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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to GLP and guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
AMES II assay as described in Gee, P. et al. (4) and on the "Users Manual" prepared by XENOMETRIX, Inc., Colorado, USA. Used tester strains: TA 98, 7001, 7002, 7003, 7004, 7005, 7006.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Methoxy-6-methylbenzoic acid
EC Number:
612-182-4
Cas Number:
6161-65-5
Molecular formula:
C9H10O3
IUPAC Name:
2-Methoxy-6-methylbenzoic acid
Details on test material:
- name of test substance: BAS 560 F -(Benzoe-)Säure
- test substance number: 01/0246-1
- batch number: 30529/006
- CAS number: 6161-65-5
- date of manufacture: march 23, 2001
- purity: 99.49% (HPLC)
- appearance, consistency: white-brownish powder
- storage: room temperature

Method

Target gene:
his
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: 7001-7006
Species / strain / cell type:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S-9 mix.
Test concentrations with justification for top dose:
4 - 5,000 µg/mL
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Remarks:
Sterility and vehicle control.
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene, 2-nitrofluorene, 4-nitroquinoline-N-oxide
Evaluation criteria:
The test chemical is considered positive in this assay if the following criteria are met:
A dose-related increase in the number of positive wells by a factor of abaut 2 (calculated primarily an the basis of baseline data) in at least one tester strain either without S-9 mix or after adding a metabolizing system.

A test substance is generally considered non-mutagenic in this test if:
The number of revertant wells for all tester strains were within the historical negative control range under all experimental conditions.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: 7001-7006
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

- No test substance precipitation was found.

- No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) was observed.

Strain: TA 98
without S-9 mix
dose [µg/mL] RCSP 1 RCSP 2 RCSP 3 MEAN MEAN *c SD 1F 2F 3F
DMSO 6 8 6 6.7 6.7 0.94 1 0.9 1
4 5 2 4 3.7 1.25 0.6 0.5 0.6
20 3 6 4 4.3 1.25 0.7 0.6 0.7
100 4 7 3 4.7 1.7 0.7 0.6 0.7
500 5 4 2 3.7 1.25 0.6 0.5 0.6
2500 4 8 2 4.7 2.49 0.7 0.6 0.7
5000 4 8 2 4.7 2.49 0.7 0.6 0.7
4-NQO + 2-NF 29 26 34 29.7 3.3 4.5 3.9 4.6
with S-9 mix (3:7)
dose [µg/mL] RCSP 1 RCSP 2 RCSP 3 MEAN MEAN *c SD 1F 2F 3F
DMSO 4 7 7 6 6 1.41 1 0.8 0.9
4 3 5 4 4 0.82 0.7 0.5 0.6
20 7 7 2 5.3 2.36 0.9 0.7 0.8
100 6 4 2 4 1.63 0.7 0.5 0.6
500 5 3 3 3.7 0.94 0.6 0.5 0.5
2500 4 3 6 4.3 1.25 0.7 0.6 0.6
5000 3 5 1 3 1.63 0.5 0.4 0.4
2-AA 48 48 48 48 0 8 6.5 7.1
Strain: TA Mix (7001-7006)
without S-9 mix
dose [µg/mL] RCSP 1 RCSP 2 RCSP 3 MEAN MEAN *c SD 1F 2F 3F
DMSO 1 0 3 1.3 1.3 1.25 1 0.5 0.7
4 1 0 1 0.7 0.47 0.5 0.3 0.4
20 0 0 0 0 0 0 0 0
100 0 0 0 0 0 0 0 0
500 2 1 0 1 0.82 0.8 0.4 0.6
2500 1 0 1 0.7 0.47 0.5 0.3 0.4
5000 0 1 1 0.7 0.47 0.5 0.3 0.4
4-NQO + 2-NF 29 33 38 33.3 3.68 25 12.9 18.4

Strain: TA Mix (7001-7006)

dose [µg/mL] RCSP 1 RCSP 2 RCSP 3 MEAN MEAN *c SD 1F 2F 3F
DMSO 2 1 1 1.3 1.3 0.47 1 0.7 0.8
4 0 1 1 0.7 0.47 0.5 0.4 0.4
20 1 0 0 0.3 0.47 0.3 0.2 0.2
100 1 2 0 1 0.82 0.8 0.6 0.6
500 1 0 2 1 0.82 0.8 0.6 0.6
2500 1 1 0 0.7 0.47 0.5 0.4 0.4
5000 1 0 2 1 0.82 0.8 0.6 0.6
2-AA 34 30 31 31.7 1.7 23.8 17.5 18.1
RCSP = revertant colony selection plate (384-well).
SD = standard deviation
MEAN = mean of replicates
MEAN *c = mean corrected : < 1 = 1
F = factor
1F = based on mean *c
2F = baseline data / based on mean *c + SD
3F = baseline data / based on mean + SD of a run
4-NQO + 2-NF = 4-nitroquinoline: 0.0625 µg/mL + 2-nitroflourene 0.25 µg/mL
2-AA = 2-aminanthracene: 5.0 µg/mL

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Based o the results of this study, the test substance is not mutagenic in the AMES II Assay.