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Long-term toxicity to fish

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Endpoint:
long-term toxicity to fish, other
Remarks:
QSAR
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
October 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This summary has a reliability of 2 because the results are estimated using a computer model that is appropriate for use with this hydrocarbon substance.
Justification for type of information:
The aquatic toxicity was estimated by a QSAR, the Petrotox computer model (v 3.06). This model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partition coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The aquatic toxicity was estimated by a QSAR, the Petrotox computer model (v 3.06). This model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partition coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism
GLP compliance:
no
Remarks:
The data was calculated by a computer model
Analytical monitoring:
not required
Details on sampling:
No data
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
No data
Test type:
other: QSAR modelled data
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
No data
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
No data
Reference substance (positive control):
not required
Key result
Duration:
28 d
Dose descriptor:
NOELR
Effect conc.:
0.25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
No data
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
No data

The composition used to run the Petrotox model is below, derived from the boundary compositions in the SIP for the substance;

 Carbon Number  n-P i-P  i-N  MoAr
 10 1.593   1.593  1.593  0.098
 11 2.007 2.007 2.007  0.123
 12  3.388  3.388  3.388  3.388
 13  3.613  3.613  3.613  3.613
14   5.902  5.902  5.902 0.361
 15  4.426  4.426  4.426  0.271
 16  4.426  4.426  4.426  0.271
 17  2.715 2.715  2.715   0.166
 18  0.188  0.188  0.188  0.012
 19  0.188  0.188  0.188  0.012
 20  0.188  0.188  0.188  0.012
 21  0.188  0.188  0.188  0.012
 22  0.188  0.188  0.188  0.012
 23  0.188  0.188  0.188  0.012
 24  0.188  0.188  0.188  0.012
 25  0.188  0.188  0.188  0.012
 26  0.188  0.188  0.188  0.012
 27  0.188  0.188  0.188  0.012
 28  0.188  0.188  0.188  0.012
 29  0.188  0.188  0.188  0.012
 30  0.188  0.188  0.188  0.012
Validity criteria fulfilled:
yes
Conclusions:
The estimated freshwater fish 28-day NOELR (Loewst Observed Effect Loading Rate) value is 0.25 mg/L based on growth.
Executive summary:

The aquatic toxicity was estimated using the Petrotox computer model, which combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components as a function of substance loading with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism. The estimated freshwater fish 28-day NOELR (Lowest Observed Effect Loading Rate) value is 0.25 mg/L.

Endpoint:
fish, juvenile growth test
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
Not applicable, calculated value
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This summary has a reliability of 2 because the results are estimated using a computer model that is appropriate for use with this hydrocarbon substance.
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:
no guideline followed
Principles of method if other than guideline:
Tha aquatic toxicity was estimated by a QSAR, the Petrotox computer model. This model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partition coefficients (KMW) that describe the partitionning of the hydrocarbons between the water and organism.
GLP compliance:
no
Remarks:
The data were calculated by a computer model
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No test surrogate nor analogue material
Analytical monitoring:
not required
Details on sampling:
Not applicable (calculated data)
Vehicle:
no
Details on test solutions:
Not applicable (calculated data)
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Not applicable (calculated data)
Test type:
other: QSAR modeled data
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Post exposure observation period:
Not applicable (calculated data)
Hardness:
Not applicable (calculated data)
Test temperature:
Not applicable (calculated data)
pH:
Not applicable (calculated data)
Dissolved oxygen:
Not applicable (calculated data)
Salinity:
Not applicable (calculated data)
Nominal and measured concentrations:
Not applicable (calculated data)
Details on test conditions:
Not applicable (calculated data)
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOELR
Effect conc.:
0.13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
No details
Results with reference substance (positive control):
No reference substance
Reported statistics and error estimates:
Not applicable

No other information

Validity criteria fulfilled:
yes
Conclusions:
The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.13 mg/l based on growth.
Executive summary:

The aquatic toxicity was estimated using the Petrotox computer model, which combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components as a function of substance loading with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism.

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.13 mg/l based on growth.

 

Endpoint:
fish, juvenile growth test
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
Not applicable, calculated value
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This summary has a reliability of 2 because the results are estimated using a computer model that is appropriate for use with this hydrocarbon substance.
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:
no guideline followed
Principles of method if other than guideline:
Tha aquatic toxicity was estimated by a QSAR, the Petrotox computer model. This model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partition coefficients (KMW) that describe the partitionning of the hydrocarbons between the water and organism.
GLP compliance:
no
Remarks:
The data were calculated by a computer model
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
No test surrogate nor analogue material
Analytical monitoring:
not required
Details on sampling:
Not applicable (calculated data)
Vehicle:
no
Details on test solutions:
Not applicable (calculated data)
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Not applicable (calculated data)
Test type:
other: QSAR modeled data
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Post exposure observation period:
Not applicable (calculated data)
Hardness:
Not applicable (calculated data)
Test temperature:
Not applicable (calculated data)
pH:
Not applicable (calculated data)
Dissolved oxygen:
Not applicable (calculated data)
Salinity:
Not applicable (calculated data)
Nominal and measured concentrations:
Not applicable (calculated data)
Details on test conditions:
Not applicable (calculated data)
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOELR
Effect conc.:
0.091 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
No details
Results with reference substance (positive control):
No reference substance
Reported statistics and error estimates:
Not applicable

No other information

Validity criteria fulfilled:
yes
Conclusions:
The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.091 mg/l based on growth.
Executive summary:

The aquatic toxicity was estimated using the Petrotox computer model, which combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components as a function of substance loading with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism.

