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EC number: 931-254-9 | CAS number: 64742-49-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Due to migration, the value was transferred to one of the current document's attachments
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it is well documented and follows OECD Guideline 471.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Due to migration, the value was transferred to one of the current document's attachments
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it is well documented and follows OECD Guideline 471.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No positive responses were observed in any of the tester strains. The positive control substance, 2-aminoanthracene, did not produce any mutations in strain TA 1538 in one experiment in the presence of S9. As revertants were seen in the test of TA 1538 without S9, and revertants were seen in other strains exposed to positive controls with S9, the lack of revertants was most likely due to a technical error and the study is still considered valid.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative
The test substance is not mutagenic. - Executive summary:
This data is being read across from the source study that tested commercial hexane based on analogue read across.
This study examined the mutagenicity of vapors of the test substance commercial hexane. Plates of S. typhimurium were exposed for 7 -8 hrs to test atmospheres of 0, 600, 1000, 3000, 6000, or 9000 ppm of test substance. 20,000 ppm of 1,1 -dichloroethene was used a vapor-phase positive control substance. The test substance did not produce a positive response in any of the test strains. The test substance is not mutagenic.
Average Revertants per Plate (SD) - Experiment B1
Dose (ppm) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Without S9 |
|||||
0.0 |
17 ± 1 |
105 ± 12 |
11 ± 1 |
7 ± 1 |
8 |
600 |
20 ± 5 |
113 ± 9 |
13 ± 4 |
6 ± 1 |
6 |
1000 |
16 ± 3 |
121 ± 8 |
14 ± 2 |
7 ± 1 |
6 |
3000 |
18 ± 4 |
112 ± 13 |
17 ± 3 |
5 ± 4 |
4 |
6000 |
24 ± 4 |
117 ± 14 |
12 ± 4 |
6 ± 4 |
8 |
9000 |
17 ± 3 |
112 ± 7 |
14 ± 5 |
9 ± 2 |
5 |
Positive control |
227 ± 8 |
422 ± 44 |
349 ± 36 |
481 ± 135 |
452 |
With S9 |
|||||
0.0 |
24 ± 5 |
119 ± 10 |
17 ± 1 |
7 ± 0 |
12 |
600 |
30 ± 10 |
137 ± 12 |
23 ± 4 |
9 ± 4 |
15 |
1000 |
23 ± 5 |
126 ± 3 |
14 ± 2 |
11 ± 5 |
13 |
3000 |
22 ± 1 |
120 ± 19 |
16 ± 2 |
9 ± 2 |
9 |
6000 |
24 ± 2 |
103 ± 11 |
14 ± 4 |
7 ± 2 |
11 |
9000 |
30 ± 6 |
120 ± 3 |
17 ± 1 |
8 ± 2 |
14 |
Positive control |
3142 ± 139 |
3902 ± 68 |
189± 22 |
351 ± 26 |
-- |
Positive vapor control |
372 ± 52 |
Average Revertants per Plate (SD) - Experiment B2
Dose (ppm) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Without S9 |
|||||
0.0 |
12 ± 2 |
107 ± 11 |
9 ± 5 |
5 ± 1 |
19 |
600 |
20 ± 1 |
103 ± 9 |
8 ± 4 |
7 ± 3 |
19 |
1000 |
14 ± 4 |
110 ± 6 |
12 ± 5 |
7 ± 2 |
19 |
3000 |
14 ± 1 |
124 ± 14 |
12 ± 2 |
7 ± 2 |
19 |
6000 |
22 ± 6 |
125 ± 14 |
15 ± 1 |
5 ± 2 |
16 |
9000 |
15 ± 6 |
114 ± 5 |
13 ± 3 |
5 ± 3 |
13 |
Positive control |
444 ± 86 |
991 ± 67 |
758 ± 19 |
162 ± 51 |
754 |
With S9 |
|||||
0.0 |
21 ± 4 |
132 ± 16 |
17 ± 4 |
7 ± 3 |
26 |
600 |
25 ± 7 |
133 ± 8 |
18 ± 2 |
6 ± 1 |
25 |
1000 |
22 ± 2 |
155 ± 4 |
15 ± 7 |
8 ± 3 |
25 |
3000 |
20 ± 1 |
123 ± 23 |
16 ± 7 |
7 ± 3 |
24 |
6000 |
21 ± 4 |
151 ± 14 |
15 ± 1 |
6 ± 2 |
30 |
9000 |
25 ± 4 |
161 ± 8 |
11 ± 4 |
6 ± 1 |
27 |
Positive control |
2187 ± 166 |
2229 ± 223 |
166 ± 32 |
230 ± 24 |
2195 |
Positive vapor control |
394 ± 50 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The method was modified to use the dessicator methodology in order to test the mutagenicity of the vapor phase of the test substance.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- commercial hexane
- IUPAC Name:
- commercial hexane
- Details on test material:
- - Name of test material (as cited in study report): commercial hexane
- Physical state: clear, water white liquid
- Composition of test material, percentage of components: 52.19% n-hexane
- Storage condition of test material: room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from aroclor induced rat liver
- Test concentrations with justification for top dose:
- Migrated Data from field(s)
Field "Justification for deviation from the high dose level" (Path: ENDPOINT_STUDY_RECORD.GeneticToxicityVitro.MaterialsAndMethods.Method.JustificationForDeviationFromTheHighDoseLevel): 0, 600, 1000, 3000, 6000, 9000 ppm
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: no solvent used
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-nitrofluorene, sodium azide, 9-aminoacridine, 1,1-dichloroethene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Prepared plates were placed uncovered and inverted in 9l dessicators. An appropriate amount of test substance was placed in a glass petri dish was suspended at the bottom of the dessicator. A magnetic stirring bar was placed at the bottom of the dessicator, and served as a fan to ensure even distribution of the vapor.
