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EC number: 941-364-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-Nov-2020 to 20-Nov-2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin
- EC Number:
- 941-364-9
- Molecular formula:
- Not applicable to UVCB substance
- IUPAC Name:
- Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin
- Test material form:
- other: Low visocosity, liquid hydrocarbon
- Details on test material:
- Batch number: 204377961
Physical description: Colourless or pale yellow coloured liquid
Purity: 100% UVCB
Expiry date: 20 August 2022 if kept under storge conditions
Source and site of characterisation: Repsol Refinery, Carretera de la Calzada s/n, Apartado de Correos 12, 13500 Puertollano, Ciudad Real, Spain
Storage conditions: Store under controlled humidity conditions and temperature (18-25 °C) in a sealed container, protecting the product from sunlight (opaque container or in a cabinet)
Constituent 1
Method
- Target gene:
- S. typhimurium strains: his-operon
E. coli strains: tryptophan-operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene, Potassium dichromate
- Details on test system and experimental conditions:
- Preliminary assessment of solubility
A preliminary solubility assessment was conducted for the test item, Petroleum Gas Oil Fraction, Co-processed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9), at 100 mg per mL in dimethyl sulphoxide (DMSO). As the test item dissolved in DMSO at 100 mg per mL, solubility was not assessed with any other solvents and DMSO was used as the solvent for the test item throughout this study.
Mutagenicity tests
Test 1
A plate incorporation mutagenicity test was performed using Salmonella typhimurium LT2 strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2 strain uvrA/pKM101, in both the presence and absence of S9 mix. In all cases there were three plates in the solvent control, test item and positive control groups.
Test 2
For Test 2, a liquid pre-incubation test was performed using Salmonella typhimurium LT2 strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2 strain uvrA/pKM101 in the presence and absence of S9 mix. In all cases there were three plates in the solvent control, test item and positive control groups.
Test item administration
The test item was administered in solvent (DMSO) at a volume of 100 μL per plate for the plate incorporation method and a volume of 50 μL per plate when the liquid pre-incubation method was employed, within a maximum of three hours of formulation. - Evaluation criteria:
- Test acceptance criteria
A minimum of five analysable (scoreable) concentrations was required, with at least four showing no signs of cytotoxicity.
Evaluation
Cytotoxicity
A dose of the test item was judged to be toxic to a bacterial strain if the formation of microcolonies (background lawn) was reduced, or a relevant decrease in the number of revertant colonies was seen.
Mutagenicity
A test item was considered to be mutagenic if the following criteria were satisfied:
- For all five strains, the mean number of revertant colonies is equal to or greater than 2 times the concurrent solvent control mean value at one or more doses of the test item, with or without. In addition, for TA1535 and TA1537, the mean number of revertant colonies of one or more doses of the test item, with or without metabolic activation must be equal to or greater than 2 times the relevant historical mean value.
- There was a dose-related increase in the number of revertant colonies.
- A reproducible (at one or more doses) increase in numbers of revertant colonies per plate in at least one strain with or without metabolic activation. - Statistics:
- The mean number of revertant colonies and standard deviations were calculated for all groups.
All valid data were plotted and analysed using a linear regression analysis programme.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Plate incorporation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: above 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Plate incorporation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: above 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Plate incorporation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: above 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Plate incorporation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: above 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- Plate incorporation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- above 500 μg/plate without metabolic activation; 1600 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- above 500 μg/plate without metabolic activation; 1600 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- above 500 μg/plate without metabolic activation; 1600 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- above 500 μg/plate without metabolic activation; 1600 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Plate incorporation test
On the day of dosing, precipitate was seen at and above 500 μg per plate for all five strains in both the presence and absence of S9 mix. On the day of scoring, precipitate was seen at and above 1600 μg per plate for all five strains in both the presence and absence of S9 mix.
Evidence of cytotoxicity as indicated by reductions in the growth of the background lawns or in the incidence of spontaneous revertant colonies was seen at a dose of 5000 μg per plate for the four S. typhimurium strains in the absence of S9 mix.
No significant increase in numbers of revertant (histidine or tryptophan-independent) colonies was seen with any of the five indicator strains either in the presence or absence of S9 mix.
Liquid pre-incubation test
On the day of dosing precipitate was seen at and above 500 μg per plate for all five strains in both the presence and absence of S9 mix. On the day of scoring, precipitate was seen at and above 1600 μg per plate for all five strains in both the presence and absence of S9 mix.
Evidence of cytotoxicity as indicated by reductions in the growth of the background lawns or in the incidence of spontaneous revertant colonies was seen at and above a dose of 500 μg per plate for the four S. typhimurium strains in the absence of S9 mix, at and above 1600 μg per plate for four S. typhimurium strains in the presence of S9 mix, and at 5000 μg per plate for the E. coli strain in the absence of S9 mix.
