Registration Dossier

Administrative data

Endpoint:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-10-30 to 1997-11-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN EN ISO 10712 (1), 1995
Deviations:
no
Principles of method if other than guideline:
The test is performed with bacteria of the genus Pseudomonas which grow in the presence of an easily degradable substrate. Upon addition of a
toxic concentration of a test material the growth rate decreases. The growth rate is determined by turbidimetry (436 nm; 1 cm cuvette). The
extinction coefficients were transformed into Formazin­Nephelometric-Units (FNU). Five concentrations (5 dilutions of a stock solution of 1 g/1) of the test material were tested. The concentrations at which the bacterial growth rate is decreased by 10 % (EC 10) and 50 % (EC 50), respectively, as
compared to the average value of untreated controls, are determined, if possible.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,6-Hexanediol dimethacrylate
- Substance type: organic
- Physical state at room temperature: liquid

Sampling and analysis

Analytical monitoring:
no

Test organisms

Test organisms (species):
Pseudomonas putida

Study design

Test type:
static
Limit test:
no
Total exposure duration:
16 h

Test conditions

Test temperature:
23 ± 1°C
Nominal and measured concentrations:
50, 100, 200, 400, and 800 mg 1,6-HDDMA/L (1.45, 2.9, 5.8, 11.6 and 23.2 mg 1,6-HDDMA/L concentration based on DOC-content)
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer-flask
- Aeration: no
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 3
- Incubation period: 5h ± 0.5h
- Stock solution: 1 g/L
Reference substance (positive control):
yes
Remarks:
 3,5-dichlorophenol

Results and discussion

Effect concentrations
Duration:
16 h
Dose descriptor:
EC0
Effect conc.:
800 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: Up to the highest nominal test concentration of 800 mg/L, 1,6-HDDMA had no effects (neither inhibition nor stimulation) on the growth of Pseudomonas putida.
Results with reference substance (positive control):
- Results with reference substance valid?: Yes

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
The EC50 of 3,5-Dichlorphenol was in the accepted range of 10 (0.23 % growth inhibition) to 30 (97.55 % growth inhibition) mg/L.
Conclusions:
In a valid growth inhibition test according (Pseudomonas putida) to DIN EN ISO 10712 (1), 1995 after a contact time of 16 h, the EC0 was determined to be greather than 800 mg/L. Up to the highest nominal test concentration of 800 mg/L, 1,6-HDDMA had no effects (neither inhibition nor stimulation) on the growth of Pseudomonas putida.
Executive summary:

In a valid growth inhibition test according (Pseudomonas putida) to DIN EN ISO 10712 (1), 1995 after a contact time of 16 h, the EC0 was determined to be greather than 800 mg/L. Up to the highest nominal test concentration of 800 mg/L, 1,6-HDDMA had no effects (neither inhibition nor stimulation) on the growth of Pseudomonas putida.

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