Asphalt, sulfonated, sodium salt

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-07-01 to 2002-07-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Guideline 203, modified to marine conditions, and GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Only three test concentrations used (due to lack of toxicity); modified for marine species.

Principles of method if other than guideline:

N/A

GLP compliance:

yes

Remarks:

statement, no certificate

Test material

Test material information

Constituent 1

Reference substance name:

Soltex additive

IUPAC Name:

Soltex additive

Constituent 2

Reference substance name:

Soltex Additive contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)

IUPAC Name:

Soltex Additive contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)

Details on test material:

- Name of test material (as cited in study report): Soltex Additive
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: dark brown to black powder
- Analytical purity: N/A
- Impurities (identity and concentrations): N/A
- Composition of test material, percentage of components: Soltex Additive contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)
- Isomers composition: N/A
- Purity test date: not known. Sample tested as supplied by client
- Lot/batch No.: N/A
- Expiration date of the lot/batch: N/A
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: Test substance supplied by Drilling Specialties Company.

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

N/A

Test solutions

Vehicle:

no

Details on test solutions:

Water accommodated fractions prepared per methods described in OSPAR 1995. Soltex Additive was prepared in dilution water, shaken vigorously, and allowed to stand for 4 hours. A cloudy dark brown solution with neutrally buoyant material was observed. For each nominal concentration, the required amount of homogenized sample was added to 12 L of dilution water (artificial seawater), mixed for 20-24 hours, allowed to separate for 4 hours, and filtered using a 0.63 micron sieve. The filtrate was used to prepare the test solutions, which were 560, 1000, and 1800 mg/L nominal. It was observed that more test material settled during the test from 24 hours onward. The dissolved concentrations were likely to be lower than the nominal concentrations as Soltex Additive was poorly soluble in water.

Test solutions were replaced at 48 hours (semi-static exposure).

Test organisms

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: Turbot
- Strain: N/A
- Source: France Turbot, Noirmountiers, France
- Age at study initiation (mean and range, SD): N/A
- Length at study initiation (length definition, mean, range and SD): N/A
- Weight at study initiation (mean and range, SD): N/A
- Method of breeding: Purchased from supplier
- Feeding during test
- Food type: N/A
- Amount: N/A
- Frequency: N/A


ACCLIMATION
- Acclimation period: 06-06-2002 to 07-01-2002
- Acclimation conditions (same as test or not): 13.5 to 14.5 deg. C; Dissolved oxygen: >95% ASV ; same as test
- Type and amount of food: N/A
- Feeding frequency: N/A
- Health during acclimation (any mortality observed): N/A


QUARANTINE (wild caught)
- Duration: N/A
- Health/mortality: N/A

Study design

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

N/A

Test conditions

Hardness:

N/A

Test temperature:

Initial-14.0 deg C
Range-14.0-15.0 deg C

pH:

Initial-8.1
Range-8.2-8.4

Dissolved oxygen:

Initial-99% ASV
Range-96-100% ASV

Salinity:

Tests were performed in artificial seawater (Tropic Marin). The measured salinity of the seawater used was 31 to 35 g/L sodium chloride.

Nominal and measured concentrations:

Nominal-Control (0), 560, 1000, and 1800 mg/L (based on a preliminary study which identified the LC50 as > 1000 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel: aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 10 L test solution
- Aeration: - N/A
- Type of flow-through (e.g. peristaltic or proportional diluter): N/A
- Renewal rate of test solution (frequency/flow rate): at 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): N/A
- Biomass loading rate: N/A


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tropic Marin artificial seawater
- Total organic carbon: N/A
- Particulate matter: N/A
- Metals: N/A
- Pesticides: N/A
- Chlorine: N/A
- Alkalinity: N/A
- Ca/mg ratio: N/A
- Conductivity: N/A
- Culture medium different from test medium: no
- Intervals of water quality measurement: N/A


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: N/A


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, 24 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: <2
- Justification for using less concentrations than requested by guideline: in the interest of good fish management, since a preliminary study showed low toxicity to turbot
- Range finding study
- Test concentrations: Mentioned, but no details given.
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: no CL

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: no CL

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

1 672 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL = 1194 to 2342 mg/L

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1 672 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 96% CL= 1194-2342 mg/L

Details on results:

N/A
- Behavioural abnormalities: N/A
- Observations on body length and weight:At end of test 10 fish were measured-Mean length: 43.5 mm -Mean weight: 2.13 g
- Other biological observations: N/A
- Mortality of control: None
- Other adverse effects control: N/A
- Abnormal responses: N/A
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test substance was only partially soluble in water, and the test solution was filtered before use. Precipitation occurred at 24 h onward.
- Effect concentrations exceeding solubility of substance in test medium: N/A

Results with reference substance (positive control):

N/A

Reported statistics and error estimates:

LC50 values and 95% confidence limits were calculated using ToxCalc version 5.0. NOEC and LOEC were determined using Fisher's Exact test.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1.Cumulative percent mortality results:

Exposure Period (hours)	Control	560 mg/L	1000 mg/L	1800 mg/L
0	0	0	0	0
24	0	0	0	0
48	0	0	0	14.3
72	0	0	0	57.1
96	0	0	0	57.7

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

sufficient survival in controls

Conclusions:

The 96 hr LC50 of the test substance to turbot was found to be 1672 mg/L, with 95% confidence limits of 1194-2342 mg/L.

Executive summary:

N/A