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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
1984
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

Constituent 1
Chemical structure
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

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