m-phenylenebis(methylamine)

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

The study was conducted between 1995-12-18 and 1995-12-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

no analytical monitoring of test material concentration

GLP compliance:

no

Analytical monitoring:

no

Details on sampling:

No data

Vehicle:

no

Details on test solutions:

Following the intital range-finding study the following test concentrations were assigned to the definitive study: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/L

Test organisms (species):

Daphnia magna

Details on test organisms:

No data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

No data

Hardness:

The reconstituted water had an approximate theoretical total hardness of 270 mg/L as CaCO3

Test temperature:

21 degrees Centigrade

pH:

The pH of reconstituted water was 7.8 ± 0.2. No pH data is available for the test solution.

Dissolved oxygen:

No auxiliary aeration. The reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value

Salinity:

No data

Nominal and measured concentrations:

1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/L

Details on test conditions:

The test solution was prepared by direct dispersion of the test material in reconstituted water

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

24 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits 18-32 mg/L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

16 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits 14-19 mg/L

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Details on results:

Analysis of immobilisation data given in Table 1 (see below) gave the following results:

Time (h) EC50 (mg/L) 95 % confidence limits
24 24 18-32*
48 16 14-19

* Concentrations resulting in 0 and 100 % immobilization respectively.

No Observed Effect Concentration at 24h = 18 mg/L
No Observed Effect Concentration at 48h = 10m/L

The No Observed Effect Concentration is based upon zero immobilisation at this test concentration.

Results with reference substance (positive control):

No data

Reported statistics and error estimates:

No data

Results from a range-finding study conducted between 14 December 1995 and 16 December 1995 are shown below:

Concentration mg/L	Cumulative Mortality (initial population = 10)
	24 Hours	48 Hours
Control	0	0
0.10	0	0
1.0	0	0
10	0	0
100	10	10

Cummulative immobilisation data from the exposure of Daphnia magna to MXDA for 48 hours are given in Table 1:

Table 1 - Cumulative immobilization data for Daphnia magna exposed for 48 hours to MXDA

Nominal Concentration (mg/l)	Cumulative immobilizedDaphnia (intial population : 10 per replicate)
	24 hours				48 hours
	R1	R2	Total	%	R1	R2	Total	%
Control	0	0	0	0	0	0	0	0
1.0	0	0	0	0	0	0	0	0
1.8	0	0	0	0	0	0	0	0
3.2	0	0	0	0	0	0	0	0
5.6	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0
18	0	0	0	0	6	7	13	65
32	10	10	20	100	10	10	20	100
56	10	10	20	100	10	10	20	100
100	10	10	20	100	10	10	20	100

R₁and R₂= Replicates 1 and 2

Conclusions:

The EC50 value at 24 hours is given as 24 mg/L and the EC50 value at 48 hours is reported as 16 mg/L. The No Observed Effect Concentration at 24 hours is stated as 18 mg/L and the No Observed Effect Concentration at 48 hours is 10 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

pH values for the 16.0, 28.0 and 50.0 mg/L concentration levels were 8.7 or greater which were considered to be slightly high. This was considered to be due to the slightly alkaline nature of the test material.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Sampling was conducted every 24 hours

Vehicle:

no

Details on test solutions:

Nominal concentrations: Control, 5.00, 8.90, 16.00, 28.0, 50.0 mg/L

Test organisms (species):

Daphnia magna

Details on test organisms:

No data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

No data

Hardness:

No data

Test temperature:

20 ± 1 degrees Centigrade

pH:

pH 7.6 - 9.3

Dissolved oxygen:

8.3 - 8.9 mg/L

Salinity:

No data

Nominal and measured concentrations:

Nominal concentrations: Control, 5.0, 8.9, 16.0, 28.0, 50.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: closed with the surface of the water covered with a teflon sheet
- Fill volume: 100mL
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of individuals per dose level: 20

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium - see table A-1 (attached)

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: 800 lux

EFFECT PARAMETERS MEASURED: Immobilisation

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

16 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

35.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limit: 28.0 - 50.0 mg/L

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

8.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

15.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limit: 12.3 - 18.7 mg/L

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

28 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Measured concentrations of the test material were within ± 20 % of the nominal concentrations for all test concentrations, therefore, the nominal concentrations were used for calculation of each effect concentration. Representative chromatograms are attached.

No environmental factors which might affect the reliability of the study results were seen.

The immobilisation rate of the control group after 48 hours exposure was zero %, and the rate of Daphnia floating on the surface of the water was zero %, which fulfilled the validation criteria of the study.

In this study, 5 % immobilization was seen in the 5.00 mg/L group at the end of exposure, however, the immobilization seen in the 5.00 mg/L group was considered to be within the range of spontaneous occurrence since no immobilization was seen in the 8.9 mg/L group.

