Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14-04-2021 to 30-04-2021
- 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)
- Version / remarks:
- adopted 21 July 1997, corrected 26 June 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Petroleum diesel/gas oil fraction, co-processed with renewable hydrocarbons derived from thermally cracked plastics
- IUPAC Name:
- Petroleum diesel/gas oil fraction, co-processed with renewable hydrocarbons derived from thermally cracked plastics
- Test material form:
- liquid
- Details on test material:
- OMV sample
Name: OMV Gas Oil Co-pro with terminally cracked plastics
Batch: 2021/007709, 16-Feb-21, CoRPC 1-21
Report: 2021-SUNB-001022 (UOP990)
Report date: 13-Aug-21
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
- Test concentrations with justification for top dose:
- Test 1: 50, 16, 5, 1.6, 0.5, 0.16, 0.05, 0.016 mg/mL
Test 2: 100, 32, 10, 3.2, 1, 0.32, 0.1, 0.032 mg/mL
The top dose was selected based on current OECD guidelines and findings from the preliminary assessment of solubility. - 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 Diesel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC 941-803-4), 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 two hours of formulation. - Evaluation criteria:
- 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.
- There was 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.
If any results had only partially satisfied the above criteria, they would be dealt with on a case-by case basis and biological relevance taken into account, for example, consistency of response within and between concentrations
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: evidence of cytotoxicity seen at 5000 μg/plate with and without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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: evidence of cytotoxicity seen at 5000 μg/plate with and without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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: evidence of cytotoxicity seen at 5000 μg/plate with and without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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: evidence of cytotoxicity seen at 5000 μg/plate with and without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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:
- other:
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Liquid pre-incubation test
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: evidence of cytotoxicity seen at 5000 μg/plate with metabolic activation; 1600 μg/plate without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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:
- other: evidence of cytotoxicity seen at 5000 μg/plate with metabolic activation; 1600 μg/plate without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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:
- other: evidence of cytotoxicity seen at 5000 μg/plate with metabolic activation; 1600 μg/plate without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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:
- other: evidence of cytotoxicity seen at 5000 μg/plate with metabolic activation; 1600 μg/plate without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without 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:
- other: evidence of cytotoxicity seen at 5000 μg/plate without metabolic activation
- Remarks:
- precipitate was seen at and above 1600 μg per plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mutagenic potential
Any other information on results incl. tables
Table 1 – Test 1: Petroleum Disel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC# 941-803-4): 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 |
1.5 |
10 |
0.6 |
33 |
1.7 |
144 |
11.0 |
196 |
3.2 |
1.6 |
13 |
2.3 |
8 |
