Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 205-132-4 | CAS number: 134-20-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Kristien Mortelmans et. al.
- Year:
- 1 986
- Bibliographic source:
- Environmental Mutagenesis, 1986
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:
- Determination of Gene mutation toxicity study of the test chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl o-aminobenzoate
- Cas Number:
- 134-20-3
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- Methyl o-aminobenzoate
- Test material form:
- liquid
- Details on test material:
- IUPAC name: 2-Aminobenzoic acid, methyl ester
Mol. formula: C8H9NO2
Molecular Weight: 151.1641 gm/mol
Smiles: c1(c(cccc1)N)C(OC)=O
InChI: 1S/C8H9NO2/c1-11-8(10)6-4-2-3-5-7(6)9/h2-5H,9H2,1H3
Constituent 1
Method
- Target gene:
- Histidine
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:
- The S-9 mixes were prepared immediately prior to use and contained 10% RLI and 10% HLI respectively.
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
- source of S9 : Male Sprague-Dawley rats and male Syrian hamsters
- method of preparation of S9 mix : Aroclor 1254 (200 mg/ml in corn oil) was administered ip at 500 mg/kg 5 days prior to decapitation (EGG, SRI) or cervical dislocation (CWR). The animals were deprived of food 12-24 hr immediately preceding death; otherwise food and water were provided ad libitum. The livers were removed aseptically, washed in ice-cold 0.15 M KCl, and minced and homogenized (3 ml of 0.15 M KC1 per gm of wet tissue) in a Potter-Elvehjem apparatus with a Teflon pestle. CWR initially used a Waring blender, but switched to a Potter-Elvehjem apparatus. The S-9 fraction was obtained by centrifugation of the liver homogenate for 10 min at 9,000 g at 4°C. The S-9 fraction was dispensed into freezing ampules and stored in a -70°C freezer, or in liquid nitrogen.
- concentration or volume of S9 mix and S9 in the final culture medium : 0.5 ml
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): No data - Test concentrations with justification for top dose:
- 0.000, 33.000, 100.000, 333.000, 1000.000 and 1800.000 µg/plate
- Vehicle / solvent:
- Genetox: - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine for TA98, 2-aminoanthracene for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: At least five doses of the chemical were tested in triplicate. Experiments were repeated at least 1 wk following the initial trial
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER:
Preincubation method: The test chemical was assayed for mutagenicity in the preincubation assay. To each of 13 X 100-mm test tubes maintained at 37°C were added in the following order: 0.5 ml of S-9 mix or 0.1 M PO4 buffer (pH 7.4), 0.05 ml of the overnight culture, and 0.05 ml of solvent or chemical dilution. The mixture was mixed and allowed to incubate without shaking at 37°C for 20 min, at which time 2.0 ml (CWR, SRI) of molten (45°C) top agar supplemented with 0.5 mM L-histidine and 0.5 mM D-biotin were added. The contents of the tubes were mixed and poured onto 25 ml of minimal glucose bottom agar [Vogel and Bonner, 19561 in 15 X 100-mm plastic petri dishes. When the top agar had solidified, the plates were inverted and incubated at 37°C for 48 hr. Concurrent solvent and positive controls were tested with and without the metabolic activation systems. At least five dose levels of the chemicals were tested, with three plates per dose level. AU assays were repeated (as described above) no less than 1 wk after completion of the initial test.
Preliminary Dose-Setting Experiment:
The test chemical was initially tested with strain TA100 in the presence and the absence of the metabolic activation systems, over a wide dose range with an upper limit of 10 mg/plate, or less when solubility problems were encountered. Toxicity was evidenced by one or more of the following phenomena: appearance of his pin point
colonies, reduced numbers of revertant colonies per plate, or thinning or absence of the bacterial lawn. Nontoxic chemicals were tested in the initial experiment up to the 10 mg/plate dose level, or to a level determined by their solubility. Toxic chemicals were tested up to a high dose which exhibited some degree of toxicity. As a rule, at least one toxic dose was incorporated into the first mutagenicity test; the repeat test occasionally had the doses adjusted so that an apparent toxic dose was not reached. - Rationale for test conditions:
- No Data Available
- Evaluation criteria:
- The plates were observed for a dose related increase in the number of revertants
The criteria used for data evaluation can be summarized as follows:
1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) non mutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity. - Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- Water
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data available
- Remarks on result:
- other: No mutagenic potenrial observed
Any other information on results incl. tables
Tables
1.
