Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept. 6, 1996-Dec. 9, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations
- Sample storage conditions before analysis: If samples could not be analysed the day they were taken, they were stored at 4°C and extracted at the earliest opportunity. Samples were stable for up to 7 days.
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance was added to measured volumes of test medium. The vessels were then sealed, leaving a small headspace, and the contents stirred with a 1-2 cm vortex depth until the aqueous and test substance phases equilibrated (45 hrs). The vessels were then allowed to settle for 1-1.5 hrs and the aqueous phase drawn off for use in the test as a Water Accomodated Fraction (WAF). Control media was treated in the same manner.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Strauss
- Source: clonal laboratory culture derived from animals obtained from Zeneca Brixham Laboratory
- Age at study initiation (mean and range, SD): less than 24 hrs
- Method of breeding: Cultures started with animals less than 24 hours old, and discarded when 28 days old. Young are removed daily, and animals for testing removed 23 hours after last removal. Test young are from 15-28 day cultures from at least the third brood.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
173 mg/l CaCO3
Test temperature:
19.4-19.7°C
pH:
7.7-7.9
Dissolved oxygen:
8.0-8.7
Nominal and measured concentrations:
Nominal loading rate: 0, 1, 2.2, 4.6, 10, 22, 46, 100 mg/l
Mean concentration of hydrocarbons: <0.05, 0.18, 0.83, 0.85, 1.7, 2.8, 4.7, 7.3 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: sealed with a screw cap
- Material, size, headspace, fill volume: 150 ml Erlenmeyer flasks completely filled
- Renewal rate of test solution (frequency/flow rate): static
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reverse osmosis filtered water with the following Analar grade salts added: NaHCO3 192 mg/l, CaSO4.2H2O120 mg/l, MgSO4.7H2O 240 mg/l, KCl 8 mg/l

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization

TEST CONCENTRATIONS
- Range finding study: Range finding test was conducted similar to the main study except chemical analysis was not done.
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
10 - 22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
22 - 46 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
other: NOEL
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: None

Number of Immobilized Daphnia magna

Loading Rate (mg/l)

24 hrs

48 hrs

0

0

0

0

0

0

1

0

0

1

0

0

2.2

0

0

2.2

0

0

4.6

0

0

4.6

0

0

10

0

0

10

0

1

22

3

6

22

1

8

46

10

10

46

10

10

100

10

10

100

10

10

Validity criteria fulfilled:
yes
Conclusions:
The 48-hr EL50 range for an invertebrate, Daphnia magna, was 10-22 mg/L (WAF).
Executive summary:

The purpose of this experiment was to determine the acute toxicity of low aromatic white spirits to Daphnia magna. 10 daphnia per test vessel (2 test vessels per concentration) were exposed to loading rates of 0, 1, 2.2, 4.6, 10, 22, 46, or 100 mg/l (WAF) of test substance. The exposure lasted for 48 hrs, and there was no renewal of test solution. At 24 and 48 hrs, the Daphnia were observed for immobilization. Immobilization was seen at test concentrations of 10 mg/l (WAF) and above, with immobilization of all daphnids at the 46 and 100 mg/l concentrations by the 24 hr observation. The 48-hr EL50 range for an invertebrate, Daphnia magna, was 10-22 mg/L (WAF).

