Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15th-17th January, 2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

no

Remarks:

GLP not required at time of test initiation

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Maplewood, Lot# 20125
- Expiration date of the lot/batch: >1 year after manufacture date (29 Oct 2013)
- Purity test date: 14th January, 2014
- Appearence: Liquid, brown-green

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature (15 to 30 °C)
- Stability under test conditions: Stable at room temperature. Can oxidize in presence of oxygen at high temperatures.

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Water accommodated fractions were prepared by adding 0, 0.00035, 0.0007, 0.0014, 0.0028, and 0.0056 g of the test substance to 3.5L of dilution water to create a blank control, and nominal concentration rates of 0.1, 0.2, 0.4, 0.8 and 1.6 mg/L. Each WAF concentration was stirred for 48 hours (gradual increase to 250 rpm), after which the solution was allowed to settle for 1 hour. The vessels containing the solution were wrapped in foil and covered with plexiglas lids during the stirring. The solutions were then siphoned from the center of the water column, with the first ~100 mL discarded.

- Controls: Laboratory blank and WAF control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All solutions were clear and colorless after siphoning.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: In house culture. Original stock from Aquatic BioSystems (Ft. Collins CO)
- Feeding during test: No, neonates fed ca. 1.0 mL of P. subcapitata before test

ACCLIMATION:
- Acclimation period: None, organisms were <24 hours old
- Rearing conditions: Same as test
- Food type: Pseudokirchineriella subcapitata and yeast-cereal-grass fermented-trout-chow (YCT).
- Amount: 2.5 mL each of P. subcapitata and YCT.
- Frequency: 3 times weekly.
- Health during acclimation of parental stocks (any mortality observed): 1.6% mortality in 7 days preceding test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

92 mg/L CaCO3

Test temperature:

18.7 - 20.2 °C

pH:

7.9 - 8.2

Dissolved oxygen:

9.0 - 9.4 mg/L

Conductivity:

321-336 uS/cm

Nominal and measured concentrations:

Concentrations: Nominal- Lab water blank, WAF blank, 0.1, 0.2, 0.4, 0.8, 1.6 mg/L (prepared as Water Accomodated fractions)

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass beakers covered with Plexiglas
- Test solution volume: 200 mL
- Aeration: None. Test water was vigorously aerated with filtered oil-free compressed air passed through a glass Pasteur pipette before use.
- No. of organisms per vessel: Five
- No. of vessels per concentration (replicates): Four
- No. of vessels per control (replicates): Four
- No. of vessels per procedural control (replicates): Four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Water with additional of: MgSo4 (0.0572 g/L), CaSO4*H2O (0.0835 g/L), NaHCO3 (0.1056 g/L), KCl (0.0044 g/L), Vitamin B12 (2 ug/L), Selenium (2 ug/L).
- Ca/mg ratio: 1.0
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16h light:8h dark, 30 minute transition period
- Light intensity: 590-618 lux, full spectrum

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Observations for general behavior (immobilization) were measured at test initiation, 24 and 48 hours during the test.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2-fold
- Range finding test: Yes
- Test concentrations: 0, 0.1, 1, 10, 100 Test Item/L.
- Results used to determine the conditions for the definitive study: 0 daphnia dead at 0.1 mg/L, total mortality at 1.0 mg/L

Reference substance (positive control):

yes

Remarks:

Zinc Sulfate Heptahydrate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

0.57 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other:

Remarks:

95% CI: 0.32, 0.96 mg/L

Details on results:

- Behavioural abnormalities: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: No. Solutions appeared clear and colorless at beginning and end of test

Results with reference substance (positive control):

- Results with reference substance valid? yes
48 hour LC50=0.58 mg Zn2+/L
- Other: refernce substance test initiated one day prior to definitive test

Reported statistics and error estimates:

Statistical evaluations were performed on immobilization of Daphnia magna using a Binomial method. The values were calculated using the CETIS statistical package (Version 1.7.0.3).

Table 1. Daphnia Magna Immobilization in 48 hr Exposure

Nominal loading rate (mg/L)	Mean ± SD (%)	Replicate A (# / %)	Replicate B (# / %)	Replicate C (# / %)	Replicate D(# / %)
Lab Control	0 ± 0	0 / 0	0 / 0	0 / 0	0 / 0
WAF control	0 ± 0	0 / 0	0 / 0	0 / 0	0 / 0
0.1	0 ± 0	0 / 0	0 / 0	0 / 0	0 / 0
0.2	0 ± 0	0 / 0	0 / 0	0 / 0	0 / 0
0.4	0 ± 0	0 / 0	0 / 0	0 / 0	0 / 0
0.8	100 ± 0	5 / 100	5 / 100	5 / 100	5 / 100
1.6	100 ± 0	5 / 100	5 / 100	5 / 100	5 / 100

 

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%), DO >3 mg/L (9 mg/L)

Conclusions:

48 hour EL50 of 0.57 mg/L (OECD 202) in Daphnia magna for immobilization.

Executive summary:

The 48 hour EL50 of MTDID 18990 to Daphnia magna was determined according to OECD 202 guidelines. Nominal concentrations of 0.1, 0.2, 0.4, 0.8, and 1.6 mg/L (prepared as Water Accommodated Fraction), a laboratory control, and a WAF control were run using 5 animals per vessel, with four replicates per concentration. An EL50 of 0.57 mg/L was determined.

The study was well-documented, followed an international standard method, but was not GLP compliant and had no analytical monitoring of test substance. The study is considered reliable with restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.

Description of key information

48 hour EL50 of 0.57 mg/L (OECD 202) in Daphnia magna for immobilization.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.57 mg/L

Additional information

The 48 hour EL50 of MTDID 18990 to Daphnia magna was determined according to OECD 202 guidelines. Nominal concentrations of 0.1, 0.2, 0.4, 0.8, and 1.6 mg/L (prepared as Water Accommodated Fraction), a laboratory control, and a WAF control were run using 5 animals per vessel, with four replicates per concentration. An EL50 of 0.57 mg/L was determined.

The study was well-documented, followed an international standard method, but was not GLP compliant and had no analytical monitoring of test substance. The study is considered reliable with restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.