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Diss Factsheets
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EC number: 217-752-2 | CAS number: 1948-33-0
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Repeated dose dermal toxicity study of the test chemical
- Author:
- EASTMAN KODAK CO
- Year:
- 1 989
- Bibliographic source:
- EASTMAN KODAK CO
- Reference Type:
- other: Authoritative data base
- Title:
- HSDB Number : 838
- Author:
- HSDB database
- Year:
- 2 011
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC:EASTMAN KODAK CO; Potential of Mono-t-butyl Hydroquinone to Produce Skin Depigmentation with Cover Letter Dated 05/04/89; 04/25/89;
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Effect of the test chemical was studied using guinea pigs
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-tert-butylhydroquinone
- EC Number:
- 217-752-2
- EC Name:
- 2-tert-butylhydroquinone
- Cas Number:
- 1948-33-0
- Molecular formula:
- C10-H14-O2
- IUPAC Name:
- 2-tert-butylbenzene-1,4-diol
- Details on test material:
- - Name of test material: tert-Butyl hydroquinone (TBHQ)
- IUPAC name: 2-tert-Butylhydroquinone
- Molecular formula: C10H14O2
- Molecular weight: 166.219 g/mol
- Substance type: Organic
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Outbred black guinea pigs were used
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: hydrophilic ointment
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1, 1.0, and 5.0% in 1 ml
Basis:
no data
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
Groups of five males and five females were dosed with 2-tert-butylhydroquinone or the vehicle (hydrophilic ointment) daily (M-F) for 13 weeks. The application site was evaluated weekly for degree of pigmentation loss and irritation. Twenty-four hours after final application, sites were evaluated for depigmentation, irritation and hyperpigmentation. Subsequently, the application site was depilated and re-evaluated for the same endpoints- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- At 0.1% the test chemical produced weak irritant responses and did not produced depigmentation and at 1.0%, 20% of animals had spotty or uniform loss of pigment
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- dissolved
- Sex:
- male/female
- Basis for effect level:
- other: At 0.1%, the test substance produced weak irritant responses and did not produce depigmentation.
- Dose descriptor:
- LOAEL
- Effect level:
- 10 000 mg/kg bw/day
- Based on:
- dissolved
- Sex:
- male/female
- Basis for effect level:
- other: At 1.0%, 20% of animals had spotty or uniform loss of pigment.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the effects observed in the study at 0.1%, the test chemical produced weak irritant responses and did not produced depigmentation and at 1.0%, 20% of animals had spotty or uniform loss of pigment. The NOAEL and LOAEL was assessed to be 0.1% (1000 mg/kg) and 1% (10000 mg/kg) respectively.
- Executive summary:
The test chemical was tested at concentrations of 0.1, 1.0 and 5.0%. Groups of five males and five females of black guinea pigs were dosed with the test chemical or the vehicle (hydrophilic ointment) daily (M-F) for 13 weeks. The application site was evaluated weekly for degree of pigmentation loss and irritation. Twenty-four hours after final application, sites were evaluated for depigmentation, irritation and hyperpigmentation. Subsequently, the application site was depilated and re-evaluated for the same endpoints. Repetitive exposure to concentrations of 1.0% and 5.0% were slightly to moderately irritating, while 0.1% produced only weak irritant response. No irritant responses to hydrophilic ointment were observed.
0.1% produced depigmentation, while 20% of animals dosed with 1.0% had spotty or uniform loss of pigment at the site of treatment. Approximately 40% of animals dosed with 5% were depigmented at the treatment site at the final evaluation.The study showed that the test chemical causes depigmentation in black guinea pigs at concentrations of 1% or greater, but that a no-effect threshold for this endpoint exists at a concentration between 0.1 and 1.0%. Hence NOAEL was assessed to be 0.1% (1000 mg/kg) and LOAEL was assessed to be 1% (10000 mg/kg).
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