Isooctadecanoic acid, reaction products with tetraethylenepentamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 30, 1993 - February 16, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with the following OECD Method 203. Acceptable restriction was that analytical measurements on the test material were not conducted.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss
- Source: They were procured from Mount Lassen Trout Farm, Red Bluff, california on October 13, 1993.
- Age at study initiation (mean and range, SD): juvenile
At the end of the test, the control fish had an average total length of 34 mm and an average wet weight of 0.37g.
- Feeding during test: Fish were not fed during the test
- Food type: Were fed a dry commercial food (tetra Min Staple Food, Lot #TM 02)
- Frequency: They were fed daily except during the 48 hours immediately preceding the test

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not): During the 14 day period before the start of the test the acclimation temperature range was 11.3 to 12.9 degrees Celsius and the dissolved oxygen concentration was always at least 9.4 mg/L.
- Type and amount of food: During acclimation the fish were fed a dry commercial food (tetra Min Staple Food, Lot #TM 02)
- Feeding frequency: They were fed daily except during the 48 hours immediately preceding the test
- Health during acclimation (any mortality observed): Mortality during the final 48 hours of acclimation was less than 3%.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Water was adjusted to a hardness of 40 to 48 mg/L as CaCO3

Test temperature:

Target temperature of 12 +/- 1 degree Celsius

pH:

pH ranged from 7.4 to 7.9

Dissolved oxygen:

The mean dissolved oxygen concentration during the definitive test was 8.5 mg/L

Nominal and measured concentrations:

Nominal concentrations were 1, 10, 100 and 1000 mg/L administered as WAFs for the range finder. The definitive test used a concentration of 1000 mg/L (WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass mixing vessel with a magnetic stirrer
- Aeration: not required
- Renewal rate of test solution (frequency/flow rate):Daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used was dechlorinated tap water collected at Marblehead, Massachusetts.
- Total organic carbon: TOC at 0 mg/L (control) was 1mg/L at 0 and 24 hours for one replicate and not detected for the other replicate. TOC at 1000 mg/L (WAF) was 2 mg/L for both replicates at 0 and 24 hours.
- Pesticides: not detected above the reporting limit
- Alkalinity: 7 mg/L as CaCO3
- Conductivity: 200 umhos/cm
- Intervals of water quality measurement: Dissolved oxygen concentration, pH, conductivity and temperature were measured in each test vessel initially and at 24 hour intervals (before and after media renewal).

OTHER TEST CONDITIONS
- Adjustment of pH: pH ranged from 7.4 to 7.9
- Photoperiod: 16 hour light and 8 hour dark photoperiod
- Light intensity: 2 uEin-1m-2

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The number of surviving organisms and the presence of sublethal effects was determined visually and recorded initially and after 3, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: At the end of the 96 hour exposure there was 100% survival at all tested concentrations in the range finder.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Details on results:

- Behavioural abnormalities: One fish exposed to the 1,000 mg/L WAF was swimming eratically and gasping at 48 hours. No other sublethal effects were noted during the test
- Mortality of control: no mortalities in controls

Reported statistics and error estimates:

Statistical analysis of the survival data was not warranted because greater than 50% survival occurred at the highest tested concentration.

Validity criteria fulfilled:

yes

Conclusions:

The 24, 48, 72 and 96 hour rainbow trout LC50s are each greater than 1,000 mg/L (expessed as the nominal amount of test substance used to prepare the WAF) and the 96 hour NOEC is 1,000 mg/L.

Executive summary:

The acute toxicity of the water accomoodated fraction (WAF) of 1,000 mg/L mixtures of test material and water to the rainbow trout, Oncorhynchus mykiss, was investigated during a study conducted at T.R. Wilbury Laboratories, Inc. The test, which was designed to determine the toxicity of the WAF of the test substance, was performed from November 1 to 5, 1993.

The test was performed at 12 +/- 1 degree Celsius under static, renewal conditions with a control and the WAF of a 1,000 mg/L mixture of test substance and water. The dilution water was carbon filtered dechlorinated tap water collected at Marblehead, Massachusetts and adjusted to a hardness of 40 to 48 mg/L as CaCO3. Juvenile rainbow trout used for the test were procured from a commercial supplier and acclimated to test conditions for at least 14 days prior to use in the test.

The WAF was prepared by formulating a 1,000 mg/L solution of test material in dilution water and placing it in a glass mixing vessel equipped with a magnetic stirrer. The mixture was stirred for approximately 24 hours, settled for approximately 1 hour, and the water phase containing the WAF was siphoned off. Approximately 80% of the media was renewed in each test vessel after 24, 48, and 72 hours using a freshly prepared WAF. Non-control test vessels were slightly cloud throughout the test. No other insoluble material was noted in test vessels containing test material.

