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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-618-6 | CAS number: 2835-95-2
- 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets basic scientific principles, non GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute oral toxicity or LD50 value was determined by administration of test substance to 4 dose groups (5 rats/sex/group). Subsequently, observations of effects such as mortality and clinical signs were made for 14 days. Body weights were measured prior to dosing, and on Day 7 and 14 of dosing. A gross necropsy was performed on the day of death or after terminal sacrifice on all animals.
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5-amino-o-cresol
- EC Number:
- 220-618-6
- EC Name:
- 5-amino-o-cresol
- Cas Number:
- 2835-95-2
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 5-amino-2-methylphenol
- Reference substance name:
- 4-Amino-2-Hydroxy Toluene
- IUPAC Name:
- 4-Amino-2-Hydroxy Toluene
- Test material form:
- not specified
- Details on test material:
- - Name of test material: 4-Amino-2-Hydroxy Toluene
- TSIN #: Not reported
- Substance type: Pure active substance
No other information on details on test material was provided in the study report.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CFY strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 90-119 g
- Fasting period before study: Overnight before treatment
No other information on test animals was provided in the study report.
ENVIRONMENTAL CONDITIONS
No information on environmental conditions was provided in the study report.
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous gum tragacanth (0.5%) containing sodium sulphite (0.05%)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% suspension in aqueous gum tragacanth (0.5%) containing sodium sulphite (0.05%).
MAXIMUM DOSE VOLUME APPLIED: 64 mL/kg bw
DOSAGE PREPARATION: The test substance was prepared as a 10% suspension in aqueous gum tragacanth (0.5%) containing sodium sulphite (0.05%). - Doses:
- Range finding study: 0, 400, 1000, 2500 and 6400 mg/kg bw
Main study: 0, 1600, 2500, 4000, 6400 mg/kg bw - No. of animals per sex per dose:
- Range finding study: 2 animals/sex/dose group
Main study: 5 animals/sex/dose group - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortalities and signs of toxicity daily for 14 days. Body weights were measured prior to dosing, and on Day 7 and 14 of dosing.
- Necropsy of survivors performed: Yes, a gross necropsy was performed on the day of death or after terminal sacrifice on all animals. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage. - Statistics:
- The LD50 and its 95% confidence limits were calculated from the mortality data by the method of Weil C.S. (1952). Biometrics, 8, 249.
Results and discussion
- Preliminary study:
- - No mortalities were observed at any dose levels except at the highest dose level (6400 mg/kg bw) where all animals died in less than 26 hours. The results of preliminary range finding tests indicated that the median lethal oral dose (LD50), was in the region of 2500 to 6400 mg/kg bw. Dosing was then extended to larger groups of rats (five males and five females) in order to locate the median lethal dose more precisely in the main test.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 100 - 4 000
- Mortality:
- - Mortality observed at individual dose levels was as follows:
- 1600 mg/kg bw: 0/5 male and 0/5 female;
- 2500 mg/kg bw: 0/5 male and 0/5 female;
- 4000 mg/kg bw: 4/5 males and 4/5 females;
- 6400 mg/kg bw: 5/5 males and 5/5 females - Clinical signs:
- other: - Signs of reaction to treatment observed shortly after dosing, included lethargy, piloerection and decreased respiratory rate. These sign were accompanied by ataxia in rats treated above 1600 mg/kg bw and by fine body tremors and increased lacrimation in
- Gross pathology:
- - Autopsy revealed darkening of the liver, kidneys, and spleen and injection of mesenteric and intestinal blood vessels. Necropsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal oral dose of 4-amino-2-hydroxytoluene in rats was determined to be 3600 (95% confidence limits: 3100-4000) mg/kg bw. No classification applied according to CLP regulation.
- Executive summary:
The objective of this study was to determine the acute toxicity of 4-Amino-2-hydroxytoluene after oral administration.
Male and female rats of CFY strain weighing between 90-119 g were used in the study. Animals were fasted before treatment. The test substance was prepared as a 10% suspension in aqueous gum tragacanth (0.5%) containing sodium sulphite (0.05%).
In the range finding study, 2 rats/sex/dose were administered the test substance via gavage at dose levels of 0, 400, 1000, 2500 and 6400 mg/kg bw. Mortalities were observed only at the highest dose level (6400 mg/kg bw) where all animals died in less than 26 hours. The results of preliminary range finding tests indicated that the median lethal oral dose (LD50), was in the region of 2500 to 6400 mg/kg bw. Dosing was then extended to larger groups of rats (five males and five females) in order to locate the median lethal dose more precisely in the main test.
In the main study, 5 rats/sex/dose were administered the test substance via gavage at dose levels of 0, 1600, 2500, 4000 and 6400 mg/kg bw. Animals were observed for mortalities and signs of toxicity daily for 14 days. Slightly depressed bodyweight gain was observed during the first week of observation in the surviving female rat treated at 4000 mg/kg, but returned to normal during the second week of observation compared with controls. Body weight gain was normal in rest of the test group animals.
Shortly after dosing clinical signs observed were lethargy, piloerection and decreased respiration rate. These signs were accompanied by ataxia in rats treated above 1600 mg/kg bw and by fine body tremors and increased lacrimation in rats treated above 2500 mg/kg bw. Recovery of animals, as judged by external appearance and behaviour, was apparently complete within six days of treatment.
Mortality observed at individual dose levels was as follows:
- 1600 mg/kg bw: 0/5 male and 0/5 female;
- 2500 mg/kg bw: 0/5 male and 0/5 female;
- 4000 mg/kg bw: 4/5 males and 4/5 females;
- 6400 mg/kg bw: 5/5 males and 5/5 females
Autopsy of animals who died during the study revealed darkening of the liver, kidneys, and spleen and injection of mesenteric and intestinal blood vessels. Terminal necropsy findings were normal.
Based on above, The acute median lethal oral dose of 4-amino-2-hydroxytoluene in rats was determined to be 3600 (95% confidence limits: 3100-4000) mg/kg bw.
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.