Registration Dossier

Ecotoxicological information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Remarks:
HPLC/MS/MS

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Straus type, Daphnie between 6 and 24 hours old

Study design

Test type:
not specified
Water media type:
other: demineralised
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No information

Test conditions

Hardness:
No information
Test temperature:
20°C +/- 2°C
pH:
7.8
Dissolved oxygen:
8.1 mg/L
Nominal and measured concentrations:
Nominal concentrations: 26, 36, 51, 71, 100 mg/L
Measured concentrations: 21.2, 31.5, 53.5, 57.5, 105.4 mg/L at T0h and 27.6, 39.4, 54.8, 76.5, 104.9 mg/L at T48h
Details on test conditions:
Darkness conditions
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The daphnids immobilisation was determined at 5% for the 100 mg/L concentration. Therefore the EC50-48H could not be statistically determined.
The test item concentration at 100 mg/L after 48h did not vary more than ± 20 % of the concentration measured at T0. The concentration at T0 was measured within ± 20 % of the nominal concentration. Therefore the test item is considered stable in the test conditions and ecotoxicity test results were based on the nominal concentration 100 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on this study, the test substance hydroxy-novol-diamine gave the following results:
- 48h EC50 > 100 mg/L
- 48h EC10 > 100 mg/L
- NOEC = 100 mg/L
- LOEC > 100 mg/L