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EC number: 204-287-5 | CAS number: 118-92-3
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Anthranilic acid
- EC Number:
- 204-287-5
- EC Name:
- Anthranilic acid
- Cas Number:
- 118-92-3
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 2-aminobenzoic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain specifics: ICR
- Source: Harlan Sprague Dawley, Inc., Frederick, MD
- Age at study initiation: 6-8 weeks
- Weight at study initiation: males: 28.2 - 36.6 g, females: 24.0 - 38.5 g (micronucleus assay)
- Housing: in groups of five in plastic autoclavable cages with filter topx.in fully air-conditioned room, heat-treated hardwood chips
- Diet (e.g. ad libitum): rodent chow (Purina Certified Rodent Chow 5002), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 74 ± 6 °F
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 1 % sodium carboxymethyl cellulose
- Amount of vehicle (if gavage or dermal): 20 ml/kg body weight - Duration of treatment / exposure:
- treatment: once orally
exposure: animals were killed 24 or 48 h after administration
positive control: 24 h - Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
750 mg/kg bw male; 600 mg/kg bw female
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1500 mg/kg bw male; 1200 mg/kg bw female
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
3000 mg/kg bw male; 2400 mg/kg bw female
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males and 5 females per low and medium dose group, 23 males and 23 females for high dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 60 mg/kg body weight cyclophosphamide (Endoxan (R), 5 males and 5 females); dissolved in distilled water
Examinations
- Tissues and cell types examined:
- polychromatic and normochromatic erythrocytes from the femoral bone marrow of each animal
- Evaluation criteria:
- 1000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded. As a control measure 1000 mature erythrocytes were also counted and examined for micronuelei. In addition, the ratio of polychromatic to normochromatic erythrocytes was determined. The number of polychromatic erythrocytes with micronucIei occurring in the 1000 polychromatic erythrocytes counted, and the number of normocytes with micronuclei occurring in the 1000 normocytes counted, were evaluated statistically; comparison of dose groups with the simultaneous control group was performed according to Wilcoxon (paired, one-sided, increase) .
The results of the treatment groups (test substance) in the micronucleus test at each dose and killing time were compared with corresponding control values.The ratio of polychromatic to normochromatic erythrocytes was also evaluated statistically by the method of Wilcoxon (paired, two sided). All statistical results are based on a 95% level of significance. Actual data were also compared with historical controls. - Statistics:
- Statistical significance was determined using the Kastenbaum-Bowman tables
All statistical results are based on a 95% level of significance.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- At high dose levels 12/23 (male) and 14/23 (female) mortality was observed. The following signs of toxicity were observed at medium and high dose levels: lethargy
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Oral administration of the test item did not lead to a substantial increase of micronucleated polychromatic and normochromatic erythocytes and was not mutagenic in the in vivo micronucleus test - Executive summary:
The test item was tested in the micronucleus test according to OECD 474. The substance was dissolved in sodium carboxymethyl cellulose and dosed once orally at doses of 750, 1500, 3000 mg per kg bodyweight to male and 600, 1200, 2400 mg/kg bw female mice, upon the results of the previously conducted dose range finding assay. The animals were killed 24 or 48 h after administration.
The number of polychromatic and normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with the test item and was statistically not different from the control values.
EndoxanRwas used as positive control substance and was administered orally at a dose of 60 mg per kg bodyweight.
EndoxanR induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity af the system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extent.The results indicate that, under the conditions of the present study, the test item is not mutagenic in the micronucleus test.
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