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EC number: 279-632-6 | CAS number: 80939-62-4
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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:
- May 10, 1984 - July 16, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions: - E.coli was not included (to detect cross-linking mutagens) - positive controls were not conducted for each strain in the experiments with metabolic activation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (E.coli was not included (to detect cross-linking mutagens), positive controls were not conducted for each strain in the experiments with metabolic activation)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
- EC Number:
- 279-632-6
- EC Name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
- Cas Number:
- 80939-62-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 10 - 2560 µg/plate, range in the first and second mutagenicity test with and without microsomal activation
1 - 256 µg/plate, range in the third mutagenicity test without microsomal activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: TA 98: daunorubicin-HCl; TA 100: 4-nitroquinoline-N-oxide; TA 1535: N-methyl-N'-nitro-N-nitrosoguanidine/sodium azide; TA 1537: 9(5)aminoacridine hydrochloride monohydrate; +S9: TA 1535: cyclophosphamide, TA 100: aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: about 48 hours at 37 +/- 1.5 °C in darkness
NUMBER OF REPLICATIONS:
three plates per dose level
DETERMINATION OF CYTOTOXICITY
- Method: background growth - Evaluation criteria:
- When the colonies had been counted, the arithmetic mean was calculated. The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.
Results and discussion
Test results
- 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:
- (inhibiting effect as reduction in the colony count was observed at concentrations of 40 and 160 µg/0.1 ml without metabolic activation. This effect was more pronounced in the experiment without metabolic activation than in those with activation.)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 256 µg/0.1 ml and above the substance precipitated in soft agar.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the first and second experiment performed without microsomal activation treatment with the test substance revealed a reduction in the colony count in comparison with the controls due to a growthinhibiting effect of the compound at the concentrations of 40 and 160 µg/0.1 ml, respectively, and above. In the third experiment without microsomal activation a reduction in the colony count was observed at 64 µg/0.1 ml and above. In the experiments with activation this effect occurred at the concentrations of 640 µg/0.1 ml and above. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Number of back-mutant colonies per plate (mean and SD) of the first experiment in S. Typhimurium strains:
Dose (µg/0.1 ml) |
TA98 |
TA100 |
TA1535 |
TA1537 |
||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
26±5 |
34±6 |
134±13 |
144±16 |
17±2 |
16±3 |
9±5 |
14±6 |
10 |
26±1 |
37±17 |
128±22 |
131±20 |
15±0 |
15±9 |
9±3 |
13±6 |
40 |
22±4 |
33±7 |