The WAF of the test substance was not toxic to rainbow trout at the tested concentration. The 96 hour median lethal concentration (LC50) of test material to rainbow trout is greater than 1,000 mg/L (expressed as the nominal amount of test substance used to prepare the WAF) and the no observed effect concentration (NOEC) is 1,000 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 December 1992 to 19 December 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

EPA OTS 797.1400 (Fish Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
Test concentrations used during the study were prepared by weighing appropriate amounts of test material and mixing into the vortex created in the dilution water inside the mixing cylinder in each test chamber. Test solutions were prepared and mixed approximately 30 to 60 minutes prior to the addition of the test organisms, and renewed after approximately 48 hours.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow.
- Source: obtained from cultures maintained at the testing facility.
- Age at study initiation: juvenile.
- Length (mean and range): 27 mm (24 - 30 mm), measured at the end of the study in 10 control fish.
- Weight (mean and range): 0.31 g (0.23 - 0.41 g), measured at the end of the study in 10 control fish.
- Feeding during test: no.


ACCLIMATION
- Acclimation period: 14 day holding period followed by 75 hour acclimation period.
- Acclimation conditions: same as test.
- Type and amount of food: flaked fish food, artemia nauplii, and frozen brine shrimp.
- Feeding frequency: fish were fed from hatch until approximately 75 hours prior to test initiation. Feed was withheld during the study.
- Health during acclimation (any mortality observed): no mortalities occurred during acclimation, and the fish showed no signs of disease or stress.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Test termination following 96 hour exposure period.

Hardness:

140 - 144 mg/L (as CaCO3)

Test temperature:

20.6 - 23.0 ºC

pH:

8.4 - 8.8

Dissolved oxygen:

8.3 - 9.0 mg O2/L

Nominal and measured concentrations:

0, 130, 216, 360, 600, 1000 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: 60 L glass aquaria.
- Fill volume: 40 L
- Type: within each test chamber a slotted PVC cylinder extended from the surface of the water to the bottom of the aquarium. An electric mixer able to run at approximately 1000 rpm was mounted above each PVC cylinder with a mixing shaft extending into the centre of the cylinder. The slots in the PVC cylinders were covered with a polyethylene screen to protect the fish from the mixing shafts.
- Aeration: test solutions were stirred during the study.
- Renewal rate of test solutions: test solutions were renewed 48 hours after study initiation.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): duplicate
- No. of vessels per vehicle control (replicates): duplicate
- Biomass loading rate: 0.08 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: freshwater obtained from a well 45 m deep located on the Wildlife International Ltd. site. The well water was passed through a sand filter to remove particles greater than ~ 25 µm, and pumped into a 37,800 L storage tank where the water was aerated with spray nozzles. Prior to delivery to the diluter system, the water again was filtered to remove microorganisms and particles.
- Total organic carbon: 1.0 mg/L
- Alkalinity: 190 mg/L (as CaCO3)
- Conductivity: 331 µmhos/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark with 30 minute transition period from light to dark and vice versa.
- Light intensity: 1184 lux (1076 - 1292 lux) provided by fluorescent tubes that emitted wavelengths similar to natural sunlight.

EFFECT PARAMETERS MEASURED: observations of mortality and other clinical signs of toxicity were at approximately 24, 48, 72 and 96 hours after test initiation.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

600 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Water Parameters
Water temperatures, taken daily, ranged from 20.6 to 23.0 ºC. Dissolved oxygen and pH readings ranged from 8.3 to 9.0 mg/L and 8.4 to 8.8, respectively. Dissolved oxygen concentrations exceeded 60% of saturation throughout the test. Conductivity, alkalinity, and hardness measured at test initiation (0 hours) in the control replicate were 335 µmhos/cm, 190 mg/L as CaCO3, and 144 mg/L as CaCO3, respectively. At test termination (96 hours) conductivity, alkalinity and hardness were 330 µmhos/cm, 190 mg/L as CaCO3, and 140 mg/L as CaCO3, respectively.

- Test Solutions Observations
After the test material was added to the vortex, a white, cloudy suspension was formed in the test chambers. The degree of cloudiness increased directly with treatment level. By the 24 hour observation, a white floc was observed floating on the water’s surface, which also increased directly with treatment level.

- Biological Observations
Fish in the control and 130, 216 and 360 mg/L test solutions appeared normal and healthy throughout the test. At 600 mg/L, no mortality was observed but lethargy and hemorrhaging were noted at 72 and 96 hours, respectively. While one fish was noted hemorrhaging at the 600 mg/L concentration, this observation was not concentration-dependent and may not have been treatment-related. At the 1000 mg/L treatment level, 15% of the fish were dead after 96 hours. Signs of toxicity observed at the 1000 mg/L treatment level included lethargy, erratic swimming and surfacing.

