Amides, mixed C16-18 and C18-unsatd. branched and linear and tall-oil fatty, N,N'-(iminodi-2,1-ethanediyl)bis-, maleated

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Principles of method if other than guideline:

In view of the low solubility of the substance a water accomodated fraction was tested

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid

EC Number:

700-795-0

Cas Number:

1393571-43-1

Molecular formula:

NA

IUPAC Name:

Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid

Test material form:

other: extremely viscous liquid

Details on test material:

test substance identification: Fatty acids, tall-oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid
Description : dark amber coloured extremely viscous liquid

Specific details on test material used for the study:

Physical state/Appearance: Dark amber colored solid block
Batch: Development sample 15-11-1
Storage Conditions: Room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/L
- Sampling: duplicate samples from fresh solutions on day 0, 5, 9, 14 and 19 and from old solutions on day 2, 7, 12, 16 and 21 of all replicates (analyses on pooled replicate samples)
- Sample storage conditions before analysis: frozen

Test solutions

Vehicle:

no

Details on test solutions:

- Pre-treatment: prior to weighing the substance was heated for30 min to 3 hours at 70°C
- Method: stirring for 23 hours, standing 1 hour and transfer via tube by mid depth syphoning
- Differential loading: 100 mg/L (500 mg in 5L water)
- Controls: untreated
- Evidence of undissolved material: microscopic evaluation did not show any microdispersions or undissolved material in the WAF

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory culture
- Age of parental stock : <24 hours
- Feeding during test: daily to achieve 0.1-0.2 mg C/daphnid/day
- Food type: algae suspension ( 5 to 10 µL) and Tetramin® flake food suspension (20 µL)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Remarks on exposure duration:

according to the guideline

Test conditions

Hardness:

250-270 as mg/L CaCO3

Test temperature:

21-22 °C

pH:

7.7-8.1

Dissolved oxygen:

8.3-9.0 mg/L (>93% of saturation)

Nominal and measured concentrations:

nominal 0 and 100 mg/L
measured:

Details on test conditions:

TEST SYSTEM
- Test vessel: 150 mL glass vessel containing 100 mL test medium
- Type: closed
- Aeration: none
- Renewal rate of test solution: on day 0. 2, 5, 7, 9, 12, 14, 16 and 19.
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (Elendt M7 medium)
- pH medium: 7.9 ± 0.3

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 light/ 8 dark
- Light intensity: 571 to 691 lux

EFFECT PARAMETERS MEASURED :
daily mortality parental daphnids; number of F1 daphnia and (discarded) unhatched eggs
at renwals: number of young daphnids (live and dead) and unhatched eggs as saved on the mesh

TEST CONCENTRATIONS
- Range finding study: the results were not evaluated, test substance concentration can be based on the outcome of the acute daphnia test
- Test concentrations: 0 and 100 mg/L

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Remarks:

loading rate

Basis for effect:

reproduction

Remarks:

and immobilisation

Effect concentrations 2

Key result

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Remarks:

loading rate

Basis for effect:

immobilisation

Effect concentrations 3

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Remarks:

loading rate

Basis for effect:

reproduction

Effect concentrations 4

Duration:

21 d

Dose descriptor:

EL10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Remarks:

loading rate

Basis for effect:

morphology

Remarks:

length

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight: no treatment related effects (day 21 control 3.8 mm, 1000 mg/L 4.1 mm)
- Mortality of control: 0
- First young: day 9 in controld and 100 mg/L

Reported statistics and error estimates:

t-test showed no statistically significant differences (P≥ 0.05) between the control and the 100 mg/L regarding length and number of young produced.

Any other information on results incl. tables

 

Nominal Loading Rate (mg/L)	Total Number of Live Young	Percentage Survival of Parental (P) Generation	Number of Live Young Per Parent Surviving to the End of the Test
control	1237	100	124
100	1278	100	128

 

No parental accidental and inadvertent mortalities reported

 

There were no unhatched eggs or dead young in any of the control or treatment groups. There were no visible differences in condition between young in the treatment and control groups.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The substance did not affect immobility and reproduction of daphnia exposed at 100 mg/L. The NOELR/EL10 is 100 mg/L

Executive summary:

Daphnids were exposed to 0 and 100 mg/L test substance during 21 days. Renewal of the test solutions was done 3 times weekly. No immobility was found or other adverse effects on the parental daphnids. Reproduction was comparable between the treated and control daphnids. The analyses for accuracy of preparation at the maximum concentration attainable showed that the actual concentration was below the LOQ (0.021 mg/L).

The NOELR is 100 mg/L.