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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles with acceptable deviations. No E. coli strain or S. typh. TA102 used.

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:
in the first mutation test, data was provided for 4 bacterial strains only (due to contamination in the 5th strain).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Methylanisole
- Analytical purity: no data given

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA100, TA1535, TA1538, TA98 and TA1537
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
- First mutation test: 10, 1, 0.1, 0.01 µl/plate
- Repeat test: 0.1, 0.01, 0.001, 0.0001 µl/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: TA 1535/100 sodium azide (5µg/plate); -S9: TA 1537/1538/98 4-nitro-o-phenylenediamine (500µg/plate); +S9: TA 1535/98/100 2-amino-anthracene (2 µg/plate); +S9: TA 1537 Neutral red (10 µg/plate); +S9: TA 1538 2-acetyl-aminofluorene (20 µg/plate)
Details on test system and experimental conditions:
DETERMINATION OF CYTOTOXICITY
- Method: other: Bacteriostatic test assessing zone of inhibition; assessment of bacterial lawn

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA100, TA1535, TA1538, TA98 and TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >= 1 µl /plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
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: Maximum revertants/plate and corresponding test concentrations in the1st mutation test:

Strain

Tested compound

Maximum revertants/plate [corresponding dose unit in µg/plate]

 

 

without S9-mix

with S9-mix

S. typhimurium TA1535

vehicle control

16

15

Test substance

15 [0.1]

14 [0.1]

Positive Control

721

 408

S. typhimurium TA1537

vehicle control

7

 7

Test substance

[0.01]

[0.1]

Positive Control

115

141

S. typhimurium TA1538

vehicle control

15 

15

Test substance

16 [0.1]

15 [0.01]

Positive Control

529

448

S. typhimurium TA98

vehicle control

34

36

Test substance

36 [0.1]

36 [0.1]

Positive Control

1111

617

S. typhimurium TA100

vehicle control

contamination

contamination

Test substance

contamination

contamination

Positive Control

contamination

contamination

Table 2: Maximum revertants/plate and corresponding test concentrations in therepeat test:

Strain

Tested compound

Maximum revertants/plate [corresponding dose unit in µg/plate]

 

 

without S9-mix

with S9-mix

S. typhimurium TA1535

vehicle control

16

12

Test substance

18 [0.0001]

14 [0.0001]

Positive Control

926

178

S. typhimurium TA1537

vehicle control

8

10

Test substance

10 [0.0001]

10 [0.001]

Positive Control

136

65

S. typhimurium TA1538

vehicle control

15

13

Test substance

13 [0.0001]

19 [0.0001]

Positive Control

1158

183

S. typhimurium TA98

vehicle control

39

31

Test substance

42 [0.001]

32 [0.0001]

Positive Control

1600

contaminated

S. typhimurium TA100

vehicle control

86

68

Test substance

92 [0.0001]

71 [0.0001]

Positive Control

644

contaminated

Applicant's summary and conclusion