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EC number: 203-915-5 | CAS number: 111-85-3
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-chlorooctane
- EC Number:
- 203-915-5
- EC Name:
- 1-chlorooctane
- Cas Number:
- 111-85-3
- Molecular formula:
- C8H17Cl
- IUPAC Name:
- 1-chlorooctane
Constituent 1
Method
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- 1st experiment: 5000, 1667, 556, 185 and 62 µg/plate and 0 µg/plate (control)
2nd experiment: 100, 25, 5, 1, 0.2 µg/plate and 0 µg/plate (control)
3rd experiment: 5, 2.5, 1.25, 0.63 and 0.3 µg/plate and 0 µg/plate (control) - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98
Migrated to IUCLID6: 4 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA 1535
Migrated to IUCLID6: 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2 uvrA
Migrated to IUCLID6: 1 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537
Migrated to IUCLID6: 50 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2 -10 µg/plate 2-Aminoanthracene
- Remarks:
- all tester strains excetp TA98 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA98 with metabolic activation
Migrated to IUCLID6: 30 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72h
-Titers of overnight cultures: > 10^8
- Selection time (if incubation with a selection agent): 72h
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS:triplicates, two assays
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth with strains TA98 and TA100
- Evaluation criteria:
- - negative control in the laboratory historical range for each tester strain
- positive control chemicals produce responses in all tester strains within laboratory historical range
- Mean plate count should be at least two times the concurrent vehicle control group mean in both assays and in a dose dependent response
- selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate
- To ensure that appropriate numbers of bacteria are plated, overnight culture titers must be in excess of 10^8 bacteria/ml - Statistics:
- not applicable
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
COMPARISON WITH HISTORICAL CONTROL DATA: all control data are in the range of the historical control data
ADDITIONAL INFORMATION ON CYTOTOXICITY: see table below - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
| TA1535 | TA1537 | TA98 | TA100 | TA102 | ||||||
| Assay 1 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 |
| 62 | 0.4 | 0.5 | 0.5 | 0.8 | 0.5 | 0.6 | 0.3 | 0.5 | 0.2 | 0.5 |
| 185 | 0.3 | 0.4 | 0.1 | 0.6 | 0.1 | 0.5 | 0.2 | 0.4 | ||
| 556 | T | 0.4 | T | T | 0.4 | 0.8 | T | 0.5 | 0.2 | 0.3 |
| 1667 | T | T | T | T | 0.1 | 0.5 | T | 0.4 | 0 | 0.3 |
| 5000 | T | T | T | T | T | T | T | T | T | 0.3 |
| Assay 2 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 |
| 0.2 | 0.5 | 1.8 | 1 | 1 | 1.1 | 0.9 | 1.1 | 1.1 | 1 | 0.8 |
| 1 | 1.2 | 1.1 | 1.3 | 1 | 1.4 | 0.9 | 1.2 | 1.2 | 1 | 1 |
| 5 | 0.9 | 1 | 1.3 | 1 | 0.6 | 1.2 | 0.9 | 1 | 1 | 0.9 |
| 25 | 0.3 | 1 | 0.7 | 0.8 | 0.5 | 1 | 0.4 | 0.6 | 0.5 | 0.6 |
| 100 | 0.4 | 0.4 | 0.3 | 1 | 0.2 | 0.6 | 0.3 | 0.5 | 0.2 | 0.4 |
| Assay 3 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 | wo S9 | w S9 |
| 0.3 | 1.2 | 0.7 | 0.8 | 1.3 | 1.1 | 0.7 | 1.1 | 0.8 | 0.9 | 1.1 |
| 0.63 | 1.2 | 0.8 | 0.6 | 1.3 | 1.3 | 0.9 | 1 | 1.1 | 0.9 | 1.1 |
| 1.25 | 0.8 | 0.8 | 0.8 | 1 | 1.1 | 0.9 | 0.9 | 0.9 | 1.2 | 0.9 |
| 2.5 | 1 | 0.8 | 0.4 | 2 | 0.8 | 1 | 1.1 | 1 | 1 | 1 |
| 5 | 0.9 | 1 | 0.6 | 2 | 1 | 0.8 | 0.8 | 1 | 0.9 | 1.2 |
wo S9: without metabolic activation
w S9: with metabolic activation
T: Toxicity, no background
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The test substance induced no mutagenic effect in S. typhimurium and E. coli WP 2 uvrA tester strains used in the test. High cytotoxicity was observed resulting in a reduced background growth in concentration > 5 µg/plate.
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