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EC number: 272-812-5 | CAS number: 68915-39-9
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- BASF AG, Experimental Toxicology and Ecology
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cyclohexane, oxidized, aq. ext., sodium salt
- EC Number:
- 272-812-5
- EC Name:
- Cyclohexane, oxidized, aq. ext., sodium salt
- Cas Number:
- 68915-39-9
- Molecular formula:
- Unspecified (UVCB substance)
- IUPAC Name:
- Cyclohexane, oxidized, aq. ext., sodium salt
- Details on test material:
- - Name of test material (as cited in study report): Natriumcarboxylat-Loesung
- Physical state: Liquid, brown, clear
- Composition of test material, percentage of components: Aqueous solution (about 53.6% water)
- Lot/batch No.: Probe EX 1672
- Stability under test conditions: stable under storage conditions throughout the study period
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- his, trp
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:
- phenobarbital and β-naphthoflavone induced S9 mix
- Test concentrations with justification for top dose:
- Standard plate test (SPT) with and without S9 mix: 0, 44, 220, 1100, 5500 and 11000 μg/plate;
Preincubation test (PIT) with and without S9 mix: 0, 687.5, 1375, 2750, 5500 and 11000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in water, water was used as vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, dissolved in DMSO for all strains
- Remarks:
- with S9 mix
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N-nitro-N-nitrosoguanidine, 5 μg/plate, dissolved in DMSO for TA 1535, TA 100
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine, 10 μg/plate, dissolved in DMSO for TA 98
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix
Migrated to IUCLID6: 100 μg/plate, dissolved in DMSO for TA 1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
PROCEDURE
- The experimental procedure of the standard plate test (plate incorporation method) was based on the method of Ames et al. (Mut. Res., 31, 347 - 364, 1975)
- The experimental procedure of the Preincubation Test was based on the method described by Yahagi et al. (Mut. Res., 48, 121 - 130, 1977) and Matsushima et al (In: Norpoth, K.H. and R.C. Garner, Short-Term Test Systems for Detecting Carcinogens. Springer Verlag Berlin, Heidelberg, New York, 1980) - Evaluation criteria:
- - The test chemical is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies, i.e. about
doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
- A test substance is generally considered non-mutagenic in this test if the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
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:
- at 11000 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:
- at 11000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Standard Plate Test: Mean Revertants per plate
Dose (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0 |
30±5 |
30±2 |
98±4 |
99±8 |
14±1 |
14±2 |
9±2 |
9±3 |
38±6 |
43±3 |
44 |
29±4 |
27±1 |
102±8 |
103±28 |
16±2 |
18±2 |
10±3 |
8±2 |
39±5 |
38±5 |
220 |
27±7 |
24±9 |
96±7 |
96±5 |
12±2 |
14±3 |
8±2 |
8±2 |
40±3 |
45±3 |
1100 |
21±3 |
22±4 |
96±6 |
102±4 |
14±4 |
15±4 |
8±2 |
10±1 |
40±2 |
43±6 |
5500 |
26±5 |
24±4 |
112±18 |
107±13 |
14±3 |
15±1 |
7±0 |
8±2 |
38±6 |
47±5 |
11000 |
22±6 |
26±1 |
89±8 |
103±19 |
13±5 |
12±2 |
6±3 |
8±3 |
37±3 |
48±7 |
PC |
715±31 |
899±24 |
720±85 |
623±12 |
710±48 |
151±31 |
353±21 |
179±40 |
1093±49 |
212±51 |
Plate Incubation Test: Mean Revertants per plate
Dose (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0 |
25±4 |
33±5 |
92±18 |
92±1 |
10±2 |
13±4 |
7±2 |
7±2 |
36±1 |
44±3 |
687.5 |
21±4 |
32±6 |
88±4 |
101±2 |
14±4 |
14±2 |
9±2 |
5±1 |
45±10 |
38±5 |
1375 |
22±6 |
38±5 |
91±10 |
95±5 |
11±2 |
11±3 |
8±3 |
4±1 |
37±2 |
48±5 |
2750 |
19±3 |
33±7 |
93±8 |
95±15 |
14±2 |
9±3 |
9±1 |
6±3 |
39±3 |
51±3 |
5500 |
24±3 |
33±8 |
93±11 |
109±7 |
8±2 |
11±4 |
10±2 |
7±3 |
41±3 |
52±5 |
11000 |
17±5 |
2±7 |
107±3 |
76±2 |
10±4 |
9±2 |
9±3 |
5±1 |
39±5 |
46±4 |
PC |
627±19 |
546±44 |
803±32 |
522±35 |
1557±120 |
84±2 |
238±6 |
76±6 |
836±6 |
156±3 |
PC: positive control
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