1.5 |
31 |
1.2 |
143 |
17.1 |
195 |
16.2 |
5 |
11 |
1.5 |
9 |
0.6 |
30 |
3.5 |
153 |
9.3 |
205 |
3.2 |
16 |
13 |
1.5 |
11 |
3.0 |
33 |
3.8 |
139 |
15.6 |
204 |
4.0 |
50 |
12 |
0.0 |
11 |
1.5 |
32 |
2.6 |
131 |
11.0 |
208 |
3.5 |
160 |
12 |
0.6 |
10 |
2.1 |
36 |
3.0 |
144 |
7.1 |
190 |
4.2 |
500 |
11 |
1.2 |
10 |
0.6 |
39 |
1.7 |
134 |
6.1 |
183 |
4.6 |
1600 |
11 |
1.2 |
11 |
0.6 |
32 |
1.7 |
146 |
15.9 |
195 |
8.1 |
5000 |
10 |
1.5 |
12 |
1.5 |
38 |
3.8 |
152 |
12.0 |
194 |
3.6 |
Positive control |
162 |
6.8 |
148 |
26.1 |
1370 |
312.6 |
1772 |
336.5 |
1883 |
172.0 |
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 Disel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC# 941-803-4): 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 |
13 |
1.2 |
12 |
0.6 |
27 |
0.6 |
122 |
6.8 |
171 |
6.4 |
1.6 |
12 |
1.0 |
11 |
1.5 |
26 |
1.2 |
113 |
4.6 |
169 |
1.5 |
5 |
13 |
1.0 |
11 |
0.0 |
31 |
3.1 |
119 |
4.2 |
164 |
9.5 |
16 |
12 |
1.5 |
10 |
1.0 |
28 |
2.1 |
114 |
3.5 |
160 |
20.4 |
50 |
13 |
1.0 |
11 |
0.6 |
28 |
2.6 |
118 |
4.0 |
165 |
6.1 |
160 |
12 |
0.6 |
10 |
1.0 |
24 |
2.0 |
123 |
6.2 |
154 |
6.0 |
500 |
12 |
2.0 |
11 |
1.5 |
31 |
0.6 |
119 |
4.4 |
155 |
12.1 |
1600 |
13 |
0.6 |
9 |
1.2 |
27 |
4.4 |
119 |
9.9 |
147 |
3.1 |
5000 |
10 |
2.5 |
6 |
1.7 |
27 |
3.8 |
110 |
6.6 |
147 |
6.1 |
Positive control |
427 |
26.4 |
216 |
25.2 |
234 |
62.4 |
472 |
8.5 |
988 |
46.8 |
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 Disel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC# 941-803-4): 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 |
11 |
1.7 |
12 |
1.5 |
36 |
4.5 |
134 |
5.3 |
197 |
8.3 |
1.6 |
14 |
1.5 |
10 |
1.7 |
32 |
6.7 |
146 |
7.0 |
200 |
17.0 |
5 |
13 |
1.2 |
10 |
1.0 |
31 |
6.4 |
148 |
8.5 |
202 |
15.4 |
16 |
11 |
1.2 |
11 |
1.2 |
33 |
6.1 |
148 |
6.1 |
191 |
14.2 |
50 |
9 |
2.1 |
11 |
1.2 |
33 |
2.3 |
133 |
10.8 |
208 |
9.0 |
160 |
10 |
0.6 |
10 |
0.6 |
31 |
10.4 |
130 |
2.5 |
192 |
14.7 |
500 |
10 |
1.0 |
12 |
1.5 |
41 |
1.7 |
150 |
9.3 |
194 |
20.1 |
1600 |
11 |
2.1 |
10 |
1.5 |
34 |
4.2 |
145 |
24.2 |
190 |
18.6 |
5000 |
9 |
0.6 |
11 |
1.2 |
39 |
2.6 |
119 |
4.4 |
165 |
15.5 |
Positive control |
189 |
9.5 |
205 |
18.8 |
2149 |
163.2 |
3093 |
20.6 |
1947 |
81.8 |
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 Disel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC# 941-803-4): 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 |
10 |
0.0 |
31 |
2.6 |
119 |
2.1 |
159 |
9.0 |
1.6 |
12 |
1.2 |
9 |
1.2 |
31 |
1.2 |
110 |
5.2 |
148 |
10.1 |
5 |
12 |
1.0 |
9 |
0.6 |
29 |
4.6 |
117 |
2.6 |
169 |
6.5 |
16 |
12 |
0.6 |
10 |
2.1 |
28 |
5.1 |
116 |
3.8 |
162 |
15.7 |
50 |
13 |
1.2 |
8 |
1.5 |
30 |
4.5 |
115 |
3.1 |
147 |
14.4 |
160 |
11 |
1.2 |
10 |
0.6 |
26 |
3.2 |
111 |
0.6 |
146 |
8.2 |
5000 |
12 |
1.7 |
9 |
0.6 |
29 |
2.5 |
116 |
4.5 |
135 |
2.5 |
1600 |
12 |
1.5 |
6 |
0.6 |
26 |
3.6 |
112 |
4.0 |
132 |
7.4 |
5000 |
7 |
2.0 |
4 |
1.7 |
23 |
5.3 |
83 |
4.2 |
88 |
1.6 |
Positive control |
415 |
50.3 |
306 |
121.4 |
812 |
64.8 |
523 |
82.8 |
958 |
9.0 |
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 Diesel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC 941-803-4) 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 Diesel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC 941-803-4) 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 Diesel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC 941-803-4) 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, with 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 1600 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 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 Diesel/Gas Oil Fraction, Co-processed with Renewable Hydrocarbons Derived from Thermally Cracked Plastics (EC 941-803-4) 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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