of 35.4 mg/L; and 48-h EC₁₀₀ = 100 mg/L. Above a concentration of about 50 mg/L (nominal), the pH-values of the test samples rose to a level pH 8.5 at the beginning of the test. In these samples a strong inhibition of the swimming ability of Daphnia magna occurred. The testing of the neutralised samples showed a less inhibitory effect on the swimming ability of Daphnia magna.