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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test was based on OECD Guideline for Testing of Chemicals [No.471. Bacterial Reverse Mutation Test(Ames test), July. 1997]. This final report and the original raw data were reviewed for adherence to ISO/IEC17025: 2005 General Requirements for the competence of Testing Calibration Laboratories. OECD Guideline for Testing of Chemicals (No.471. Bacterial Reverse Mutation Test(Ames test), July. 1997);State Environmental Protection Administration : The Guidelines for the Testing of Chemicals ; Ministry of Health, 2005: Technical standards for testing of chemicals .

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Histidine requiring strains of salmonella typhimurium TA97, TA98, TA100 and TA102.
Species / strain
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
0.5ml of S9-mixture. The used active system is a cofactor-supplemented post-mitochondrial fraction (S9-mix). The used concentrations of S9-mix are 18.5%(v/v) in final concentration.
Test concentrations with justification for top dose:
According to the preliminary experiment,which indicated that antibacterial effects were found to the tested bacteria at the concentrations of 5000 and 2500 μg/plate, this study set four lower concentrations for the tested substance, the final concentrations were 1250, 625, 312 and 156 μg/plate separately.
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
CAS: 26628-22-8
Positive controls:
yes
Positive control substance:
other: 2-aminofluorene
Remarks:
CAS: 153-78-6
Positive control substance:
other: fenaminosulf
Remarks:
CAS: 140-56-7
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
CAS: 50-07-07
Positive controls:
yes
Positive control substance:
other: 1,8-dihydroxyanthraquinone
Remarks:
CAS: 117-10-2

Results and discussion

Test results
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

__

Results(X ±SD)

Table 1

Groups

Dosage*

g/plate)

With or not withS9

TA97

TA98

TA100

TA102

Spontaneous reverse mutation

-

Yes

140±12

35±3

154±11

263±14

No

153±13

37±3

181±15

291±23

Solvent control

-

Yes

157±9

36±4

152±12

280±18

No

163±16

40±2

169±7

287±9

Test substance

1250

Yes

142±11

33±3

115±4

164±16

No

147±7

38±2

132±8

136±14

625

Yes

146±12

39±4

127±8

212±5

No

141±15

36±2

145±11

157±11

312

Yes

137±5

38±5

129±5

201±10

No

155±6

39±2

156±15

141±19

156

Yes

144±13

37±2

151±4

172±13

No

151±13

35±1

140±6

138±13

Positive controls

Sodium azide (1.5μg/plate)

Yes

-

-

2286±115

-

No

-

-

-

-

2-Aminofluorene (10.0μg/plate)

Yes

-

-

-

-

No

2030±88

1973±96

1758±124

-

Fenaminosulf (50.0μg/plate)

Yes

1838±114

1764±98

-

-

No

-

-

-

-

Mitomycin C

(4.0μg/plate)

Yes

-

-

-

1848±136

No

-

-

-

-

1,8-Dihydroxyanthraquinone (50.0μg/plate)

Yes

-

-

-

-

No

-

-

-

1070±104

Note: *:According to the preliminary experiment,which indicated that antibacterial effects were found to the tested bacteria at the concentrations of 5000 and 2500μg/plate, this study set four lower concentrations for the tested substance.- means not available.

 

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

pepton 22 has been shown to be not mutagenic