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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Repeated dose toxicity study in rats
- Author:
- E. C. HAGAN et. al.
- Year:
- 1 967
- Bibliographic source:
- Food and cosmetic toxicology, 1967
- Reference Type:
- review article or handbook
- Title:
- Repeated dose toxicity study of test chemical in rats
- Author:
- US National Library Of Medicine
- Year:
- 2 020
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2020
- Reference Type:
- other: Secondary source
- Title:
- Repeated dose toxicity study of test chemical on rats
- Author:
- The Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- Year:
- 1 980
- Bibliographic source:
- WHO Food Additives Series - 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- 13 weeks repeated oral toxicity study of test chemical in rats.
- GLP compliance:
- not specified
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Details on species / strain selection:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: The animals were housed individually in wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To:not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- stomach tube
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): Fresh diets were made and distributed weekly
- Mixing appropriate amounts with (Type of food): The concentration of the solution was adjusted for each level so that all rats received a constant volume of 1 ml of solution/kg daily
- Storage temperature of food: Not specified
VEHICLE
- Justification for use and choice of vehicle (if other than water): The test chemical was soluble in corn oil
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage): Not specified
- Lot/batch no. (if required): Not specified
- Purity:Not specified - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- 0 ppm
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- 1000 ppm
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- 10000 ppm
- No. of animals per sex per dose:
- Total: 40 animals
Test group: 10 males and 10 females
Control group: 10 males and 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- The rat's weight, food intake and general condition were recorded every week. Haematological examinations were made at 3, 6, 12 and 22 months in the chronic experiments. These examinations included white cell counts, red cell counts, haemoglobins and haematocrits.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
At the termination of the experiments the rats were sacrificed and exsanguinated - Other examinations:
- The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10 ~o buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Tissues from rats dying during the experiment were examined for gross changes and were preserved if autolysis was not advanced. Organs were
not weighed but abnormalities and the suspected reason for death were noted. - Statistics:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- haematology
- mortality
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) is considered to be 500 mg / kg body weight when male and female rats were orally treated with test substance for chronic study.
- Executive summary:
13 weeks repeated oral toxicity study was performed on rats to determine the toxic nature of test chemical. The study was performed on 10 male and 10 female Osborne-Mendel rats, a control group containing the same number of rats as the test groups was included with test compound. The animals were housed individually in wire cages and had access to food and water at all times. The test chemical was administered via stomach tube in corn oil solution at a dose range of 0, 1,000 and 10,000 ppm (approximately equivalent to 50 and 500 mg/kg bw). The concentration of the solution was adjusted for each level so that all rats received a constant volume of 1 ml of solution/kg daily. The control animals were given an equal volume of corn oil. The rat's weight, food intake and general condition were recorded every week. Hematological examinations were made at 3, 6, 12 and 22 months. These examinations included white cell counts, red cell counts, hemoglobin and hematocrits. At the termination of the experiments the rats were sacrificed and exsanguinated. The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10 % buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Tissues from rats dying during the experiment were examined for gross changes and were preserved if autolysis was not advanced. Organs were not weighed but abnormalities and the suspected reason for death were noted. After 13 weeks, No adverse effects were observed on body weights, appearance, food intake, hematology, organ weights, macroscopic or microscopic (at highest dietary level) examination of the major organs. Pathological changes attributable to disease or age were observed. Thus based on observations, No Observed Adverse Effect Level (NOAEL) is considered to be 500 mg / kg body weight indicating that the test chemical is not toxic in nature.
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