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EC number: 204-442-7 | CAS number: 121-00-6
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- 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 journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Repeated dose toxicity study of the test chemical
- Author:
- Kanga et al
- Year:
- 2 005
- Bibliographic source:
- Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- Repeated dose toxicity study was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Veterinary Research and Quarantine Service (Anyang, Korea).
- Age at study initiation: 20-days-old immature female
Housing: All animals were cared according to the guidelines for good animal laboratory practices prepared by National Veterinary Research and Quarantine Services.
- Diet (e.g. ad libitum): Commercial diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
Temperature (°C): 24±2 ◦C
- Humidity (%): 50±20%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-h
light/dark cycle
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- corn oil
- Details on exposure:
- BHA was dissolved in corn oil and diluted to dosages of 50, 100, 250 and 500 mg/kg
Area of exposure: dorsal surface, caudal to the nape of neck - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 100, 250 and 500 mg/kg
- No. of animals per sex per dose:
- Total : 76
0 mg/kg/body weight/day: 11 female
50 mg/kg/body weight/day: 11 female
100 0 mg/kg/body weight/day: 11 female
250 mg/kg/body weight/day: 11 female
500 mg/kg/body weight/day: 11 female
2 µg/kg + 50 mg/kg ( E2 +BHA): 7 female
2 µg/kg + 500 mg/kg ( E2 +BHA): 7 female
2 µg/kg (E2): 7 female - Control animals:
- yes, concurrent no treatment
- Details on study design:
- Dose selection rationale: Doses were referenced from NOEL (No observed effect level, 250 mg/kg) of BHA (WHO, 1989; Vorhees et al., 1981). Animals were assigned on the basis of age.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Daily
CLINICAL CHEMISTRY: Yes
All 76 rat were examined - Statistics:
- Body weight gain, organ weights, consumption of feed and water, uterine epithelial cell height and hormone contents were analyzed by one-way analysis of variance with post hoc comparison between the vehicle control or positive control group and each treatment group, followed by Duncan’s multiple comparison using Statistica program (Version 5.5). A p value < 0.05 was taken as a statistically significant difference between two groups.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 250 and 500 mg/kg/day significant decreased in body weight gain were observed as compare to control. 17 β-estradiol with BHA 500 mg/kg/day: Significant decreased were observed as compare to control in female rat.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No change was observed in Estradiol level of treated rat
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute and Relative Uterine weight was significantly decreased in 50, 100,250 and 500 mg/kg/day dose group. 17 β-estradiol with BHA 500 mg/kg/day: Significant decreased were observed in relative liver weight as compare to control
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No effect was observed in Uterine epithelial cell height of trested female rat as compare to control Also,BHA 50 or 500 mg/kg/day did not affect on 17β-estradiol induced increase of uterine epithelial cell height
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Effect on body weight gain and organ weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Low observed adverse effect level (LOAEL) was considered to be 50 mg/kg/body weight/day when female rat were sub-cutaneously exposed to the test chemical.
- Executive summary:
In a repeated dose subcutaneous toxicity study, female Crj:CD (SD) rats were exposed to the test chemical by subcutaneous injection into dorsal surface, caudal to the nape of neck in the concentration of 0, 50, 100, 250 and 500 mg/kg/body weight/day. Toxic changes were observed as decrease in body weight gain of 250 and 500 mg/kg/day treated female rat. Changes were also observd in uterine weight of female rat at 50 mg/kg/day. Therefore, Low observed adverse effect level (LOAEL) is considered to be 50 mg/kg/body weight/day when female rats are exposed to the test chemical by subcutaneous injection for 3 days.
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