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept. 6, 1996-Dec. 9, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations
- Sample storage conditions before analysis: If samples could not be analysed the day they were taken, they were stored at 4°C and extracted at the earliest opportunity. Samples were stable for up to 7 days.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Water accomodated fractions of Shellsol H were produced by stirring water appropriate to the test organisms and Shellsol H for 45 hours, leaving the contents of the vessel to stand at least for 1 hour and running off the aqueous phase for use as the test medium.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Strauss
- Source: clonal laboratory culture derived from animals obtained from Zeneca Brixham Laboratory
- Age at study initiation (mean and range, SD): less than 24 hrs
- Method of breeding: Cultures started with animals less than 24 hours old, and discarded when 28 days old. Young are removed daily, and animals for testing removed 23 hours after last removal. Test young are from 15-28 day cultures from at least the third brood.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
156-190 mg/l CaCO3
Test temperature:
19-20°C
pH:
7.9-8.5
Dissolved oxygen:
8.4-10.8
Salinity:
Not applicable (freswater test)
Nominal and measured concentrations:
Nominal loading rate: 0, 10, 22, 46, 100, 220, 460, 1000 g/l.
Details on test conditions:
TEST SYSTEM
- Test vessel: sealed with a screw cap
- Material, size, headspace, fill volume: 150 ml Erlenmeyer flasks completely filled with WAF or dilution water (control)
- Renewal rate of test solution (frequency/flow rate): static
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water comes from two pumping stations (Highstead and controlled by the Mid Kent Water Company. The water is obtained from bore holes in the chalk of the North Downs. The only chemical treatment prior to its arrival in the laboratory is chlorination to 0.1 mg/l. In the laboratory, the water is filtered (PAL MDY 1001 Y400) to remove all particles larger than 15 µm (90% of particles greater than 10µm) and passed through activated carbon filters (Cuno model CT) to remove chlorine and organic conatminants. Both particle and activated carbon filter cartridges are renewed as recommended by the manufacturers. Heat exchange units (stainless steel and perspex) are used to adjust the temperature of the water.
- Intervals of water quality measurement: six months


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization

.
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
100 - 220 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
460 - 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: None
Validity criteria fulfilled:
yes
Conclusions:
The 48-hr EL50 range for an invertebrate, Daphnia magna, was 100-220 mg/L (WAF).
Executive summary:

The acute toxicity of water accomodated fractions (aqueous extrats) of Shellsol H has been determined to the crustacean zzoplakter Daphnia magna.

The test media were prepared by adding quantities of Shellsol H to culture medium appropriate to the test organisms and stirring in sealed vessels for 45 hours. The strirring period was demonstrated as being sufficient to ensure equilibration of the shellsol H and aqueous phases. After stirring the contents of the test vessels were left to settle for about 1 hour before drawing off the WAF for use as the test media in the toxicity tests.

The concentrations of dissolved hydrocarbons (derived from the shellsol H) in the test media was determined during the toxicit tests usig gas chromatography. The analyses showed that the concentration in the test media was <1%% of the loading rate. The reduction in the concentration of dissolved hydrocarbons in the test media during the test was ≤26%.

The acute toxicity to D. magna of water accomodated fractions of Shellsol H prepared at loading rates ranging from 10 to 1000 mg/l was determined in a 48 static toxicity test without renewal of the test media. The test was conducted in sealed test vessels. The 24 and 48 h EL50 values (loading rates resulting in mortality of 50% of the D. magna after 24 and 48 h exposure) were 460-1000 and 100 -220 mg/l respectively.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was given a reliability rating of 1 because it followed a standard test guideline, which describes a procedure to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was also conducted under GLP.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
EC L383 C2
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
An equilibration trial was performed to determine the time required for the components of the test substance to achieve maximum aqueous solubility. Five glass aspirators were each filled with 22L of main dechlorinated water, leaving a small headspace of air. The test substance was added to four of the vessels at a loading rate of 1000 mg/L, and the contents of the fifth aspirator served as the control. All five vessels were then sealed, and stirred as vigorously as possible without creating a dispersion in the sealed vessels, which contained a small headspace of air to permit stirring. After nominal stirring periods of 24, 48, 72, 96and 198 hours, the WAF solutions were allowed to settle for 1-3 hours, after which a sample of the aqueous layer was extracted and analyzed by GC/FID. The results of the equilibration study showed that equilibrium between the test substance components and the aqueous phase at a loading of 1 g/L was reached in about 72-96 hours.
Vehicle:
no
Details on test solutions:
Test solutions were prepared as water accommodated fractions (WAF). Control and dilution water were reconstituted fresh (hard) water. The nominal loading rates used to prepare the WAFS were based upon range-finding results. This included adding test substance to 15-16 liter glass aspirator bottles, which contained laboratory dilution water, that was filtered (15 um) through activated charcoal. The WAF was stirred for 93-96 hours as vigorously as possible without creating a dispersion in the sealed vessels, which contained a small headspace of air to permit stirring. After mixing, the WAFs were allowed to settle for one hour, after which the aqueous phase was removed for testing. Test vessels were sealed 150 ml erlenmeyer flasks with 10 daphnids per flask. Two replicates per treatment and control were used.
Test organisms (species):
Daphnia magna
Details on test organisms:
D. magna, less than 24 h old, were taken from a laboratory culture, which is derived from a strain obtained via Zeneca Brixham Laboratory from I.R. Ch.A. France. Young were collected from cultures aged between 14 and 28 days
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
no data
Test temperature:
Test temperature was 18.1-19 Deg C.
pH:
The pH ranged from 8.3 to 8.6 during the study.
Dissolved oxygen:
Dissolved oxygen was 9.2-9.3mg/L
Salinity:
freshwater
Nominal and measured concentrations:
WAF concentration (mg/L) of dissolved hydrocarbon (derived from test substance) as determined by GC/FID. Specific hydrocarbon isomers were not identified. Analytical results are based on mass attributable to the test material. Control concentration was <0.02 mg/L at all sampling intervals identified above.

