Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-388-4 | CAS number: 120-35-4
Genetic toxicity: in vitro
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-amino-4-methoxybenzanilide
- EC Number:
- 204-388-4
- EC Name:
- 3-amino-4-methoxybenzanilide
- Cas Number:
- 120-35-4
- Molecular formula:
- C14H14N2O2
- IUPAC Name:
- 3-amino-4-methoxy-N-phenylbenzamide
- Details on test material:
- - Name of test material (as cited in study report): Amino-anisbase (gereinigt)
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254(R) induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Experiment I: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment II: 0, 4, 20, 100, 500, 2500, 5000 µg/plate without metabolic activation
0, 0.032, 0.16, 0.8, 4, 20, 100, 500 µg/plate with metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Na-azide, 9-Aminoacridine, 2-Nitrofluorene, N-Methyl-N-nitro-N-nitrosoguanidine, Benzo[a]pyrene, 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation)
DURATION
- Exposure duration: incubation for at least 48 to 72 hours
NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls, two independent experiments - Evaluation criteria:
- negative result: no significant and no dose dependant increase in the number of revertant colonies
- Statistics:
- Arithmetic means of the counted colonies were calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: visible precipitation of the test item on the plates has been observed at 2 500, 5 000 and 10 000 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. In the presence of metabolic activation, treatment of the cells with the test item resulted in relevant increases in the number of revertant colonies with the S. typhimurium strains TA 98, TA 100, TA 1537 and TA 1538.
The test compound proved to be toxic to most of the bacterial strains at 2 500 µg/plate.
Table 1: Results Experiment I TA 98, TA 100, TA 1537 and TA 1538 with metabolic activation
Dose µg/plate |
TA 98 |
TA 100 |
TA 1537 |
TA 1538 |
Number of colonies (mean) |
||||
0 |
38 |
153 |
13 |
14 |
4 |
264 |
1015 |
27 |
238 |
20 |
569 |
1646 |
83 |
509 |
100 |
889 |
1631 |
94 |
780 |
500 |
878 |
947 |
110 |
629 |
2 500 (precipitation) |
510 |
387 |
52 |
401 |
10 000 (precipitation |
308 |
410 |
1 |
115 |
Table 1: Results Experiment II TA 98, TA 100, TA 1537 and TA 1538 with metabolic activation
Dose µg/plate |
TA 98 |
TA 100 |
TA 1537 |
TA 1538 |
Number of colonies (mean) |
||||
0 |
25 |
177 |
16 |
19 |
0.032 |
33 |
190 |
X |
20 |
0.16 |
31 |
191 |
16 |
24 |
0.8 |
46 |
232 |
18 |
31 |
4 |
109 |
452 |
32 |
115 |
20 |
621 |
2877 |
96 |
661 |
100 |
889 |
2620 |
160 |
1188 |
500 |
X |
X |
142 |
X |
X: concentration not tested
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
The test item is mutagenic in S. typhymurium strains TA 98, 100, 1537 and 1538 in the presence of exogenous metabolic activation. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98, 100 and 1538 as well as Escherichia coli WP2 uvrA with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 4, 20, 100, 500, 2500, 5000 and 10 000 µg/plate. Under the conditions tested the test compound caused a significant increase in the number of revertant colonies in S. typhymurium TA 98, 100, 1537 and 1538 in the presence of metabolic activation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
