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EC number: 220-621-2 | CAS number: 2835-99-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 27, 1979 to July 20, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, followed methods similar to guideline, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute oral toxicity (LD50) of test substance was determined in female mice, by a single oral administration of test substance at six dose levels. After treatment, animals were observed for clinical signs, cage side observation and mortality for 14 days. A gross necropsy was performed on all animals on the day of death or after terminal sacrifice. The method followed in the study was comparable to the OECD 401 guideline.
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-m-cresol
- EC Number:
- 220-621-2
- EC Name:
- 4-amino-m-cresol
- Cas Number:
- 2835-99-6
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 4-amino-m-cresol
- Reference substance name:
- 1-Hydroxy-3-methyl-4-aminobenzene
- IUPAC Name:
- 1-Hydroxy-3-methyl-4-aminobenzene
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: 1-Hydroxy-3-methyl-4-aminobenzene
- TSIN: Not reported
- Substance type: Pure active substance
- Physical state: Beige, fine crystalline powder
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals of SPF breed were obtained from Winkelmann Inc.
- Age at study initiation: Not reported
- Weight at study initiation: In the range of 21-32 g
- Fasting period before study: Animals were fasted for 16 hour prior to treatment.
- Housing: Animals were housed in a group of 5 animals each in Makrolon type III cages from Ebeco Inc., with standard bedding from Ssniff Inc.
- Diet: Standard laboratory diet from Altromin Inc, ad libitum.
- Water: Drinking water, ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature: 20±2°C
- Humidity: 50±5% (maximum deviation)
- Air changes: Approximately 15-fold air exchange per hour
- Photoperiod: Alternating light-dark periods of 12 hours each
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspended in 10% gum arabic
- Details on oral exposure:
- VEHICLE: No details on vehicle were provided in the study report.
MAXIMUM DOSE VOLUME APPLIED: Not reported
DOSAGE PREPARATION: The dosing formulation was prepared in 10% gum arabic
- Rationale for the selection of the starting dose: The doses were selected based on the results of preliminary study. - Doses:
- 750, 800, 850, 900, 950 and 1000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weights were determined on weekly basis.
- Necropsy of survivors performed: Yes, all animals were necropsised at the end of the experiment and during the experiment in the case of mortalities, respectively.
- Other examinations performed: The other observations were as follows:
a) Mortality: Daily
b) Clinical-toxicological observations: Daily - Statistics:
- LD50 values were calculated by the method of Spearman-Kärber.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 908 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 743 - 1 073
- Mortality:
- - Deaths occurred within 2- 48 hours after substance administration.
For details on mortality, refer ‘Table 1’ provided in the section 'Any other information on results incl. tables'. - Clinical signs:
- - In the treated animals, reduction of the physical activity was observed.
- Body weight:
- No detailed information on body weight was provided in the study report.
- Gross pathology:
- - At necropsy no macroscopic organ changes/damages were observed.
Any other information on results incl. tables
Preliminary study: A range finding study was performed to select the doses for main study, by using 6 female mice. The results of the preliminary experiment revealed that the median lethal dose (LD50) must be in the range between 0.5 and 1.5 g/kg. Respective dosage was extended in the main experiment to a larger number of animals for a more precise determination of the median lethal dose.
Table 1. Mortality after treatment with 1-Hydroxy-3-methyl-4-aminobenzene (study # 83525)
Dose (mg/kg bw) |
Mortalities |
750 |
0/6 |
800 |
1/6 |
850 |
3/6 |
900 |
1/6 |
950 |
3/6 |
1000 |
6/6 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity (LD50) of 1-Hydroxy-3-methyl-4-aminobenzene when administered once orally to CF1 mouse was 908 mg/kg bw.
- Executive summary:
The purpose of the study was to determine the acute oral toxicity (LD50) of 1-Hydroxy-3-methyl-4-aminobenzene after a single oral administration to mice.
CF1 female mice obtained from Winkelmann Inc. were used in the study. 6 animals were used in each treatment group. Animals were housed in groups of 6 animals in each Makrolon type III cage. Animals were housed in controlled environment (Temperature: 20±2°C, humidity: 50±5% (maximum deviation), air changes: approximately 15-fold air exchange per hour, photoperiod: Alternating light-dark periods of 12 hours each).
A range finding study was performed, to determine the doses for the main study, in the dose range of 0.5 to 1.5 g/kg bw. Based on the results of the range finding study, the following doses were selected for the main study.
750, 800, 850, 900, 950 and 1000 mg/kg bw
Mortality and clinical signs were observed daily during the 14-day observation period. All animals were submitted to a gross necropsy at the end of the observation period.
Deaths occurred within 2-48 hours after treatment. The mortalities observed in different dose groups were as follows:
0/6, 1/6, 3/6, 1/6, 3/6 and 6/6 at dose levels of 750, 800, 850, 900, 950 and 1000 mg/kg bw, respectively.
In the treated animals, reduction of physical activity was observed. At necropsy, no macroscopic organ changes/damages were observed.
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