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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 TA strains; purity not specified
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
No detail provided

Method

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:
1 ml activation mixture contains: 0.3 ml S9 fraction of liver from rats induced with Aroclor 1254 and 0.7 ml of a solution of co-factors
Test concentrations with justification for top dose:
25, 75, 225, 675 and 2025 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Without S9: TA 98 (daunorubicin- HCl, 5 and 10 µg/plate); TA 100 (4-nitroquinoline-N-oxide, 0.125 and 0.25 µg/plate; TA 153 5 (N-methyl-N'-nitro-N-nitrosoguanidine, 3 and 5 µg/plate;
Remarks:
Positive control substances without S9 (continue) TA 1537 (9[5]aminoacridine hydrochloride monohydrate, 50 and 100 µg/plate. With S9: TA 1535 (cyclophosphamide, 250 µg/plate).
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation), in triplicates

DURATION
- Exposure duration: 48 hours at 37 °C

SELECTION AGENT (mutation assays): histidine deprivation

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
Evaluation criteria:
Doubling of the colony number is given as a cut-off value in the report.
Statistics:
When the colonies had been counted, the arithmetic mean was calculated.

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
Remarks:
no marked differences (number of revertants) in test groups in comparison with the negative control treatment
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mean number of revertants

Metabolic activation

Test substance concentration (µg/plate)

Mean number of revertant

TA 98

TA 100

TA 1535

TA 1537

 

 

Without S9

0

26

133

12

5

25

23

152

21

7

75

23

151

12

4

225

26

149

14

3

675

25

150

15

4

2025

21

152

12

5

 

 

With S9

0

40

148

13

4

25

40

138

16

7

75

43

166

14

6

225

37

156

14

7

675

46

154

13

10

2025

41

149

14

6

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative