2,2'-Methylenebis(4-aminophenol) dihydrochloride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study plan 09 November 2000, Final report 27 February 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appendix to the EU-Guideline 92/69/EWG from 31 July 1992

Principles of method if other than guideline:

The Daphnia are exposed to the test substance added to water at a range of concentrations for 48 hours. Under otherwise identical test conditions, and an adequate range of test substance concentrations, different concentrations of a test substance exert different average degrees of effect on the swimming ability of Daphnia. Different concentrations result in different percentages of Daphnia being no longer capable of swimming at the end of the test. The concentrations causing zero or 100% immobilisation are derived directly from the test observations whereas the 48-hour EC50 is determined by calculation if possible.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Active Matter = 98,4 %
Substance-No.: SAT 000926
Batch-No.: GN 1-56 39/62-88

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

A stock solution of 1 g test material per litre M4-medium was prepared. from this solution a second clear stock solution was prepared by 1:100 dilution. Appropriate volumes were taken from the second solution, tranferred into the test vessels and filled up to about 40 ml with M4-medium. The end volume of 50 ml was adjusted after the transfer of the test organisms into the test vessels.
At the test start the test solutions were clear. With increasing test substance concentration (3 mg/L and more) and with increasing test duration increasing precipitation was observed.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organims were obtained as ephippia in december 2000 from Creasel, 98000 Deinze, Belgium.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

Sythetic mineral water M4-medium according to Elendt

Test temperature:

20 °C

pH:

test concentration (mg/L)
(nominal) pH
0 8.0
0.1 8.0
0.3 8.0
1 7.9
3 7.9
10 7.9
30 7.8
100 7.8

Dissolved oxygen:

test concentration (mg/L)
(nominal) oxygen saturation (%)
0 98
0.1 98
0.3 98
1 98
3 98
10 97
30 97
100 97

Salinity:

Sythetic mineral water M4-medium according to Elendt

Nominal and measured concentrations:

nominal concentration measured concentration (mg/L)
(mg/L) 0h 24h 48h
1 <1 <1 <1
3 <1 <1 <1
10 <1 <1 <1
30 6.3 <1 <1
100 34.7 32.1 9.9

Details on test conditions:

Test vessels 100mL glass beakers, coverd with glass plates
Test volume 50mL
Illumination ~ 900 LUX, 16/8 hours light/dark rhythm
No. of test organisms 20 organisms per concentration in 2 groups of 10
Test duration 48 hours

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

0.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.75 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

2.95 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Results with reference substance (positive control):

The 24 hours EC50 of the reference substance potassium dichromate was 1.2 mg/L and thus within the target range of 0.9-1.9 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of Ro 1525 against Daphnia Magna was tested according to EU-Guideline 92/69/EWG of 1992. After 48 hours the effect concentration (EC50) reached 0.75 mg/l related to active substance based on nominal concentration.

Executive summary:

The acute toxicity of Ro 1525 against Daphnia Magna was tested according to EU-Guideline 92/69/EWG of 1992. After 48 hours the effect concentration (EC50) reached 0.75 mg/l related to active substance based on nominal concentration.