Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 2015 - Jan 2016
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Remarks:
via HPLC-MS-MS
Details on sampling:
Sampling schedule:
Control : on day 0, 9 and 19 in the freshly prepared media; on day 2, 12 and 21 in the old media
Test concentration : on day 0, 9 and 19 in the freshly prepared media; on day 2, 12 and 21 in the old media
Vehicle:
no
Details on test solutions:
Ensured by renewal of test media three times per week and verified by chemical analysis (HPLC-MS-MS) according to the sampling scheme described below.
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna STRAUS, parthenogenetic females
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
The hardness of the dilution water ranged from 14.0 °dH to 16.0 °dH
(= 250 – 286 mg/L CaCO3) during the test.
Test temperature:
20 +/- 2 °C
pH:
7.6 - 7.8
Dissolved oxygen:
> 3 mg/L throughout exposure period
Nominal and measured concentrations:
10 mg/L (nominal)
Details on test conditions:
A 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1) was applied. The culture water (so-called 'M4 medium') was partly renewed once a week.
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: equal an analytical value of 0.1 μg/L (limit of quantitation).
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: equal an analytical value of 0.1 μg/L (limit of quantitation).
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equal an analytical value of 0.1 μg/L (limit of quantitation).
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equal an analytical value of 0.1 μg/L (limit of quantitation).
Details on results:
The criterion of adverse effects used in this study was the item-induced inhibitory effect on the parthenogenetic reproduction rate and the mobility behaviour/mortality rate of parent Daphnia, all effects being assessed at least three times a week.
Validity criteria fulfilled:
yes
Conclusions:
No toxic effects of Rubator MBTS against Daphnia were observed at a limit test concentration of 10 mg/L (nominal) over 21 days, which equals to an analytical value of 0.1 μg/L (limit of quantitation).
Executive summary:

Long-term toxicity on invertebrates were investigated according to OECD 211 over 21 days under semi static conditions in a daphnia reproduction test. Analysis was performed via HPLC-MS-MS. As a result, Rubator MBTS showed no toxic effect in a limit test with a nominal concentration of 10 mg/L which equal an analytical value of 0.1 µg/L which was the limit of quantification (Currenta, 2016). Therefore a 21d-NOEC of >= 10 mg/L (reproduction and mortality) and 21d-LOEC of > 10 mg/L (reproduction and mortality) could be determined.

Description of key information

No toxic effects of Rubator MBTS against Daphnia were observed at a limit test concentration of 10 mg/L (nominal) over 21 days, which equals to an analytical value of 0.1 μg/L (limit of quantitation).

Key value for chemical safety assessment

Additional information