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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
Study period:
2015-12-06 to 2016-01-18
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): JNJ-150098-AAC (T001310)
- Molecular formula (if other than submission substance): C6H11NO2.HCl
- Molecular weight (if other than submission substance): 165.62
- Physical state: white powder
- Analytical purity: 97.4 % (base titration), 98.7 % (acid titration)
- Impurities (identity and concentrations): water 0.1%
- Purity test date: 2014-11-25
- Lot/batch No: I14KB4913
- Expiration date of the lot/batch: 2020-11-23 (retest date)
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- Other: solubility in water: 320 g/L
Specific details on test material used for the study:
Batch I14KB4913
Purity/Composition 97.4%
Test item storage conditions At room temperature
Stable under storage conditions until 23 November 2020 (retest date)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 1.0 mL of volume was taken from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling.
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 1.0 mL were taken for possible analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with the highest concentration (100 mg/L). Only vigorous mixing (vortexing) was needed to fully dissolve the test item in test medium at the highest concentration prepared.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final solutions were clear and colourless

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids are placed into 5 L of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no

ACCLIMATION
- Acclimation period: max. 4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: freshwater algae
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
180 mg/L expressed as CaCO3
Test temperature:
between 19 and 20 °C
pH:
At t= 0h: 6.7 - 7.5
At t= 48h: 7.7 - 7.8
Dissolved oxygen:
at t= 0h: 8.9 - 9.1
at t= 48h: 8.6 - 8.8
Salinity:
not relevant
Nominal and measured concentrations:
Final test
Nominal concentrations (mg/L): 0, 10, 18, 32, 56, 100
Measured concentrations (mg/L) at t=0h: n.a., 11.3, 17.7, 31.7, 52.1, 93.7
Measured concentrations (mg/L) at t=48h: n.a., 11.0, 19.1, 31.9, 50.0, 94.3
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x1.8
- Range finding study
- Test concentrations: 0.10, 1.0 and 10 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
92 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 78-110 mg/L
Details on results:
- Behavioural abnormalities: no data
- Mortality of control: no
- Other adverse effects control: no
Results with reference substance (positive control):
- Results with reference substance valid? yes (should lie between 0.3 and 1.0 mg/L)
- EC50/LC50: 48h-EC50 = 0.38 mg/L
Reported statistics and error estimates:
Calculations of EC50.
The 48h-EC50-value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (initially measured) using the maximum likelihood estimation method.
The 24h-EC50 could not be determined because the observed effects were below 50%
ToxRat Professional v 3.0.0. (ToxRat Solutions gmbh, Germany) was used to perform the analyses.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T001310 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
The 48h-EC50 was determined to be 92 mg/L (95% CL 78-110 mg/L). The results of the test can be considered reliable without restriction.