Sublethal observations / clinical signs:

Table 1: Cumulative Percent Mortality and Treatment-Related Effects

Nominal conc. (mg/L)	Replicate	24 hours		48 hours		72 hours		96 hours		Cumulative Percent Mortality
		Mortality	Effects	Mortality	Effects	Mortality	Effects	Mortality	Effects
Control	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/20)
	B	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN
130	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/20)
	B	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN
216	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/20)
	B	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN
360	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/20)
	B	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN
600	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	1C, 9AN	0% (0/10)	1H, 9AN	0% (0/20)
	B	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	10 AN
1000	A	0% (0/10)	10 AN	0% (0/10)	10 AN	0% (0/10)	1C, 9AN	0% (0/10)	10 AN	15% (3/20)
	B	0% (0/10)	10 AN	20% (2/10)	1C, 7AN	20% (2/10)	1E, 7AN	30% (3/10)	1A, 6AN

Observed Effects:

A = surfacing

C = lethargy

H = hemorrhaging

E = erratic swimming

AN = appears normal

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study, the 96 hour LC50 value for fathead minnow exposed to the test material was determined to be greater than 1000 mg/L, the highest concentration tested, and the LC0 was determined to be 600 mg/L. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The acute toxicity of the test material to fish was investigated in Pimephales promelas (fathead minnow) in accordance with standardised guidelines EPA OTS 797.1400 and OECD 203. During the test the fish were exposed to the test material at nominal test concentrations of 0, 130, 216, 360, 600 and 1000 mg/L, under static renewal conditions, for a 96 hour exposure period. Under the conditions of the study, fish in the control and 130, 216 and 360 mg/L test solutions appeared normal and healthy throughout the test. At 600 mg/L, no mortality was observed but lethargy and hemorrhaging were noted at 72 and 96 hours, respectively. While one fish was noted hemorrhaging at the 600 mg/L concentration, this observation was not concentration-dependent and may not have been treatment-related. At the 1000 mg/L treatment level, 15% of the fish were dead after 96 hours. Signs of toxicity observed at the 1000 mg/L treatment level included lethargy, erratic swimming and surfacing. Based on the results on mortality and the treatment-related observations, the 96 hour LC50 was determined to be greater than 1000 mg/L, the highest concentration tested and the LC0 was determined to be 600 mg/L.

Description of key information

Based on results from two reliable OECD 203 tests, EC 701-204-9 has an LC50>1000 mg/L and would not be classified as harmful to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

1 000 mg/L

Additional information

Two reliable studies were available to evaluate the acute toxicity of the registered substance to fish.

In the Martin et al., 1993 study, the acute toxicity of the test material to fish was investigated in Pimephales promelas (fathead minnow) at nominal test concentrations of 0, 130, 216, 360, 600 and 1000 mg/L, under static renewal conditions, for a 96 hour exposure period. Under the conditions of the study, fish in the control and 130, 216 and 360 mg/L test solutions appeared normal and healthy throughout the test. At 600 mg/L, no mortality was observed but lethargy and hemorrhaging were noted at 72 and 96 hours, respectively. While one fish was noted hemorrhaging at the 600 mg/L concentration, this observation was not concentration-dependent and may not have been treatment-related. At the 1000 mg/L treatment level, 15% of the fish were dead after 96 hours. Signs of toxicity observed at the 1000 mg/L treatment level included lethargy, erratic swimming and surfacing. Based on the results on mortality and the treatment-related observations, the 96 hour LC₅₀ was determined to be greater than 1000 mg/L. This study was selected as the key study because it was performed in line with GLP and according to an accepted standardised guideline and was assigned a reliability score of 1.

In the Ward et al., 1994 study, the acute toxicity of test material at a concentration of 1,000 mg/L (WAF) was evaluated in Oncorhynchus mykiss (rainbow trout) under static, renewal conditions. One fish exposed to the 1,000 mg/L WAF was swimming eratically and gasping at 48 hours. No other sublethal effects were noted during the test and the 96 hour median lethal concentration (LC₅₀) was determined to be greater than 1,000 mg/L (expressed as the nominal amount of test substance used to prepare the WAF) and the no observed effect concentration (NOEC) is 1,000 mg/L. This study was also conducted according to GLP and according to accepted standardised guidelines, but was given a Klimisch rating of 2. Acceptable restriction was that analytical measurements on the test material were not conducted.