No significant increase in numbers of revertant (histidine or tryptophan-independent) colonies was seen with any of the five indicator strains either in the presence or absence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- no mutagenic potential
Any other information on results incl. tables
Table 1 – Test 1: Petroleum Gas Oil Fraction, Co-pressed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9): plate incorporation method – with metabolic activation
Dose per plate |
Number of revertant colonies per plate |
|||||||||
S. typhimuriumLT2 |
E. coliWP2 |
|||||||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
uvrA/pKM101 |
|||||
μg |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Solvent control |
12 |
2.1 |
11 |
1.5 |
37 |
2.5 |
138 |
10.0 |
201 |
7.8 |
1.6 |
14 |
2.1 |
13 |
1.2 |
34 |
4.5 |
154 |
5.0 |
202 |
14.6 |
5 |
12 |
2.0 |
12 |
0.6 |
33 |
3.2 |
142 |
11.4 |
201 |
12.4 |
16 |
10 |
1.0 |
13 |
1.5 |
36 |
2.1 |
131 |
7.8 |
214 |
1.5 |
50 |
13 |
2.1 |
11 |
1.5 |
31 |
6.1 |
120 |
11.2 |
187 |
9.5 |
160 |
12 |
2.0 |
12 |
2.1 |
34 |
7.6 |
147 |
6.2 |
191 |
17.9 |
500 |
11 |
3.1 |
9 |
1.2 |
38 |
3.1 |
142 |
18.5 |
192 |
14.7 |
1600 |
11 |
4.7 |
10 |
3.2 |
39 |
2.6 |
150 |
11.4 |
194 |
14.0 |
5000 |
11 |
4.9 |
15 |
1.5 |
40 |
11.4 |
152 |
3.8 |
178 |
17.6 |
Positive control |
176 |
7.5 |
152 |
4.5 |
1586 |
180.4 |
2455 |
20.9 |
1945 |
21.4 |
Positive controls
TA1535: 2-aminoanthracene 2 μg/plate
TA1537: 2-aminoanthracene 2 μg/plate
TA98: 2-aminoanthracene 2 μg/plate
TA100: 2-aminoanthracene 2 μg/plate
uvrA/pKM101: 2-aminoanthracene 20 μg/plate
Table 2 – Test 1: Petroleum Gas Oil Fraction, Co-pressed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9): plate incorporation method – without metabolic activation
Dose per plate |
Number of revertant colonies per plate |
|||||||||
S. typhimuriumLT2 |
E. coliWP2 |
|||||||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
uvrA/pKM101 |
|||||
μg |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Solvent control |
15 |
1.5 |
11 |
0.6 |
27 |
0.6 |
128 |
2.0 |
170 |
4.2 |
1.6 |
14 |
2.1 |
11 |
2.0 |
28 |
2.0 |
122 |
2.6 |
156 |
10.0 |
5 |
13 |
2.0 |
9 |
3.2 |
25 |
5.6 |
113 |
10.6 |
165 |
2.0 |
16 |
14 |
1.5 |
10 |
0.6 |
24 |
7.1 |
104 |
2.5 |
173 |
3.0 |
50 |
11 |
1.7 |
9 |
3.8 |
23 |
6.1 |
110 |
3.2 |
155 |
4.2 |
160 |
12 |
1.2 |
11 |
1.5 |
23 |
7.0 |
110 |
9.7 |
150 |
13.9 |
500 |
14 |
2.6 |
12 |
1.7 |
26 |
4.5 |
113 |
12.8 |
141 |
8.3 |
1600 |
11 |
0.6 |
10 |
2.5 |
25 |
5.5 |
101 |
10.8 |
141 |
10.0 |
5000 |
10 |
2.0 |
9 |
1.5 |
24 |
2.1 |
100 |
8.2 |
145 |
5.7 |
Positive control |
432 |
7.6 |
195 |
8.3 |
360 |
13.1 |
558 |
28.3 |
1000 |
57.3 |
Positive controls
TA1535: sodium azide 0.5 μg/plate
TA1537: 2-aminocridine.HCl 50 μg/plate
TA98: 2-nitrofluorene 1 μg/plate
TA100: sodium azide 0.5 μg/plate
uvrA/pKM101: potassium dichromate 25 μg/plate
Table 3 – Test 2: Petroleum Gas Oil Fraction, Co-pressed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9): liquid pre-incubation method – with metabolic activation
Dose per plate |
Number of revertant colonies per plate |
|||||||||
S. typhimuriumLT2 |
E. coliWP2 |
|||||||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
uvrA/pKM101 |
|||||
μg |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Solvent control |
10 |
0.6 |
9 |
1.0 |
32 |
3.1 |
142 |
6.7 |
209 |
6.7 |
1.6 |
11 |
1.0 |
10 |
2.1 |
31 |
2.6 |
148 |
5.0 |
193 |
7.6 |
5 |
12 |
1.0 |
8 |
2.6 |
18 |
8.1 |
140 |
16.6 |
197 |
23.5 |
16 |
10 |
0.6 |
8 |
2.0 |
29 |
6.6 |
115 |
19.3 |
197 |
8.6 |
50 |
10 |
3.1 |
8 |
2.0 |
30 |
6.0 |
120 |
9.2 |
208 |
1.5 |
160 |
9 |
3.1 |
9 |
3.5 |
24 |
2.1 |
113 |
28.7 |
192 |
7.0 |
500 |
10 |
2.1 |
9 |
3.2 |
25 |
5.5 |
125 |
2.1 |
204 |
13.2 |
1600 |
7 |
2.0 |
6 |
2.1 |
25 |
5.6 |
116 |
11.8 |
195 |
12.7 |
5000 |
8 |
1.5 |
8 |
1.5 |
25 |
1.0 |
111 |
11.0 |
175 |
8.5 |
Positive control |
126 |
1.5 |
102 |
6.1 |
1327 |
105.1 |
1769 |
35.4 |
1844 |
56.7 |
Positive controls
