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EC number: 209-711-2 | CAS number: 591-27-5
- 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
- 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 peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation toxicity in vivo study for the test chemical
- Author:
- Hossack and Richardson
- Year:
- 1 977
- Bibliographic source:
- Experentia
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vivo mammalian somatic cell study was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- other: In vivo mammalian somatic cell study: Micronucleus study
Test material
- Reference substance name:
- 3-aminophenol
- EC Number:
- 209-711-2
- EC Name:
- 3-aminophenol
- Cas Number:
- 591-27-5
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 3-aminophenol
- Details on test material:
- - Name of test material: 3-aminophenol
- Molecular formula: C6H6NO
- Molecular weight: 109.127 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CFY - descendants
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Anglia Laboratory Animals, Alconbury, Cambs., U.K.
- Age at study initiation: No data
- Weight at study initiation: 130-160 g
- Assigned to test groups randomly: Random allocation
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: The test chemical was prepared as suspensions in 0.5% (w/v) gum tragacanth containing 0.05% (w/v) sodium sulphite to give a dose range of 0 or 5000 mg/Kg.
- Justification for choice of solvent/vehicle: The test chemical was soluble in the solvent
- Concentration of test material in vehicle: 0 or 5000 mg/Kg
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- For oral route
PREPARATION OF DOSING SOLUTIONS: The test chemical was prepared as suspensions in 0.5% (w/v) gum tragacanth containing 0.05% (w/v) sodium sulphite to give a dose range of 0 or 5000 mg/Kg.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data - Duration of treatment / exposure:
- 24 hrs
- Frequency of treatment:
- Twice separated by an interval of 24 h
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- 0 or 5000 mg/Kg
- No. of animals per sex per dose:
- Total: 10 males and 10 females
0 mg/Kg: 5 males and 5 females
5000 mg/Kg: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The doses were selected on the basis of preliminary dose range finding study
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 6 h after the 2nd dose the animals were killed by the i.p.injection of pentobarbitone sodium (Expiral) the femurs dissected out and bone-marrow smears prepared.
DETAILS OF SLIDE PREPARATION: The smears were fixed in methanol, defatted in xylene and stained with Giemsa stain.
METHOD OF ANALYSIS: The stained smears were then examined microscopically to determine the incidence of micronucleated cells per 2000 polychromatic erythrocytes per animal. The group mean counts and ranges were then compared with the values obtained with the vehicle control group and with laboratory standard values.
OTHER: No data - Evaluation criteria:
- The group means counts and ranges of of micronucleated cells were compared with the values obtained with the vehicle control group and with laboratory standard values.
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: The total dosages given were determined in preliminary studies to be close to the lethal doses
- Solubility: No data
- Clinical signs of toxicity in test animals: No data
- Evidence of cytotoxicity in tissue analyzed: No data
- Rationale for exposure: No data
- Harvest times: No data
- High dose with and without activation: No data
- Other: No data
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data
- Induction of micronuclei (for Micronucleus assay): No data
- Ratio of PCE/NCE (for Micronucleus assay): No data
- Appropriateness of dose levels and route: No data
- Statistical evaluation: No data
Other: Agitation and/or convulsions, and/or lethargy were observed in the treated animals. Orange urine was also seen in treated animals.
Any other information on results incl. tables
Table:
Chemical |
Dose over 24 hrs (mg/Kg) |
Mortality |
Incidence of micronucleated cells per 2000 polychromatic erythroeytes per rat |
|
Mean |
Range |
|||
Vehicle control |
- |
0 |
1.8 |
0-5 |
Test chemical |
5000 |
3 |
1.9 |
0-4 |
Table 2. Rat micronucleus test Laboratory standard values for negative control groups
Total number of animals examined |
Mean micronucleated cell count |
Range of group mean counts |
Range of individual counts |
175 |
1.19 |
0.7-2.3 |
0-6 |
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not induce micronuclei formation in the bone marrow of male and female rats.
- Executive summary:
In vivo mammalian somatic cell study was performed to determine the mutagenic nature of the test chemical. The study was performed using male and female CFY strain rats. The test chemical was prepared as suspensions in 0.5% (w/v) gum tragacanth containing 0.05% (w/v) sodium sulphite to give a dose range of 0 or 5000 mg/Kg. The total dosages given were determined in preliminary studies to be close to the lethal doses, and were administered by gastric intubation as 2 equal doses separated by an interval of 24 h. 6 h after the 2nd dose the animals were killed by the i.p. injection of pentobarbitone sodium (Expiral) the femurs dissected out and bone-marrow smears prepared. The smears were fixed in methanol, defatted in xylene and stained with Giemsa stain. The stained smears were then examined microscopically to determine the incidence of micronucleated cells per 2000 polychromatic erythrocytes per animal. The group mean counts and ranges were then compared with the values obtained with the vehicle control group and with laboratory standard values.Agitation and/or convulsions, and/or lethargy were observed in the treated animals. Orange urine was also seen in treated animals.Based on the observations made,the test chemical did not induce micronuclei formation in the bone marrow of male and female rats.
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