DURATION
- Preincubation period: 48 hrs
- Exposure duration: 7-8 hrs at 37 degree C
- Expression time (cells in growth medium): There was an additional incubation time of 40 hrs after exposure.
NUMBER OF REPLICATIONS: 3
- Evaluation criteria:
- To be considered positive for mutation, at least a doubling of mean revertants per plate in at least one tester strain must be seen. This increase must be dose-related.
- Statistics:
- Mean number of revertant per plate and the standard deviation was calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No positive responses were observed in any of the tester strains. The positive control substance, 2-aminoanthracene, did not produce any mutations in strain TA 1538 in one experiment in the presence of S9. As revertants were seen in the test of TA 1538 without S9, and revertants were seen in other strains exposed to positive controls with S9, the lack of revertants was most likely due to a technical error and the study is still considered valid.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Average Revertants per Plate (SD) - Experiment B1
Dose (ppm) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Without S9 |
|||||
0.0 |
17 ± 1 |
105 ± 12 |
11 ± 1 |
7 ± 1 |
8 |
600 |
20 ± 5 |
113 ± 9 |
13 ± 4 |
6 ± 1 |
6 |
1000 |
16 ± 3 |
121 ± 8 |
14 ± 2 |
7 ± 1 |
6 |
3000 |
18 ± 4 |
112 ± 13 |
17 ± 3 |
5 ± 4 |
4 |
6000 |
24 ± 4 |
117 ± 14 |
12 ± 4 |
6 ± 4 |
8 |
9000 |
17 ± 3 |
112 ± 7 |
14 ± 5 |
9 ± 2 |
5 |
Positive control |
227 ± 8 |
422 ± 44 |
349 ± 36 |
481 ± 135 |
452 |
With S9 |
|||||
0.0 |
24 ± 5 |
119 ± 10 |
17 ± 1 |
7 ± 0 |
12 |
600 |
30 ± 10 |
137 ± 12 |
23 ± 4 |
9 ± 4 |
15 |
1000 |
23 ± 5 |
126 ± 3 |
14 ± 2 |
11 ± 5 |
13 |
3000 |
22 ± 1 |
120 ± 19 |
16 ± 2 |
9 ± 2 |
9 |
6000 |
24 ± 2 |
103 ± 11 |
14 ± 4 |
7 ± 2 |
11 |
9000 |
30 ± 6 |
120 ± 3 |
17 ± 1 |
8 ± 2 |
14 |
Positive control |
3142 ± 139 |
3902 ± 68 |
189± 22 |
351 ± 26 |
-- |
Positive vapor control |
372 ± 52 |
Average Revertants per Plate (SD) - Experiment B2
Dose (ppm) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Without S9 |
|||||
0.0 |
12 ± 2 |
107 ± 11 |
9 ± 5 |
5 ± 1 |
19 |
600 |
20 ± 1 |
103 ± 9 |
8 ± 4 |
7 ± 3 |
19 |
1000 |
14 ± 4 |
110 ± 6 |
12 ± 5 |
7 ± 2 |
19 |
3000 |
14 ± 1 |
124 ± 14 |
12 ± 2 |
7 ± 2 |
19 |
6000 |
22 ± 6 |
125 ± 14 |
15 ± 1 |
5 ± 2 |
16 |
9000 |
15 ± 6 |
114 ± 5 |
13 ± 3 |
5 ± 3 |
13 |
Positive control |
444 ± 86 |
991 ± 67 |
758 ± 19 |
162 ± 51 |
754 |
With S9 |
|||||
0.0 |
21 ± 4 |
132 ± 16 |
17 ± 4 |
7 ± 3 |
26 |
600 |
25 ± 7 |
133 ± 8 |
18 ± 2 |
6 ± 1 |
25 |
1000 |
22 ± 2 |
155 ± 4 |
15 ± 7 |
8 ± 3 |
25 |
3000 |
20 ± 1 |
123 ± 23 |
16 ± 7 |
7 ± 3 |
24 |
6000 |
21 ± 4 |
151 ± 14 |
15 ± 1 |
6 ± 2 |
30 |
9000 |
25 ± 4 |
161 ± 8 |
11 ± 4 |
6 ± 1 |
27 |
Positive control |
2187 ± 166 |
2229 ± 223 |
166 ± 32 |
230 ± 24 |
2195 |
Positive vapor control |
394 ± 50 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test substance is not mutagenic. - Executive summary:
This study examined the mutagenicity of vapors of the test substance commercial hexane. Plates of S. typhimurium were exposed for 7 -8 hrs to test atmospheres of 0, 600, 1000, 3000, 6000, or 9000 ppm of test substance. 20,000 ppm of 1,1 -dichloroethene was used a vapor-phase positive control substance. The test substance did not produce a positive response in any of the test strains. The test substance is not mutagenic.
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