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.091 mg/l based on growth.

 

Endpoint:
fish, juvenile growth test
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
Not applicable, calculated value
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This summary has a reliability of 2 because the results are estimated using a computer model that is appropriate for use with this hydrocarbon substance.
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:
no guideline followed
Principles of method if other than guideline:
Tha aquatic toxicity was estimated by a QSAR, the Petrotox computer model. This model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partition coefficients (KMW) that describe the partitionning of the hydrocarbons between the water and organism.
GLP compliance:
no
Remarks:
The data were calculated by a computer model
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No test surrogate nor analogue material
Analytical monitoring:
not required
Details on sampling:
Not applicable (calculated data)
Vehicle:
no
Details on test solutions:
Not applicable (calculated data)
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Not applicable (calculated data)
Test type:
other: QSAR modeled data
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Post exposure observation period:
Not applicable (calculated data)
Hardness:
Not applicable (calculated data)
Test temperature:
Not applicable (calculated data)
pH:
Not applicable (calculated data)
Dissolved oxygen:
Not applicable (calculated data)
Salinity:
Not applicable (calculated data)
Nominal and measured concentrations:
Not applicable (calculated data)
Details on test conditions:
Not applicable (calculated data)
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOELR
Effect conc.:
0.079 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
No details
Results with reference substance (positive control):
No reference substance
Reported statistics and error estimates:
Not applicable

No other information

Validity criteria fulfilled:
yes
Conclusions:
The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.079 mg/l based on growth.
Executive summary:

The aquatic toxicity was estimated using the Petrotox computer model, which combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components as a function of substance loading with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism.

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value is 0.079 mg/l based on growth.

 

Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9-Oct-2001 to 30-Oct-2001
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 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
yes
Remarks:
Deviations did not impact the validity of the study.
Principles of method if other than guideline:
Study duration 21 days instead of 14 days as suggested by test guideline.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples were removed from the control and 2500 and 5000 mg/l concentrations on Day 0, 7, 14, and 21 of the study.
Vehicle:
no
Details on test solutions:
Test solutions were prepared as Water Accommodated Fractions (WAF). The test substance was added to test water, and stirred for 23 hours with a magnetic stirrer until equilibrium. The mixing was done at a slow enough speed as to not cause dispersion or emulsification of the undissolved test substance. The solution was allowed to stand for approximately 1 hour, to allow phase separation, before being carefully siphoned out via a glass tube (added prior to the addition of the test substance). Renewal of the test WAF was conducted every 24 hours.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Brachydanio rerio (Teleostei, Cyprinidae)
Source of supply - MPI Tubingen
Pre-treatment - the animals were held for >12 days, <5% mortality
(light/dark = 14h / 10h; illumination: GroLux fluorescent tubes).
The animals were 3.0 to 3.5 cm in size.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
20.7 to 23.7 dec C
pH:
8.3 to 8.5
Dissolved oxygen:
>75%
Salinity:
freshwater
Nominal and measured concentrations:
Nominal concentrations were: 0, 2500, 5000 mg/l.

Concentration analysis (TOC) of the control and 2500 and 5000 mg/l test concentrations gave results of <10 mg/l. Indicating very low solubility of the test substance.
Details on test conditions:
10 animals/conc.
20 L glass aquaria with aeration via glass pipette.
14h light / 10h dark.
Animals were fed 1 time per day
Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
LL50
Effect conc.:
> 5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Percent Mortality: (at end of test)
Control - 0%
2500 mg/l - 0%
5000 mg/l - 0%

Validity criteria fulfilled:
yes
Conclusions:
The chronic toxicity of Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) as measured by toxicity to the zebrafish (Brachydanio rerio) was evaluated in freshwater. Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) did not show toxic effects as a Water Accommodated Fraction (WAF) with a 21 -day LL50 of >5000 mg/l and is not chronically toxic to fish.
Executive summary:

The chronic toxicity of Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) as measured by toxicity to the zebrafish (Brachydanio rerio) was evaluated in freshwater. Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) did not show toxic effects as a Water Accommodated Fraction (WAF) with a 21 -day LL50 of >5000 mg/l and is not chronically toxic to fish.

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.

Petrotox has been run for the substance.

The estimated freshwater fish 28-day NOELR (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 0.25 mg/L with rainbow trout, Oncorhynchus mykiss, based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.13 mg/L based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.091 mg/L based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.079 mg/L based on growth.

 

Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause toxicity to fish in a 21-day toxicity study with Brachydanio rerio following standard test guidelines at a nominal loading of 5000 mg/L. These results indicate that hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics ( -30%) is not expected to be chronically toxic to fish.

 

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 aquatic toxicity was estimated using the Petrotox computer model (v. 3.04), which combines a partitioning model used to calculate the aqueous concentration of hydrocarbon components as a function of substance loading with the Target Lipid Model used to calculate acute and chronic toxicity of non-polar narcotic chemicals. Petrotox computes toxicity based on the summation of the aqueous-phase concentrations of hydrocarbon block(s) that represent a hydrocarbon substance and membrane-water partitioning coefficients (KMW) that describe the partitioning of the hydrocarbons between the water and organism.

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.25 mg/L based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.13 mg/L based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.091 mg/L based on growth.

 

The estimated freshwater fish 28-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 0.079 mg/L based on growth.

 

Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause toxicity to fish in a 21-day toxicity study with Brachydanio rerio following standard test guidelines at a nominal loading of 5000 mg/L. These results indicate that hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is not expected to be chronically toxic to fish.

 

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