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

Short-term toxicity to fish

Administrative data

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04th-08th February, 2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

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: 14 Jan 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 if exposed to oxygen at high temperatures.

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION :
Water accomodated fractions were prepared by adding 0, 0.005, 0.01003, 0.02001, 0.04003, and 0.08002 g of the test substance to 8L of dilution water to create a blank control, and nominal concentration rates of 0.625, 1.25, 2.5, 5 and 10 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. All solutions were clear and colorless after siphoning.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Source: Aquatic Biosystems, Fort Collins, Colorado, USA
- Age at study initiation (mean and range, SD): 2.5 months (hatch date 11th-22nd November, 2013)
- Length at study initiation: 1.7 ± 0.2 cm; 1.5 to 2.0 cm
- Weight at study initiation: 0.04 ± 0.01g; 0.03 to 0.06 g

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: Fish were held under conditions as described in the Maxxam SOP "Fathead Minnow 7 Day Survival and Growth Test (Environment Canada)" . The conditions are similar to the quality of the test water.
- Health during acclimation: In good health and free from malformations. 0.7% mortality reported.

FEEDING DURING TEST : No feeding during test

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

132 mg/L (CaCO3)

Test temperature:

21.5 - 22.7 °C

pH:

7.8 - 8.5

Dissolved oxygen:

7.5 - 9.0 mg/L

Conductivity:

462-465 uS/cm

Nominal and measured concentrations:

Nominal: Lab water blank, WAF blank, 0.625, 1.25, 2.5, 5, 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 9L glass jars closed with Plexiglas covers
- Material, size, headspace, fill volume: 6L fill volume
- Aeration: None. Test water was vigorously aerated with filtered oil-free compressed air passed through an airstone prior to use.
- No. of organisms per vessel: Seven
- No. of vessels per concentration (replicates): One
- No. of vessels per control (replicates): One
- Biomass Loading rate: 0.05 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: moderately hard reconstituted water
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: 16h light:8h dark, 30 minute transition period
- Light intensity:309-361 lux at water surface , full spectrum
- Adjustment of pH: None

EFFECT PARAMETERS MEASURED : Observations for mortality and other sub-lethal effects such as behavior and physical appearance were measured by observation at test initiation, 24, 48, 72 and 96 hours during the test.

TEST CONCENTRATIONS
- Spacing factor for test concentrations:2-fold
- Range finding test: Yes
- Test concentrations: 0, 0.1, 1, 10 and 100 mg test item/L.
- Results used to determine the conditions for the definitive study: No mortality a 1 mg/L, total mortality at 10 mg/L

Reference substance (positive control):

yes

Remarks:

Phenol

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

2.16 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CI: 1.7, 2.73 mg/L

Details on results:

- Behavioural abnormalities: 2 fish were lying near the bottom of the tank on day 3 at exposure concentration of 2.5 mg/L. On day 4, 1 additional fish had died but others appeared normal.
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: Solutions appeared clear and colorless at beginning and end of test

Results with reference substance (positive control):

- Results with reference substance valid? yes
- 96 hour LC50=28 mg/L
- Other: reference substance test initiated one week after chemical substance test

Reported statistics and error estimates:

Statistical analyses were performed on mortality of larval fish using Spearman-Karber statistical procedure. The values were calculated using the CETIS stattistical package (Version 1.7.0.3).

Sublethal observations / clinical signs:

Table 1. Fathead Minnow Mortality in 96 hr Exposure (Cumulative)

Nominal loading rate (mg/L)	24 hours (# / %)	48 hours (# / %)	72 hours (# / %)	96 hours (# / %)
Lab Control	0 / 0	0 / 0	0 / 0	0 / 0
WAF control	0 / 0	0 / 0	0 / 0	0 / 0
0.625	0 / 0	0 / 0	0 / 0	0 / 0
1.25	0 / 0	0 / 0	0 / 0	0 / 0
2.5	0 / 0	3 / 42.9	4 / 57.1	5 / 71.4
5	7 / 100	7 / 100	7 / 100	7 / 100
10	7 / 100	7 / 100	7 / 100	7 / 100

 

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%), DO >60% ASV (87%-102%)

Conclusions:

96 hour LL50 of 2.16 mg/L (OECD 203) in Pimephales promelas.

Executive summary:

The 96 hour LL50 of MTDID 18990 to Pimephales promelas was determined according to OECD 203 guidelines. Nominal concentrations of 0.625, 1.25, 2.5, 5, and 10 mg/L (prepared as Water Accommodated Fraction), a laboratory control, and a WAF control were run using 7 animals per tank, with one replicate per concentration. An LL50 of 2.16 mg/L (measured concentration) 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

96 hour LL50 of 2.16 mg/L (OECD 203) in Pimephales promelas.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2.16 mg/L