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EC number: 205-769-8 | CAS number: 150-76-5
- 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
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- Nanomaterial surface chemistry
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Full details are not available, but the general test conditions are acceptable for the assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- A study of the pharmacokinetics of 4-hydroxyanisole
- Author:
- Holden JL, Dewey DL, Riley PA
- Year:
- 1 984
- Bibliographic source:
- Hydroxyanisole: Recent Adv Anti-Melanoma Ther (1984), 213-220. Editor(s): Riley, PA. Publisher: IRL, Oxford, UK
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test substance in 0.9% saline were injected by intraperitoneal (ip.) and intraveinous (iv.) into the tail vein in a volume of 10 mL/kg bw, of male and female mice. The mice were treated with saline solution for control group. Blood samples were collected by cardiac puncture. Concentration of the TS in plasma is measured by high pressure liquid
chromatography.
Urines and faeces are collected 24 and 48 hours after administration of radiolabelled TS, and analysed by scintillation counting. - GLP compliance:
- no
Test material
- Reference substance name:
- 4-OHA (4-hydroxyanisole)
- IUPAC Name:
- 4-OHA (4-hydroxyanisole)
- Reference substance name:
- Mequinol
- EC Number:
- 205-769-8
- EC Name:
- Mequinol
- Cas Number:
- 150-76-5
- Molecular formula:
- C7H8O2
- IUPAC Name:
- 4-methoxyphenol
- Details on test material:
- Name of test material: 4-OHA (4-hydroxyanisole), supplied by Koch-Light Ltd
(Colnbrooks Bucks, England)
Substance type: data not available
physical state : data not available
Analytical purity: data not available
impurities: data not available
Composition of the test material: not applicable
Purity test date: data not available
lot/batch No: data not available
expiration date of the lot/batch: data not available
Radiolabelling: yes: 3H 4-OHA
radiochemical purity: data not available
specific activity: 100 µCi/mg
locations of the label: data not available
expiration data of radiochemical substance: data not available
stability under test conditions: data not available
storage condition of test material: data not available
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- 3H 4-OHA
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: mouse
- Strain: CBA
- Sex: male/female
- Source: Gray Laboratory of Cancer Research (UK)
- Age at study initiation: data not available
- Weight at study initiation: 30-35 g (males), 25 g (females)
- Fasting period before study: data not available
- Housing: data not available
- Individual metabolism cages: data not available
- Diet: data not available
- Water: data not available
- Acclimation period: data not available
ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod): data not available
IN-LIFE DATES: data not available
Administration / exposure
- Route of administration:
- other: i.p. and i.v.
- Vehicle:
- physiological saline
- Duration and frequency of treatment / exposure:
- single application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 25, 50, 100, 150, 200 mg/kg bw
Females: 25, 100, 150, 200, 300 mg/kg bw
(doses higher than 150 mg/kg bw by iv. administration were not studied, as they approach the acute LD50)
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- not specified
- Positive control reference chemical:
- no
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data - Details on dosing and sampling:
- - Tissues and body fluids sampled (delete / add / specify): urine, faeces, plasma
- Time and frequency of sampling: at 24 and 48h after administration (urine and faeces), 10 times up to 45 minutes (males) or 90 minutes (females)
(plasma concentration) - Statistics:
- no data
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 3rd:
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
ELIMINATION RATE:
* Male mice:
In the case of ip. injection, the plot of log10 plasma concentration vs time is linear at all dose levels.
When mice are given i.v. injection, the rate of elimination is linear at 25 and 50 mg/kg
bw, but at the higher doses the initial rate of
elimination decreases with dose.
* Female mice:
Above 25 mg/kg
bw the initial elimination rate decreases with increasing dose and the rate of elimination is not linear.
HALF-LIFE:
T(1/2) increases with increasing doses.
Dose (mg/kg bw) T(1/2) in minutes
iv. 25 3.9 +/- 0.23
iv. 150 5.9 +/- 0.3
ip. 25 5.1 +/- 0.52
ip. 150 7.8 +/- 0.66
TOXICOKINETICS PARAMETERS:
- Parameter: Half-life 1st:
AUC: Area under the plasma (blood) level vs. time curve from zero up to a certain measured time point (specify the time);
URINARY EXCRETION OF RADIO-LABEL
After ip. injection, free 4
OHA was not detected in either urine or faeces; 96.54% of the radioactivity was accounted for 48 hours.
86% was present in the urine.
% dose excreted after ip. injection of 200 mg/kg 1 µCi 3H 4-OHA into male CBA mice:
Time Urinary Faecal
(hrs) radioactivity radioactivity
24 81.3 +/- 19.6 6.2 +/- 0.15
48 4.7 +/- 1.8 4.2 +/- 2.8
Applicant's summary and conclusion
- Conclusions:
- No bioaccumulation potential based on study results
- Executive summary:
In a metabolism study, 4-hydroxyanisole was administered to CBA mice, in a single dose application by iv. or ip. administration:
males: 25, 50, 100, 150, 200 mg/kg bw
females: 25, 100, 150, 200, 300 mg/kg bw
The results concerning the effect of dose on the pharmacokinetics of 4-OHA indicate saturable non-linear behaviour at high doses in male and female mice. The female mice were younger than the males and no direct comparison can be made between the sexes. In the case of iv.
delivery of the substance to the male mice, non linear elimination was seen at 100 and 150 mg/kg bw. Clearance of 4-OHA is most probably by metabolism.
The results concerning excretion of radio label indicate that free 4-OHA is not detected in either urine or faeces; 96.54% of the radioactivity were accounted for by 48 hours: 86% were present in the urine.
The bioavailability of 4-OHA given by ip. injection was 104%. There was no significant difference between the half-life of the substance given by ip. and iv. administration.
The volume of distribution indicates that 4-OHA is distributed throughout the total body water, and intracellular concentrations would not be expected to vary greatly from gross measurments. This study has shown that 4-OHA is rapidly absorbed into the circulation.
This metabolism study in the mouse is classified acceptable and does not satisfy the guideline requirement for a metabolism study (OPPTS 870.7485); OECD 417 in mouse.
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