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EC number: 201-841-8 | CAS number: 88-58-4
- 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:
- 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2,5-di-tert-butylhydroquinone
- EC Number:
- 201-841-8
- EC Name:
- 2,5-di-tert-butylhydroquinone
- Cas Number:
- 88-58-4
- Molecular formula:
- C14H22O2
- IUPAC Name:
- 2,5-di-tert-butylhydroquinone
Constituent 1
- Specific details on test material used for the study:
- The test substance is identified as di-tert-butyl hydroquinone. The purity is 99.6%. The physical state/appearance of material is white solid. The expiry date of material is 01 march 2019. The substance can be stored at room temperature in the dark conditions.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHanTM :WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
- Doses:
- 300 and 50
- Details on study design:
- A total of five animals were therefore treated at a dose level of 50 mg/kg in the study and 1 for 300 mg/kg.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 50 - 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animal treated at a dose level of 300 mg/kg was killed for humane reasons, 1 day after dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project Licence. There were no deaths noted at a dose level of 50 mg/kg
- Clinical signs:
- other: Signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg were ataxia, hunched posture, lethargy, pilo-erection, ptosis, occasional body tremors, tiptoe gait, emaciation, pallor of the extremities, hypothermia and elevated tail.
- Gross pathology:
- Hemorrhagic non-glandular epithelium of the stomach was noted at necropsy of the animal treated at a dose level of 300 mg/kg. No abnormalities were noted at necropsy of animals treated at a dose level of 50 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 50 - 300 mg/kg body weight (Globally Harmonized Classification System — Category 3).
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. Following a sighting test at dose levels of 300 mg/kg and 50 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 50 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. The animal treated at a dose level of 300 mg/kg was killed for humane reasons, 1 day after dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project Licence. There were no deaths noted at a dose level of 50 mg/kg. Signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg were ataxia, hunched posture, lethargy, pilo-erection, ptosis, occasional body tremors, tiptoe gait, emaciation, pallor of the extremities, hypothermia and elevated tail. There were no signs of systemic toxicity noted at a dose level of 50 mg/kg.
Animals treated at a dose level of 50 mg/kg showed expected gains in body weight. In necropsy Hemorrhagic non-glandular epithelium of the stomach was noted at necropsy of the animal treated at a dose level of 300 mg/kg. No abnormalities were noted at necropsy of animals treated at a dose level of 50 mg/kg.The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 50 - 300 mg/kg body weight (Globally Harmonized Classification System — Category 3).
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