Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-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:
other: GLP guideline study without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Tinuvin 123 liquid
- Physical state: liquid
- Analytical purity: 100 % (UVCB)
The test substance is considered UVCB (substances of Unknown or Variable composition, Complex reaction products or Biological materials).
The test item shows the expected IR bands.
- Lot/batch No.: RC31620001
- Expiration date of the lot/batch: June 01st, 2015

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen Germany.
- Age of parental stock (mean and range, SD): Daphnia brood stocks are kept in mass cultures consisting of approx. 20 – 30 individuals for a maximum of 4 weeks. All individuals in the mass culture originate from a single female. After approximately 14 days the adults have produced at least 3 broods and the young can be used in tests.
- Feeding during test: Yes
- Food type: During the test daphnids were fed daily a diet of live green algae Desmodesmus subspicatus, cultured in a synthetic medium.
- Amount: The
algae were separated from their culture medium by centrifugation, resuspended in daphnid's medium (M4) corresponding to concentrations of 2050 mg and 1650 mg TOC*/L (respectively) in the algal concentrates used. The daphnids were fed a defined volume (≤ 121 μL) of the concentrate.
- Frequency: daily

ACCLIMATION
- Acclimation period: The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality, temperature (20 ±1°C), and diet.
- Acclimation conditions (same as test or not): yes

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d

Test conditions

Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 100 mL nominal, filled with 50 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 0.02 animals / mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A synthetic fresh water (Elendt M4) is used as media for culture and test purposes
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16:8 light/dark
- Light intensity: about 613 - 649 lux at a wave length of 400 - 750 nm

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, reproduction and other sublethal effects. Additional
endpoints (i.e. growth, immobile young, time to first brood, or aborted eggs) were checked
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction

Applicant's summary and conclusion

Validity criteria fulfilled:
yes