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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
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: 111. Results from the Testing of 255 Chemicals
Author:
Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, Kristien Mortelmans, and William Speck
Year:
1987
Bibliographic source:
Environmental Mutagenesis Volume 9, Supplement 9:l-110,1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Brucin in Salmonella typhimurium strains TA98, TA100,TA1535, and TA1537.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Brucine
Cas Number:
357-57-3
Molecular formula:
C23H26N2O4
IUPAC Name:
Brucine
Details on test material:
Details on test material
- Name of test material (as cited in study report): Brucin
- Molecular formula: C23H26N2O4
- Molecular weight: 394.4684g/mol
- Substance type: Organic
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report): Brucin
- Molecular formula: C23H26N2O4
- Molecular weight: 394.4684g/mol
- Substance type: Organic

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: strains TA98, TA100, TA1535, and TA1537
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared
Test concentrations with justification for top dose:
0-6666 µg/plate
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: 95% ETHANOL
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
95% ETHANOL
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
other: -S9 9-aminoacridine (TA97 and TA 1S37), and 4-nitro-o-phenylenediamine (TA98). +S9 2-aminoanthracene for all strains.
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Preincubation assay
Rationale for test conditions:
Not specified.
Evaluation criteria:
A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it
produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials
Statistics:
Standard deviation was observed.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: strains TA98, TA100, TA1535, and TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Although there were no specific response ranges established for the solvent and positive controls, each laboratory rejected experiments in which the positive
control chemical did not produce a mutagenic response or in which the solvent control values were higher (or lower in the case of TAl00 and TA97) than their expected values.
Remarks on result:
other: No mutagenic effect were observed

Any other information on results incl. tables

BRUClNE effect on different strain of salmonella

 

 

                                                         TA 100

Dose

                  NA

                   (-)

          10% HLI

                 (-)

         10% W

                (-)

 

Mean

Sem

Mean

Sem

Mean

Sem

0.000

 

89

5.9

145

13.2

159

13.2

3.000

 

  

 

 

 

 

 

10.000

 

92

7.3

 

 

 

 

33.000

 

91  

3.5

277

10.3

284

7.8

100-000

 

106  

7.1

418

30.6

409

17.7

166.000

 

 

 

 

 

523

69.4

 

 

333.000

 

113 

6.2

769

91.6

792

19.8

666.000

 

107

8.8

 

 

 

 

1000.000

 

 

 

1143 

203.3

1200

26.5

1666.000

 

 

 

 

 

 

 

 

2000.000

 

 

1445

36.2

 

 

POS

 

361 

20.4

1490

135.4

586

21.1

 

 

 

 

 

 

 

 

                                                         TA 1535

Dose

                  NA

                   (-)

          10% HLI

                 (-)

         10% W

                (-)

 

Mean

Sem

Mean

Sem

Mean

Sem

0.000

 

29          

3.5

14

3.8

9

1 . 5

3.000

 

  

 

28 

5.3

15

0.6

10.000

 

30  

1.7

40

2.5

26

4.2

33.000

 

33  

7.7

135

4.3

85

2.6

100.000

 

40   

2.2

328

5.5

227

6.6

166.000

 

54

5.0

 

 

 

 

 

 

333.000

 

64   

2.7

808

15.1

617

6.8

666.000

 

 

 

 

 

 

 

1000.000

 

 

 

 

 

 

 

1666.000

 

 

 

 

 

 

 

 

2000.000

 

 

 

 

 

 

POS

 

331 

14.6

484

23.3

133

8.5

 

 

 

 

 

 

 

 

 

 

                                                         TA 97

Dose

                  NA

                   (-)

          10% HLI

                 (-)

         10% W

                (-)

 

Mean

Sem

Mean

Sem

Mean

Sem

0.000

 

               98

4.3

171

2.5 

157

9.5

3.000

 

          106

6.4

 

 

 

 

10.000

 

112

1.2

180

11.6 

150

12.5

33.000

 

96

4.3

183

9.0 

157

8.1

100.000

 

63

4.9

186

0.3 

172

8.7

166.000

 

 

 

 

 

 

 

 

 

333.000

 

35s

3.6

 

 

 

 

666.000

 

 

 

 

 

 

 

1000.000

 

 

 

176 

6.4

156

14.6

1666.000

 

 

 

 

 

53s

6.3

 

2000.000

 

 

182

3.1

 

 

POS

 

11353

56.7

1730

34.3 

884

24.2

 

 

 

 

 

 

 

 

 

 

                                                         TA 1535

Dose

                  NA

                   (-)

          10% HLI

                 (-)

         10% W

                (-)

 

Mean

Sem

Mean

Sem

Mean

Sem

0.000

 

  17

1.0

26

4.8 

29

3.2

3.000

 

  14

0.9

 

 

 

 

10.000

 

13

0.9

39

5.9 

22

1.5

33.000

 

10

1.0

32

2.3 

22

2.1

100.000

 

6

0.3

34

4.6

I8

1.2

166.000

 

0s

00

 

 

 

 

 

 

333.000

 

 

 

25

6.7

13

3.5

666.000

 

 

 

 

 

0s

00

1000.000

 

 

 

22

2.8

 

 

1666.000

 

 

 

 

 

 

 

 

2000.000

 

 

 

 

 

 

POS

 

1461

22.3

993

39.6 

315

4.7

 

Applicant's summary and conclusion

Conclusions:
Brucin (357-57-3) was evaluated for its mutagenic potential in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 by Bacterial reverse mutation Assay. The test result was considered to negative in the presence and absence of S9.
Executive summary:

Brucin was assessed for its possible mutagenic potential. For this purposeBacterial reverse mutation Assay was performed on Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 .The test material was exposed at the concentration of 0-6666 µg/plate in the presence and absence of S9. No mutagenic effects were observed in all strain. Therefore Brucin was considered to be non mutagenic inSalmonella typhimurium strains TA98, TA100, TA1535, and TA1537. Hence the substance cannot be classified as gene mutant in vitro.