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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
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
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

Constituent 1
Chemical structure
Reference substance name:
4-methylanisole
EC Number:
203-253-7
EC Name:
4-methylanisole
Cas Number:
104-93-8
Molecular formula:
C8H10O
IUPAC Name:
1-methoxy-4-methylbenzene
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