Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 to 14 May 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Remarks:

Statement

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
n/a

Analytical monitoring:

no

Details on sampling:

n/a

Vehicle:

no

Details on test solutions:

Previous studies had identified the 48 hour EC50 as being approximately 100mg/L, therefore definitive test concentrations were prepared as 0 (control), 25, 50, 100, 200, 400 and 800 mg/L.
The PR-4758 is stated to contain 45% active monoethylene glycol, therefore two further controls were prepared containing 45mg/L and 360 mg/L ethylene glycol.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST SPECIES
Test organism: Daphnia magna
Source: Shell Research Laboratories
Date of gravid isolation: 11 May 2003
Age of daphnia at start of test: <24 hours
Culture conditions:
- Temperature: 20 +/- 1 deg C
- Dissolved oxygen: >60% ASV
- Photoperiod: 16 hours light and 8 hours dark
Feeding regime:
- Each working day a suspension of Chlorella vulgaris, at a rate of 1mg organic carbon per litre of culture water.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

231 mg/L CaCO3

Test temperature:

Temperature: 20 +/- 1 deg C

pH:

ph 7.0 - 8.0

Dissolved oxygen:

>60% ASV

Salinity:

n/a

Nominal and measured concentrations:

Nominal concentrations at 0 (control), 25, 50, 100, 200, 400 and 800 mg/L.

Details on test conditions:

For each test concentration five Daphnia were transfered in a minimum amount of culture water ( < 0.5 mL) into four test vessels (50 mL) with 25 mL of test solution. The four controls were prepared with 25 mL of dilution water. Aerial contamination and evapouration were limited by placing a trasparent perspex sheet over the tops of the test vessels. The pH, dissolved oxygen and temperature were measured prior to initiating the test and at the end of the test. (See details in Water Quality Table).

The number of immobilised Daphnia were recorded at 24 and 48 hours, and EC 50 values calculated using ToxCalc v5.

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

703 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI = 500-1418 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

105 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI = 79 - 138 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

There were no mortalities in the dilution water control, or the monoethylene glycol (PR-4758 solvent) control tests.

Results with reference substance (positive control):

n/a

Reported statistics and error estimates:

See summary table of effect concnetrations

Cumulative percent immobilisation

Concentration (mg/L)	Number immobilised		% immobilised
	24 hours	48 hours	24 hours	48 hours
Contol I (water)	0	0	0	0
Control II (MEG)	0	0	0	0
Control III (MEG)	0	0	0	0
25	0	0	0	0
50	0	5	0	25
100	0	12	0	60
200	2	15	10	75
400	7	17	35	85
800	10	20	50	100

Validity criteria fulfilled:

yes

Conclusions:

The 48 hour EC50 value for PR-4758 to Daphnia magna was 105 mg/L, and the 48 hour NOEC was 25 mg/L.
Allwater quality measurements were within acceptabel limits, and the water and solvent (MEG present in PR-4758) controls resulted in no mortalities, therefore the solvent present in PR-4758 does not contribute to the toxicity observed.

Executive summary:

Substance: PR-4758

Chemex reference: Sample: ECO040309; Study: ENV6432

Test species: Daphnia magna

Test type: Acute toxicity: 48 hour EC50

Test Conditions: Static test conditions according to SOP E201 based upon OECD 202 guideline

Test Period: 12 May to 14 May 2003

Test performed at: Chemex Environmental International Limited, Bar Hill Business Park, 37 Saxon Way, Bar Hill, Cambridge, CB3 8EL, UK

Results:

Period of Exposure (hours)	EC50Value (mg/L)	95 % Confidence Limits (mg/L)
24	703	500 - 1418
48	105	79 - 138

 

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 June 2002 to 05 July 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.

Qualifier:

according to guideline

Guideline:

other: ISO/CD 14669 and in accordance with PARCOM Ring Test Workshop 1990

Deviations:

no

GLP compliance:

yes

Remarks:

GLP Statement

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
n/a

Analytical monitoring:

no

Details on sampling:

n/a

Vehicle:

no

Details on test solutions:

Test substance was dissolved in filtered and aerated seawater. A stock solution was prepared at the highest test concentration of 54mg/L and test solutions of 2, 6 and 18 prepared from dilutions of the stock solution.

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

TEST SPECIES
Test organism: Acartia tonsa
Source: University of Copenhagen, Laboratory of Marine Biology, Helsingor, Denmark
Date organisms delivered to laboratory: 12 April 2002
Age of copepods at start of test: 16 day
Life stage: Adult

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

mortality only

Hardness:

no data

Test temperature:

18.0 - 19.6 deg C

pH:

no data

Dissolved oxygen:

no data

Salinity:

no data

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 2, 6, 18 & 54 mg/L

Details on test conditions:

Four replicates at four concentrations and four controls were tested. One test concentration (1.0 mg/L) of the reference substance 3,5-Dichlorophenol was also used.
A range finding test was not performed, but the definitive test concentrations selected based on the results from the Skeletonema costatum study results. The number of mortalities after 24 & 48 hours were recorded.

Reference substance (positive control):

yes

Remarks:

3,5-Dichlorophenol

Duration:

48 h

Dose descriptor:

LC10

Effect conc.:

29.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

31 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

other: LC90

Effect conc.:

32.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Test Validation Criteria:
- The dissolved oxygen concentration at the end of the test is greater then or equal to 4 mg/L
- The percentage lethality of the control is less than or equal to 10%
- The concentration of 1.0 mg/L 3,5-Dichlorophenol results in an effect between 20 and 80% lethality.
- The temperature has been in the range 20.0 deg C +/- 2.4 deg C

In this test the control parameters yielded the following values:
- DO concentration = 7.2 mg/L
- % Lethality of the control = 0%
- Lethality of 1.0 mg/L 3,5-Dichlorophenol = 75%
- Temperature variations during the test = 18.0-19.6 deg C

Test concentration and Mortality Table

Test Conc (mg/L)	Parallel	No. or organisims per vessel	Mortalities 24 hours	Mortalities 48 hours
Control	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
2	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
6	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
18	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
54	1	5	5	5
	2	5	5	5
	3	5	5	5
	4	5	5	5

Validity criteria fulfilled:

yes

Conclusions:

The 48 hour LC50 was 31.0 mg/L. 95% confidence interval could not be calculated. The NOEC value was 18 mg/L.

Executive summary:

A marine invertebrate 48 hour acute toxicity test was performed using the species Acartia tonsa, and the test substance PR-4758.

The control and reference substance validation criteria were met, and based on the four test concentrations employed the LC50 was calculated as 31.0 mg/L.

Description of key information

96 hour EC50 = 105 mg/L; OECD 202; WJ Craig (2003)

96 hour EC50 = 31 mg/L; ISO/CD 14669 and in accordance with PARCOM Ring Test Workshop 1990; Haug (2002)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

105 mg/L

Marine water invertebrates

Marine water invertebrates

Dose descriptor:

EC50

Effect concentration:

31 mg/L

Additional information

A key study for both freshwater and marine compartments is available. Both studies were conducted in accordance with international guidelines and GLP.