100±12 |
151±11 |
8±1 |
14±1 |
5±4 |
7±2 |
160 |
19±8 |
45±8 |
31±4 |
134±15 |
4±2 |
14±5 |
11±4 |
14±3 |
640 |
16±8 |
40±3 |
6±3 |
51±14 |
11±5 |
7±1 |
1±2 |
10±10 |
2560 |
0±0 |
16±11 |
0±0 |
2±1 |
1±1 |
9±3 |
0±0 |
0±0 |
D-HCl (5) |
288±74 |
- |
- |
- |
- |
- |
- |
- |
D-HCl (10) |
677±83 |
- |
- |
- |
- |
- |
- |
- |
2-AA (5) |
- |
- |
- |
2016 ±288 |
- |
2016±288 |
- |
- |
MNNG (3) |
- |
- |
- |
- |
690±327 |
- |
- |
- |
MNNG (5) |
- |
- |
- |
- |
3204± (n.g.) |
- |
- |
- |
AAHC (50) |
|
|
|
|
|
|
84±36 |
|
AAHC (100) |
- |
- |
- |
- |
- |
- |
1772±176 |
- |
CP (250) |
- |
- |
- |
- |
- |
436±83 |
- |
- |
4-NQNO (0.125) |
- |
- |
1067±167 |
- |
- |
- |
- |
- |
4-NQNO (0.25) |
- |
- |
1773±199 |
- |
- |
- |
- |
- |
Table 2: Number of back-mutant colonies per plate (mean and SD) of the second experiment in S. typhimurium strains:
Dose (µg/0.1 ml) |
TA98 |
TA100 |
TA1535 |
TA1537 |
||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
21±11 |
39±2 |
120±7 |
108±8 |
8±4 |
6±2 |
8±3 |
13±3 |
10 |
26±9 |
32±7 |
109±17 |
120±5 |
11±3 |
12±4 |
5±2 |
11±4 |
40 |
24±3 |
43±6 |
84±16 |
120±14 |
9±5 |
12±3 |
6±1 |
12±6 |
160 |
7±1 |
38±13 |
39±16 |
103±11 |
5±5 |
9±3 |
4±3 |
11±3 |
640 |
2±1 |
42±1 |
16±7 |
68±11 |
11±7 |
13±1 |
1±2 |
12±10 |
2560 |
10±2 |
21±20 |
0±0 |
19±22 |
1±1 |
11±3 |
0±0 |
0±0 |
D-HCl (5) |
434±78 |
- |
- |
- |
- |
- |
- |
- |
D-HCl (10) |
957±30 |
- |
- |
- |
- |
- |
- |
- |
2-AA |
- |
- |
- |
- |
- |
- |
- |
- |
MNNG (3) |
- |
- |
- |
- |
- |
- |
- |
- |
MNNG (5) |
- |
- |
- |
- |
2014±425 |
- |
- |
- |
AAHC (50) |
- |
- |
- |
- |
- |
- |
65±42 |
- |
AAHC (100) |
- |
- |
- |
- |
- |
- |
1088±284 |
- |
CP (250) |
- |
- |
- |
- |
- |
428±19 |
- |
- |
4-NQNO (0.125) |
- |
- |
942±105 |
- |
- |
- |
- |
- |
4-NQNO (0.25) |
- |
- |
1504±42 |
- |
- |
- |
- |
- |
Table 3: Number of back-mutant colonies per plate (mean and SD) of the third experiment in S. typhimurium strains (performed only without metabolic activation):
Dose (µg/0.1 ml) |
TA98 |
TA100 |
TA1535 |
TA1537 |
||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
23±5 |
- |
128±7 |
- |
14±2 |
- |
9±1 |
- |
1 |
28±1 |
- |
131±13 |
- |
13±5 |
- |
10±3 |
- |
4 |
28±4 |
- |
124±4 |
- |
13±2 |
- |
7±4 |
- |
16 |
23±6 |
- |
121±17 |
- |
17±8 |
- |
9±5 |
- |
64 |
24±6 |
- |
83±8 |
- |
8±4 |
- |
3±1 |
- |
256 |
11±5 |
- |
27±6 |
- |
9±5 |
- |
5±2 |
|
D-HCl (5) |
647±28 |
- |
- |
- |
- |
- |
- |
- |
D-HCl (10) |
986±132 |
- |
- |
- |
- |
- |
- |
- |
2-AA |
- |
- |
- |
- |
- |
- |
- |
- |
SA (2.5) |
- |
- |
- |
- |
975±46 |
- |
- |
- |
SA (5) |
- |
- |
- |
- |
1446±144 |
- |
- |
- |
AAHC (50) |
|
|
|
|
|
|
184±14 |
|
AAHC (100) |
- |
- |
- |
- |
- |
- |
1581±456 |
- |
CP |
- |
- |
- |
- |
- |
- |
- |
- |
4-NQNO (0.125) |
- |
- |
740±72 |
- |
- |
- |
- |
- |
4-NQNO (0.25) |
- |
- |
1297±66 |
- |
- |
- |
- |
- |
D-HCl: daunorubicin-HCl
2-AA: 2-aminoanthracene
MNNG: N-methyl-N-nitro-N-nitrosoguanidine
CP: cyclophosphamide
4-NQNO: 4-nitroquinoline-N-oxide
AAHC: 9(5)-aminoacridine-hydrochloride
SA: sodium azide
(n.g.): not given
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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