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Diss Factsheets
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EC number: 202-653-9 | CAS number: 98-29-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Unspecified (results initially published in 2000)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-tert-butylpyrocatechol
- EC Number:
- 202-653-9
- EC Name:
- 4-tert-butylpyrocatechol
- Cas Number:
- 98-29-3
- Molecular formula:
- C10H14O2
- IUPAC Name:
- 4-tert-butylbenzene-1,2-diol
- Details on test material:
- - Radioactive labeling: 14-C on the methine carbon
- Radiolabeled compound specific activity: 15.0 mCi/mmol
- Radiochemical purity: approximately 94% (determined by HPLC)
- Radiolabeled batch number: 940207
- Radiolabeled compound provider: Wizard Laboratories (West Sacramento, CA)
- Non-radiolabeled batch number: DF04501LZ
- Non-radiolabeled compound provider: Aldrich Chemical Company, Inc. (Milwaukee, WI)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [14C]-p-tert-butylcatechol
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Raleigh, NC, and Portage, MI)
- Age at study initiation: 9 to 10 weeks old
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: Polycarbonate cages
- Individual metabolism cages: yes (from the day before dosing)
- Diet: Purina Rodent Chow No. 5002
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
Not specified
IN-LIFE DATES: Not specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: acetone
- Details on exposure:
- TEST SITE
- Area of exposure: 1 cm²
- % coverage: Not specified
- Type of wrap if used: metal tissue capsule glued over the dosing site with QuicktiteTM Super Glue Gel
- Time intervals for shavings or clipplings: Clipping approx. 24 hours before dose application
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: up to 72 hours after dosing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 to 22.2 μCi [14C]-radiolabel and appropriate amount of unlabeled p-tert-butylcatechol
- concentration (if solution): Not applicable
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not specified
- Amount(s) applied (volume or weight with unit): approximately 25 μL
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not specified
- Purity: Not specified
USE OF RESTRAINERS FOR PREVENTING INGESTION: No data - Duration and frequency of treatment / exposure:
- single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.04 or 4 mg/animal
- No. of animals per sex per dose / concentration:
- 4 males
- Control animals:
- no
- Details on study design:
- - Dose selection rationale: dermal doses for mice selected to provide approximately equal concentrations of p-tert-butylcatechol per square centimeter of skin as the 0.6 and 60 mg/kg doses administered to rats.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces.
- Time and frequency of sampling: once after 72h. Radioactivity was measured in urine collected 6, 24, 48 and 72h after dosing and feces collected 24, 48 and 72h after dosing (stored in dark at -20°C until analysis). Skin wash and digests of the application site skin and carcass were analysed by LSS.
METABOLITE CHARACTERISATION STUDY: no.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Most of the dose was absorbed by 72 hours following application (72% for the 0.04 mg dose and 86% for the 4 mg dose).
Mice applied 4 mg showed signs of local inflammation at the site of application. - Details on distribution in tissues:
- Global distribution of radioactivity in tissues, at the application site, in urine and feces (% of dose) is detailed below.
- Details on excretion:
- Cumulative excretion of radioactivity is detailed below.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Cumulative excretion of radioactivity (cumulative % of dose, mean +/- standard deviation):
Dose (mg) | Time (h) | Urine (%) | Feces (%) | Total (%) |
0.04 | 6 | 4.3 +/- 5.2 | - (not collected) | 4.3 +/- 5.2 |
24 | 32.1 +/- 9.6 | 7.45 +/- 5.39 | 39.6 +/- 13.6 | |
48 | 47.1 +/- 10.7 | 8.15 +/- 5.31 | 55.2 +/- 15.3 | |
72 | 51.7 +/- 8.9 | 12.4 +/- 7.7 | 64.1 +/- 15.7 | |
4 | 6 | 11.9 +/- 14.0 | - (not collected) | 11.9 +/- 14.0 |
24 | 54.3 +/- 10.5 | 2.58 +/- 1.30 | 56.9 +/- 10.3 | |
48 | 68.3 +/- 3.9 | 3.48 +/- 1.51 | 71.8 +/- 3.0 | |
72 | 71.4 +/- 3.5 | 5.42 +/- 2.55 | 76.8 +/- 1.4 |
Distribution of radioactivity at 72 hours (% of dose, mean +/- standard deviation):
Dose (mg/kg) | Tissues (%) | Application site (%) | Feces (%) | Urine (%) | Total absorbed dose (%) | Total unabsorbed dose (%) |
0.04 | 11.6 +/- 8.3 | 1.51 +/- 0.43 | 12.4 +/- 7.7 | 57.0 +/- 7.5 | 72.2 +/- 14.2 | 11.6 +/- 8.3 |
4 | 0.76 +/- 0.30 | 6.18 +/- 0.52 | 5.4 +/- 2.6 | 73.7 +/- 3.2 | 86.0 +/- 2.7 | 2.25 +/- 0.81 |
Applicant's summary and conclusion
- Conclusions:
- Bioaccumulation potential cannot be judged based on study results
The absorption, distribution and excretion of 4-tert butylpyrocatechol were studied in mice following a single dermal application of radiolabeled compound. - Executive summary:
Groups of 4 mice were administered a single dermal application of 0.04 or 4 mg/kg 14C-4-tert butylpyrocatechol (TBC).
At 72 hours following application, the total unabsorbed dose was 11.6% or 2.25% from total radioactivity, at 0.04 or 4 mg, respectively.
Most of the excreted radioactivity was retrieved from urine (up to 73.7%).
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.
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