Registration Dossier

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Apr - 14 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock solution of 100 g/L was prepared. Aliquots were transferred into test flasks in amounts resulting in a disolution series separated by a spacing factor of 2. To each flask 10 mL culture medium and 10 mL inoculum with a FNU of 50 at 436 nm are added. Flasks are filled up to a final volume of 100 mL.
Test organisms (species):
Pseudomonas putida
Details on inoculum:
- Laboratory culture: source: Deutsche Sammlung für Mikroorganismen (DSMZ, German Collection of Microorganisms and Cell Cultures)
- Preparation of inoculum for exposure: pre-culture grown for 7 h at 21 °C before inoculation. pre-culture diluted with sterile culture medium, resulting in a FNU (Formazine Nephelometric Units) of 50
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
16 h
Remarks on exposure duration:
16 ± 1 h
Test temperature:
21 ± 1 °C
Nominal and measured concentrations:
nominal: 0, 125, 250, 500, 1000, and 2000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 300 mL Erlenmeyer flasks, 100 mL fill volume
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2x
Reference substance (positive control):
no
Duration:
16 h
Dose descriptor:
EC10
Effect conc.:
300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Duration:
16 h
Dose descriptor:
EC50
Effect conc.:
640 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition

Table 1: Measured extinction values

Concentration (mg/L)

Replicate 1

Replicate 2

Replicate 3

Median value

control

1.314

1.332

1.358

1.335

125

1.448

1.355

1.351

1.385

250

1.362

1.401

1.309

1.357

500

0.901

0.949

0.912

0.921

1000

0.135

0.142

0.135

0.137

2000

0.031

0.026

0.024

0.027

Table 2: Inhibition values

Concentration (mg/L)

% inhibition of cell growth

125

-4

250

-2

500

32

1000

92

2000

100

Description of key information

EC10 = 300 mg/L with Pseudomonas putida (DIN 38412, part 8)
EC50 = 640 mg/L

Key value for chemical safety assessment

EC50 for microorganisms:
640 mg/L
EC10 or NOEC for microorganisms:
300 mg/L

Additional information

There is one microorganism study available for 2-amino-2-ethyl-1,3-propanediol (AEPD), which was used as key study for the assessment. The study was conducted according to the guideline DIN 38412, part 8 (Schopka, 1991). A culture of the bacterium Pseudomonas putida was exposed to AEPD for 16 hours, at the nominal test concentrations 125, 250, 500, 1000, and 2000 mg/L. The obtained EC10 and EC50 values were 300 mg/L and 640 mg/L, respectively.