Dose |
NA |
TA100 10% HLI |
10% RLI |
|||
µg/plate |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
0.000 |
145 |
10.2 |
118 |
5.6 |
138 |
8.6 |
33.000 |
132 |
8.5 |
126 |
15.3 |
143 |
4.2 |
100.000 |
132 |
5.5 |
130 |
1.7 |
118 |
9.6 |
333.000 |
141 |
6.1 |
119 |
10.0 |
131 |
6.6 |
1000.000 |
130 |
5.3 |
110 |
5.5 |
121 |
9.6 |
1800.000 |
t |
t |
t |
|
t |
|
Positive control |
1399 |
21.3 |
706 |
10.5 |
901 |
20.2 |
2.
Dose |
NA |
TA1535 10% HLI |
10% RLI |
|||
µg/plate |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
0.000 |
35 |
3.8 |
12 |
1.5 |
14 |
0.6 |
33.000 |
29 |
0.6 |
9 |
1.7 |
7 |
2.6 |
100.000 |
31 |
4.2 |
9 |
1.2 |
13 |
1.2 |
333.000 |
29 |
4.7 |
13 |
2.2 |
11 |
2.2 |
1000.000 |
13s |
1.2 |
9 |
0.3 |
11 |
0.3 |
1800.000 |
t |
|
t |
|
t |
|
Positive control |
1316 |
14.5 |
64 |
8.7 |
108 |
5.5 |
3.
Dose |
NA |
TA1537 10% HLI |
10% RLI |
|||
µg/plate |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
0.000 |
7 |
0.9 |
5 |
0.9 |
5 |
1.2 |
33.000 |
5 |
1.7 |
8 |
1.2 |
7 |
1.3 |
100.000 |
7 |
0.6 |
7 |
1.5 |
9 |
1.5 |
333.000 |
8 |
1.2 |
8 |
3.0 |
8 |
1.2 |
1000.000 |
2 |
0.9 |
8 |
1.5 |
8 |
0.9 |
1800.000 |
t |
|
6s |
0.5 |
5s |
1.0 |
Positive control |
171 |
3.7 |
100 |
7.0 |
81 |
6.2 |
4.
Dose |
NA |
TA98 10% HLI |
10% RLI |
|||
µg/plate |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
0.000 |
18 |
2.2 |
24 |
2.0 |
29 |
2.2 |
33.000 |
14 |
1.5 |
26 |
0.9 |
29 |
0.3 |
100.000 |
18 |
1.0 |
27 |
2.0 |
26 |
2.1 |
333.000 |
17 |
2.0 |
28 |
0.6 |
27 |
0.9 |
1000.000 |
13 |
1.2 |
24 |
2.1 |
24 |
1.5 |
1800.000 |
t |
|
14s |
0.9 |
t |
|
Positive control |
1267 |
44.6 |
949 |
94.4 |
670 |
26.3 |
t= toxic
s= slight toxic
Applicant's summary and conclusion
- Conclusions:
- The test chemical failed to induce mutation in the Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 in the presence and absence of S9 metabolic activation system and hence is not likely to classify for gene mutation in vitro.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed using Salmonella typhimurium strains TA98, TA1537, TA100 and TA1535 in the presence and absence of S9 metabolic activation system. The chemical was dissolved in DMSO as solvent and used at dose levels 0, 33, 100, 333, 1000 and 1800 µg/plate by the preincubation method. The liver S-9 was isolated from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Positive controls like sodium azide for TA1535 and TA 100, 4-nitro-o-phenylenediamine for TA98, and 9-aminoacridine for TA97 and TA1537; 2-aminoanthracene were used in the study. The test chemical failed to induce mutation in the Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 in the presence and absence of S9 metabolic activation system and hence is not likely to classify for gene mutation in vitro.
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.