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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

study plan 2003-01-06, final report 2003-03-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[TN]Ro 1525[/TN][SPEC][/SPEC][AM]99 %[/AM]

IUPAC Name:

[TN]Ro 1525[/TN][SPEC][/SPEC][AM]99 %[/AM]

Details on test material:

Batch No.: Ro 3962-88
Test Item: SAT 020874
appearance: pale green powder
purity: 98.4 %
melting point: > 300°C
vapour pressure: 10E-8 hPa at 20°C
solubility in water > 1000 mg/l

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

23±1 °C

pH:

nom. conc. pH
(mg/L) 0h 24h 48h 72h 96h
0 7.7 8.3 8.2 8.1 7.8
100 6.8 6.9 7.0 7.9 6.9

Dissolved oxygen:

nom. conc. oxygen (mg/L
(mg/L) 0h 24h 48h 72h 96h
0 9.7 9.5 9.3 9.4 9.0
100 9.8 9.2 9.1 9.4 9.0

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

The validity criteria were met.

The half-life of SAT 020874 in the test medium was determined with 1.3 hours. As the test was performed as a flow-through test with a minimum test medium renewal of 4 times per hour, it can be assumed that the concentration of the test item has stayed above 80 % throughout the test. Thus the result of the test can be considered valid.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

In the initial experiment, four concentrations of the test item in a geometric series (spaced by factor 10, the highest being 100 mg/L) were used. For each concentration, three fish were exposed to the test item for 96 hours. At the tested concentrations, no fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the treatments were normal. The main study was performed as a limittest using a nominal concentration of 100 mg/L. No fish showed any signs of morbidity at the end of the test.

In phase 2 of the study, the half-life of the test item using a concentration of 100 mg/l in dilution water was tested. A value of 1,3 hours was determined. In order to keep a concentration level of 80 % of the test item, the flow-through System was Set to a

medium exchange of 4-fold per hour. The following result for the test item SAT 020874 could be determined:

96h-LC50 = > 100 mg/L