Nominal Loading Measured concentration (mg/L)
(mg/L) time 0 48 hr Mean
100 0.31 0.19 0.24
220 0.31 0.28 0.29
460 0.30 0.31 0.30
1000 0.33 0.24 0.28
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EL0
Effect conc.:
>= 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No immobilization was observed in the control and any of the WAF treatments.

48-hr EL0 = 1000 mg/L based upon nominal loading rate

This value is representative of acute aquatic invertebrate toxicity for those C14-C20 (high aromatics) aliphatic category members having an initial minimum boiling point range of 263°C. Since the hydrocarbon constituents for these category members with boiling point values greater than 263 deg C do not show adequate water solubility in equilibrated aqueous solutions, acute aquatic toxicity effects are not expected at the 1000mg/L maximum loading concentration investigated in this study.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. Under the conditions of this study, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not produce acute toxicity to Daphnia magna at 1000 mg/l, based on nominal loading of the test substance in water.
Executive summary:

The acute toxicity of Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. Under the conditions of this study, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not produce acute toxicity to Daphnia magna at 1000 mg/l, based on nominal loading of the test substance in water.

Description of key information

There is no experimental data available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics. Data is read across from structural analogues such as Hydrocarbons, C9-C14 aliphatics, 2-25% aromatics and Hydrocarbons, C14-C20 aliphatic, 2-30% aromatics. Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

 

The acute toxicity of Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. 10 daphnia per test vessel (2 test vessels per concentration) were exposed to loading rates of 0, 1, 2.2, 4.6, 10, 22, 46, or 100 mg/L (WAF) of test substance. Immobilization was seen at test concentrations of 10 mg/L (WAF) and above, with immobilization of all daphnids at the 46 and 100 mg/L concentrations by the 24 hr observation. The 48-hr EL50 range for an invertebrate, Daphnia magna, was 10-22 mg/L (WAF).

 

The acute toxicity of Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. The 48-hr EL50 range for an invertebrate, Daphnia magna, was 100-220 mg/L (WAF).

 

The acute toxicity of Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. Under the conditions of this study, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not produce acute toxicity to Daphnia magna at 1000 mg/L, based on nominal loading of the test substance in water.

 

In a second study, the acute toxicity of Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), as measured by immobility to the water flea (Daphnia magna) was evaluated in freshwater. Under the conditions of this study, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not produce acute toxicity to Daphnia magna at 1000 mg/L, based on nominal loading of the test substance in water.

 

These data are used as read across data for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics.

Key value for chemical safety assessment

Additional information

The estimated aquatic invertebrate 48h EL50 (No Observed Effect Loading Rate) value for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) determined using the Petrotox computer model (CONCAWE, 2010) is >1000 mg/L with Daphnia magna, based on mobility.

Water accommodated fractions of hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics, produced a 48-hour EL50 value in the range 10 - 22 mg/L with Daphnia magna.

 

Water accommodated fractions of hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, 2-25% aromatics, produced a 48-hour EL50 value in the range 100 - 220 mg/L with Daphnia magna.

 

Water accommodated fractions of hydrocarbons, C16 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause acute toxicity to the freshwater invertebrate, Daphnia magna at a nominal loading of 1000 mg/L.

 

These data are used as read across data for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics.