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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Ecotoxicological information

Long-term toxicity to fish

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Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene conc.
- Name of the substance for which the testing proposal will be used [if different from tested substance]: same as above

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: none
- Available non-GLP studies: none
- Historical human data: not applicable
- (Q)SAR: Petrotox model is available. The results of the fish experimental testing will be used to support the applicability of the PetroTox model to LOA substances
- In vitro methods: not applicable
- Weight of evidence: none available
- Grouping and read-across: a read-across approach is applied to this UVCB category, and this study will support this strategy.
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable
- Other reasons [if applicable]: not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The specific adaptation possibilities of Annexes VI to X (and Column 2 thereof) are not applicable in this case.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: OECD 210 Test Method (Fish, Early-life Stage Toxicity Test) and Guidance Document On Aqueous-Phase Aquatic Toxicity Testing Of Difficult Test Chemicals, Series On Testing And Assessment No. 23 (Second Edition)
Reason / purpose for cross-reference:
assessment report
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 7 2.49
8 4.24
9 66.33
10 5.12
Naphthenic Mono-Aromatic (NMAr) 9 19.58
Total 97.76

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.779 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.779 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for` O. mykiss was 0.779 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 6 0.44
7 2.99
8 5.10
9 83.11
10 0.95
Naphthenic Mono-Aromatic (NMAr) 9 2.40
Di-Aromatic (DiAr) 10 1.13
n-Olefin 10 0.54
n-Paraffin (n-P) 10 0.14
11 0.33
Total 97.12

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.73 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.73 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.73 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 7 1.55
8 31.91
9 17.86
10 2.89
12 2.29
13 0.67
Di-Aromatic (DiAr) 10 1.03
13 0.28
14 0.24
15 0.28
n-Olefin 5 0.27
10 21.06
11 0.41
i-Olefin 9 0.30
Total 81.03

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.199 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length, weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.199mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.199mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 6 0.57
7 0.19
9 0.50
12 0.98
13 0.31
Di-Aromatic (DiAr) 10 0.27
n-Olefin 5 0.63
10 62.38
11 23.68
Total 89.52

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.125 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.125 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.125 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 7 0.75
8 35.64
9 17.80
10 2.99
12 0.35
13 0.23
Di-Aromatic (DiAr) 10 0.22
n-Cyclohexane (n-CC6) 7 0.11
iso-Naphthenic (i-N) 8 0.10
n-Olefin 5 0.58
6 0.17
9 0.61
10 23.76
i-Olefin 6 0.21
n-Paraffin (n-P) 7 0.12
8 0.18
9 0.30
Total 84.13

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.282 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.282 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.282 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
n-olefin 5 0.57
9 1.24
10 76.50
11 14.84
12 1.21
Total 94.37

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.126 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.126 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.126 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See Attached Justification
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6
Principles of method if other than guideline:
- Software tool(s) used including version:
See Field 'Attached justification'
- Model(s) used:
See Field 'Attached justification'
- Model description: See Field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
GLP compliance:
not specified
Specific details on test material used for the study:
HC Block Type Carbon Number Concentration (%w/w)
Mono-Aromatic (MoAr) 8 1.51
9 42.57
10 7.04
Naphthenic Mono-Aromatic (NMAr) 9 0.98
10 0.36
Di-Aromatic (DiAr) 10 8.24
11 0.85
n-Olefin 5 0.22
9 0.13
10 26.65
11 4.67
Total 93.21

The constituents that could fit in more than one HC block, or that did not fit in any specific block, were placed in a relevant block that presented the highest toxicity.
Analytical monitoring:
not required
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
other: QSAR
Total exposure duration:
60 d
Reference substance (positive control):
not required
Key result
Duration:
60 d
Dose descriptor:
EL10
Effect conc.:
0.256 mg/L
Nominal / measured:
estimated
Conc. based on:
other: QSAR prediction
Basis for effect:
other: hatch, survival
Remarks:
length and weight
Remarks on result:
other: QSAR predicted value
Validity criteria fulfilled:
yes
Conclusions:
The QSAR predicted 60-d EL10 (hatch, survival, length and weight) for O. mykiss was 0.256 mg/L.
Executive summary:

The QSAR predicted 60-d EL10 (hatch, survival, length and weight) of the UVCB substance for O. mykiss was 0.256 mg/L. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Description of key information

The aquatic toxicity was predicted by a QSAR, the PETROTOX v4.0 computer model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. The substances of this category fit within the criteria of the model and there are no reservations about the validity of the model runs. The predicted 60-d EL10 values ( hatch, survival, length and weight) for Oncorhynchus mykiss ranged from 0.125 to 0.779 mg/L.

 

A testing proposal for an OECD 210 test is being included in the dossier. This test is being proposed to generate experimental data for fish in order to show the validity of PETROTOX for fish toxicity in LOA streams.

Key value for chemical safety assessment

Additional information

The PETROTOX v4.0 model combines a partitioning model used to calculate the aqueous concentration of hydrocarbon constituents 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.

 

The predicted values were:

Species Substance CAS No. EL10 (mg/L)
Oncorhynchus mykiss 68516-20-1 0.282
Oncorhynchus mykiss 101316-62-5 0.779
Oncorhynchus mykiss 68526-56-7 0.126
Oncorhynchus mykiss 68477-54-3 0.199
Oncorhynchus mykiss 94733-07-0 0.256
Oncorhynchus mykiss 68478-10-4 0.125
Oncorhynchus mykiss 65996-79-4 0.730