The temperature of the test solutions were 20 ± 1 degrees Centigrade for all test groups, and the dissolved oxygen concentrations were 60 % or more of the saturated concentration of the dissolved oxygen concentration (dissolved oxygen concentration at 20.0 degrees Centigrade: 8.8 mg/L). Both of these values fulfilled the study standards. The pH values shown in the 16.0 mg/L, 28.0 mg/L and 50.0 mg/L groups were 8.7 or more, and were considered to be slightly high. The effect was attributed to the slightly alkaline nature of the test material. The pH values in the other concentration groups, as well as the control group, were within the appropriate environmental range (6.0 ~ 8.5) for raising Daphnia.

Results with reference substance (positive control):

No data

Reported statistics and error estimates:

Statistical method
EC50 (48 hours): moving average

The concentration of the test material in the test solution was measured at the start of exposure and at the end of exposure (48 hours after the start of exposure). The results are shown in Table 1 (below):

Table 1 - Measured Concentrations of the Test Substance in Test Water (Static Conditions)

Nominal Concentration (mg/L)	Measured concentration (mg/L)				Geometric Mean during 48 Hours (mg/L)
	0 Hour new	Percent of Nominal	48 Hours old	Percent of Nominal
Control	<0.02	--	<0.02	--	--
5.00	4.98	100	4.92	98	4.95
8.90	9.03	101	9.04	102	9.03
16.00	15.9	99	15.9	99	15.9
28.0	28.0	100	27.9	100	27.9
50.00	49.6	99	49.7	99	49.6
New:	Freshly prepared test solutions
Old:	Test solutions after 48 Hours exposure

Immobilisation rate and median immobilisation concentration (EiC50) at each time point are shown in Table 2 and Table 3 (below). The concentration-immobilisation rate curve is shown in Figure 1 (attached).

Table 2 - The Numbers of Immobile Daphnia (Percent Immobility)

 

Nominal concentration (mg/L)	Cumulative Numbers of Immobilized Daphnia (Percent Immobility]
	24 hours	48 hours
Control	0 (0)	0 (0)
5.00	0 (0)	1 (5)
8.90	0 (0)	0 (0)
16.0	0 (0)	10 (50)
28.0	2 (10)	20 (100)
50.0	20 (100)	20 (1000

 

Table 3 - Calculated EiC50 values

 

Exposure period (hr)	EiC50 (mg/L)	95-Percent Confidence Limits (mg/L)	Statistical Method
24	35.1	28.0 ~ 50.0	Binomial
48	15.2	12.3 ~ 18.7	Moving average

 

The maximum no-observed effect concentration (NOECi) and the minimum 100 % immobilisation concentration are shown in Table 4 (below):

Table 4 - No Observed Effect Concentration (NOECi) and Lowest Concentration resulting in 100% Immobility

 

Exposure period (Hours)	No Observed Effect Concentration (NOECi) (mg/L)	Lowest concentration resulting in 100 % Immobility (mg/L)
24	16.0	50.0
48	8.90	28.0

The temperature of the test solutions, the dissolved oxygen concentration, and pH are shown (below) in Table 5, Table 6 and Table 7 respectively.

Table 5 – Temperature (Static Conditions)

 

Nominal Concentration (mg/L)	Temperature °C
	0 Hour New	48 Hours Old
Control	20.1	20.1
5.00	20.1	20.1
8.90	20.1	20.1
16.00	20.1	20.3
28.0	20.1	20.2
50.0	20.1	20.2
New:	Freshly prepared test solutions
Old:	Test solutions after 48 Hours exposure

 

Table 6 – Dissolved Oxygen Concentrations (Static Conditions)

 

Nominal Concentration (mg/L)	Dissolved Oxygen Concentration (mg/L)
	0 Hour New	48 Hours Old
Control	8.6	8.3
5.00	8.8	8.5
8.90	8.8	8.5
16.00	8.8	8.7
28.0	8.6	8.6
50.0	8.8	8.9
New:	Freshly prepared test solutions
Old:	Test solutions after 48 Hours exposure

 

Table 7 – pH Values

 

Nominal Concentration (mg/L)	pH
	0 Hour New	48 Hours Old
Control	7.9	7.6
5.00	8.4	8.1
8.90	8.6	8.5
16.00	8.8	8.7
28.0	9.1	9.0
50.0	9.3	9.2
New:	Freshly prepared test solutions
Old:	Test solutions after 48 Hours exposure

Validity criteria fulfilled:

yes

Conclusions:

EC50 values were found to be 35.1 mg/L (confidence limits 28.0 ~ 50.0 mg/L) at 24 hours and 15.2 mg/L (confidence limits 12.3 ~ 18.7 mg/L) at 48 hours.

Description of key information

EC50 (48 h) 15.2 mg/L for Daphnia magna (OECD 202)

EC50 (48 h) 16 mg/L for Daphnia magna (OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

15.2 mg/L

Additional information

Two studies are available to describe acute toxicity to Daphnia magna. A Japanese government study (1995) is considered the key study because it was conducted to GLP standards and included analytical monitoring of test material. However, a supporting study (Wetton, 1995) provides corroborative evidence of test material toxicity.