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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2016-10-28 to 2016-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guidance Document, No.23, September 2000, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures
Deviations:
no
Qualifier:
according to
Guideline:
other: Daphnia sp., Acute Immobilization Test stipulated in the "Testing Methods for New Chemical Substances"
Version / remarks:
(March 31, 2011, No. 0331-7, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, No. 5, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry; No. 110331009, Environmental Policy Bureau, Ministry of the Environment, Japan; latest revision, December 21, 2015, No. 1221-1, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; December 9, 2015, No. 1, Manufacturng i Industries Bureau, Ministry of Economy, Trade and Industry; No. 1512211, Environmental Policy Bureau, Ministry of the Environment, Japan)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Chemical name: Reaction product of 3-dimethylaminopropylamine and propylene oxide with 1,1'-[(3-dimethylaminopropyl)imino]-bis-2-propanol and 1-[(3-dimethylaminopropyl)(2-hydroxy-1-methylethyl)amino]-2-propanol as main component
- Name of test material (as cited in study report): DMAPA-2PO
- CAS number: CAS 63469-23-8 (1,1'-[(3-(dimethylaminopropyl)imino)]-bis-2-propanol)
- Molecular formula: C11H26N2O2 (main component)
- Molecular weight: 218.3 (main component)
- Substance type: yellow liquid
- Physical state: liquid
- Analytical purity: 100 %
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 5Y1024
- Expiration date of the lot/batch: NA
- Stability under test conditions: stable
- Storage condition of test material: cooll and dark place
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test sample of 330 mg was weighed and then mixed to dilution water of 3L and stirred to produce a stock solution of 110 mg/L. Required volumes of the stock solution and dilution water were mixed and stirred in a preparation container to prepare the test solution which was divided into each test vessel. In addition, the pH of the 110 mg/L stock solution was adjusted to it of the dilution water with 1 mol/L hydrochloric acid solution to prepare pH adjusted stock solution. Required volumes of the pH adjusted stock solution and dilution water were mixed and stirred in a preparation container to prepare the pH adjusted test solution which was divided into each test vessel.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water-flea
- Source: The University of Sheffield, UK, July 9, 1990
- Age at study initiation (mean and range, SD): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Feeding during cultivation: Chlorella vulgaris of 0.1- 0.2 mgC (Organic carbon content)/day per Daphnia was fed to the parents once a day.
- Feeding during test: no

ACCLIMATION
- Acclimation period: Y mmg daphnids produced by parents that were cultured in this laboratory were used. The parents to obtain young daphnids were bred in the same quality of water (dechlorinated tap water), water temperature (20±1°C) and photoperiod (16-hour light/8-hour dark) as used in the test. The parent animals used for the test were same lot and their age and survival rate were 14-day old and 100%, respectively.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
28 mg/L as CaCO3
Test temperature:
pH unadjusted:
20.0 - 20.2 °C
pH adjusted:
20.2 - 20.3 °C
pH:
pH unadjusted:
7.9 - 9.6 mg/L
pH adjusted:
8.8 - 8.9 mg/L
Dissolved oxygen:
> 3 mg/L
Salinity:
not relevant
Conductivity:
not relevant
Nominal and measured concentrations:
Range finder:
Nominal concentrations: 10 and 100 mg/L

Measured concentrations (static) at t=0h: 6.35, 86.5, 96.9 mg/L (pH adjusted)
Measured concentrations (static) at t=48h: 6.10, 83.8 mg/L

Final test:
Nominal concentrations (pH unadjusted): 21.7, 32.6, 48.9, 73.3, 110 mg/L
Nominal concentrations (pH adjusted): 21.7, 32.6, 48.9, 73.3, 110 mg/L

Measured concentrations (pH unadjusted) at t=0h: n.d., 13.3, 25.9, 39.2, 67.7, 95.8 mg/L
Measured concentrations (pH unadjusted) at t=48h: n.d., 12.2, 27.5, 36.4, 59.96, 99.6 mg/L

Measured concentrations (pH adjusted) at t=0h: 14.5, 27.3, 44.2, 71.4, 109 mg/L
Measured concentrations (pH adjusted) at t=48h: 13.9, 26.1, 40.8, 69.6, 122 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Type (delete if not applicable): Transparent plastic lid
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 100 mL
- 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
- Test medium: adjusted ISO medium

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Range finding study
- Test concentrations: 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Remarks:
pH unadjusted
Effect conc.:
> 97.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Remarks:
pH adjusted
Effect conc.:
> 115 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: no
- EC50/LC50: 48-h EC50 = 0.14 mg/L. This value was within the stipulated range (mean± 2S.D.) [mean ± S.D.: 0.23±0.06 mg/L (n=97)] to background data in this laboratory.
Reported statistics and error estimates:
Since more than 50% immobility could not be obtained in the exposure level, the ECso value was estimated as ">maximum test concentration"
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of DMAPA-2PO to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. Based on geometric mean concentrations, the 48-h EC50 were > 97.7 mg/L (pH unadjusted) and > 115 mg/L (pH adjusted). It was concluded that the test item has no remarkable acute effect on the test item. The results of the test can be considered reliable without restriction.

Description of key information

Two studies were performed with the test subtance.

In the first study from Adachi (2016), which was considered as key study, the acute toxicity of the test substance to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. Based on geometric mean concentrations, the 48-h EC50 were determined to be > 115 mg/L. It was concluded that the test item has no remarkable acute effect on daphnia.

The second study study from Migchielsen (2002) was a limit test performed under GLP conditions and according to OECD TG 202. The study however was given a Klimisch score of 2 as no analytical measurements were performed. An EC50 > 100 mg/L based on nominal concentrations was found for juvenile Daphnia magna after an exposure period of 48 hours in a static test.

Measurements and analytical determinations are an OECD requirement. While analytical measurements were included in the study of Adachi (2016), this was not the case for the study of Migchielsen (2002), in the latter study the results were expressed as nominal concentrations. As the newer study of Adachi (2016) follows the OECD 201 guideline for algae testing, the 48-h EC50 value for immobility of > 115 mg/L was considered as key study for the PNEC derivation.


Key value for chemical safety assessment

Additional information