TA1535: 2-aminoanthracene 2 μg/plate
TA1537: 2-aminoanthracene 2 μg/plate
TA98: 2-aminoanthracene 2 μg/plate
TA100: 2-aminoanthracene 2 μg/plate
uvrA/pKM101: 2-aminoanthracene 20 μg/plate
Table 4 – Test 2: Petroleum Gas Oil Fraction, Co-pressed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9): liquid pre-incorporation method – without metabolic activation
Dose per plate |
Number of revertant colonies per plate |
|||||||||
S. typhimuriumLT2 |
E. coliWP2 |
|||||||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
uvrA/pKM101 |
|||||
μg |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Solvent control |
13 |
1.2 |
9 |
0.6 |
28 |
1.2 |
118 |
2.5 |
146 |
7.2 |
1.6 |
12 |
1.0 |
9 |
0.6 |
27 |
5.7 |
120 |
4.2 |
148 |
7.1 |
5 |
12 |
2.0 |
8 |
1.0 |
26 |
1.7 |
113 |
3.5 |
135 |
2.0 |
16 |
11 |
2.6 |
9 |
2.1 |
28 |
2.1 |
116 |
6.8 |
143 |
5.0 |
50 |
10 |
1.5 |
11 |
1.2 |
27 |
4.5 |
110 |
3.6 |
132 |
6.8 |
160 |
11 |
2.1 |
8 |
1.2 |
23 |
6.0 |
101 |
3.0 |
128 |
6.0 |
500 |
10 |
2.6 |
5 |
3.1 |
16 |
1.5 |
98 |
8.9 |
121 |
7.8 |
1600 |
5 |
1.2 |
4 |
0.6 |
17 |
3.1 |
76 |
14.5 |
122 |
17.4 |
5000 |
7 |
1.0 |
3 |
1.5 |
15 |
3.0 |
100 |
7.8 |
100 |
4.0 |
Positive control |
435 |
22.0 |
175 |
15.0 |
343 |
27.4 |
444 |
28.0 |
939 |
29.7 |
Positive controls
TA1535: sodium azide 0.5 μg/plate
TA1537: 2-aminocridine.HCl 50 μg/plate
TA98: 2-nitrofluorene 1 μg/plate
TA100: sodium azide 0.5 μg/plate
uvrA/pKM101: potassium dichromate 25 μg/plate
Applicant's summary and conclusion
- Conclusions:
- It was concluded that Petroleum Gas Oil Fraction, Co-processed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9) was not mutagenic for Salmonella typhimurium LT2 strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2 strain uvrA/pKM101, either in the presence or absence of S9 mix, when tested under the conditions used in this assay.
- Executive summary:
Petroleum Gas Oil Fraction, Co-processed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9) was tested for mutagenic activity using genetically modified Salmonella typhimurium LT2 bacteria of strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2 strain uvrA/pKM101 as indicator organisms, according to the methods of Maron and Ames, 1983, Venitt et al, 1984, Mortelmans and Zeiger, 2000 and Mortelmans and Riccio, 2000.
A preliminary solubility test was conducted. Dimethyl sulphoxide was found to be suitable and was therefore used throughout this study as the solvent for the test item.
A mutagenicity test was conducted for Petroleum Gas Oil Fraction, Co-processed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9) using the plate incorporation method (Test 1) for all five indicator strains in both the presence and absence of an in vitro activation system based on S9 fraction obtained from Aroclor 1254-induced rat liver (S9 mix). The dose range used was 1.6 to 5000 μg per plate. As the result of Test 1 was clearly negative, a confirmatory test was carried out using the liquid pre-incubation method, Test 2, using a dose range of 1.6 to 5000 μg per plate in the presence and absence of S9 mix.
The test item showed evidence of cytotoxicity. The minimum dose level at which cytotoxicity was seen was 500 μg per plate. The maximum dose level scored for revertant colonies was 5000 μg per plate. The minimum dose level at which precipitate was seen on the test plates was 1600 μg per plate.
No significant increase in numbers of revertant (histidine or tryptophan-independent) colonies was seen with any of the five indicator strains either in the presence or absence of S9 mix.
It was concluded that Petroleum Gas Oil Fraction, Co-processed with Renewable Hydrocarbons of Plant and/or Animal Origin (EC 941-364-9) was not mutagenic for Salmonella typhimurium LT2 strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2 strain uvrA/pKM101, either in the presence or absence of S9 mix, when tested under the conditions used in this assay.
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