Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates

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:

28-02-2012 to 24-03-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conform guideline and under GLP, the test was performed as WAF

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Principles of method if other than guideline:

The test was perfomed on a water accomodated fraction (WAF)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates

EC Number:

806-509-1

Cas Number:

1393571-42-0

Molecular formula:

NA

IUPAC Name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates

Constituent 2

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates

IUPAC Name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates

Test material form:

other: extremely viscous liquid

Details on test material:

- Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: at 0 and 48 h; in the pre-test at 0, 10 and 100 mg/L, in the final test at 0 and 100 mg/L
- Sample storage conditions before analysis: at -20 °C

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stirring for 23 hours, standing 1 hour and transfer via tube by mid depth syphoning
- Differential loading: pre-test 10 and 100 mg/L; final test 100 mg/L
- Controls: untreated
- Evidence of undissolved material: microscopic evaluation did not show any undissolved material in the WAF

The mixing time was validated in a separate test where extension of the mixing period to 96 hours did not improve the final measured concentrations (at 100 mg/L loading rate : 24 h 32.38 mg/L, 96 h 43.52 mg/L)

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: < 24 hours
- Feeding in culture: algae suspension and tetramin flake food suspension

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

22 °C

pH:

7.9-8.1

Dissolved oxygen:

8.7-9.0 mg/L (100-103% of saturation)

Nominal and measured concentrations:

nominal: 0, 100 mg/L (loading rate)
measured

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL
- Type: covered
- Fill volume: 200 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (according to guidance)
- Alkalinity: pH 7.8 ± 0.2
- Ca/mg ratio: 4/1
- Conductivity: 5 uS
- Culture medium different from test medium: Elendt M7
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16/8
- Light intensity: 611-653 Lux

EFFECT PARAMETERS MEASURED : immobilization

TEST CONCENTRATIONS
- Range finding study: 0, 10, 100 mg/L as loading rate
- Test concentrations: 0, 100 mg/L as loading rate

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 other: mg/L as loading rate

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The analysed concentration was < LOQ for all test concentrations

Results with reference substance (positive control):

48h EC50 1.1 mg/L within expected range

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance did not induce immobility in Daphnia magna at a loading rate of 100 mg/L

Executive summary:

Daphnids were exposed to 0 and 100 mg/L test substance during 48 hours. No immobility was found. The analyses for accuracy of preparation at the maximum concentration attainable showed that the actual concentration was below the LOQ (0.054 mg/L).