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EC number: 200-889-7 | CAS number: 75-65-0
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24-hr application followed by 14-day observation period
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to generally accepted guidelines for acute dermal study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- , see principles of test method.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- , see principles of test method.
- Principles of method if other than guideline:
- Test parameters were similar to those outlined in EPA OPPTS 870.1200 and EU Method B.3. However, there was no information provided on environmental conditions in the test area, test material was applied to abraded skin only, and there was no information provided on method of test material application, i.e. occluded vs. non-occluded.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-methylpropan-2-ol
- EC Number:
- 200-889-7
- EC Name:
- 2-methylpropan-2-ol
- Cas Number:
- 75-65-0
- Molecular formula:
- C4H10O
- IUPAC Name:
- 2-methylpropan-2-ol
- Reference substance name:
- tertiary butyl alcohol
- IUPAC Name:
- tertiary butyl alcohol
- Details on test material:
- -Identity (according to report): t-butyl alcohol
-Purity: 99.9% per sponsor
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: Kuiper's Rabbit Ranch, Gary, Indiana
-Animals: 5/sex
-Age: young adult
-Quarantine period: 16 days
-Weight at study initiation: 2409-3400 grams
-Housing: individual hanging wire-mesh cages
-Diet: Purina® Certified Rabbit Chow® #5322
-Identification method: ear tag
-Method of Animal Distribution: computer-generated table of pseudo-random numbers
ENVIRONMENTAL CONDITIONS: no information
IN-LIFE DATES:
-Date of study initiation: 24 April 1981
-Date of study termination: 8 May 1981
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- A single dose was administered undiluted as received to each of ten animals. Application was to abraded skin for 24 hours.
- Duration of exposure:
- 24 hours
- Doses:
- 1 dose at 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 14 days
-Mortality/morbidity: daily
-Body weights: evaluated; no information on frequency of examination during the study period
-Observation of clinical signs: daily
-Evaluation of Dermal Irritation: both treated and untreated skin of each rabbit was evaluated and scored (range of 0-none to 3-marked) for erythema, edema, atonia, desquamation, coriaceousness, fissuring, eschar and exfoliation.
-Necropsy performed: yes on all animals
-Gross pathology exam: all animals
-Histopathology: treated and untreated skin was examined in each animal
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Effects observed included ataxia, prostration, ocular discharge and moderate skin irritation.
- Mortality:
- None of the rabbits died during the study period.
- Clinical signs:
- other: The major effects observed during the study period were ataxia in all animals and injected iris (both eyes) in 5 males and 4 females. One male rabbit also exhibited prostration. All of the rabbits appeared normal by Day 1 with the exception of one femal
- Gross pathology:
- There were no compound-related macroscopic changes observed during post mortem examination of animals sacrificed at the termination of the study.
- Other findings:
- Microscopically, dermal inflammatory cell infiltrate occurred in both treated and untreated skin of rabbits. However, in general, the severity and extent of these changes were comparatively less in the untreated skins. Trace or mild acanthosis and hyperkeratosis were seen in the treated skin of five rabbits (one male and four females), but not in any of the untreated skins examined. Mild dermal fibroplasia was observed in the treated skin of four rabbits (one male and three females), but was absent in any of the untreated skin examined.
All of the rabbits exhibited the following signs of dermal irritation: erythema, edema and desquamation ranging from very slight (score 0.5) to moderate (score 2.0-2.5), and fissuring ranging from very slight (score 0.5) to slight (score 1.0-1.5). Coriaceousness and atonia ranging from very slight (score 0.5) to slight (score 1.0-1.5) were observed in some animals.
Any other information on results incl. tables
Based upon the data obtained, the Minimum Lethal Dose (MLD) for tertiary butyl alcohol -99.9% was found to be greater than 2000 mg/kg bw when administered once dermally to albino rabbits for 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified for Acute Toxicity; classified as Category 3 for Specific Target Organ Toxicity – Single Exposure
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In an acute dermal toxicity test, no deaths were reported when a limit dose of 2000 mg/kg bw of undiluted tertiary butyl alcohol was applied to the abraded skin of male and female New Zealand rabbits for twenty-four hours. The only effects related to test substance administration were reversible central nervous system effects in all animals and injected iris in all males and four of five females.
Tertiary butyl alcohol was not acutely toxic by the dermal route in rabbits at a dose of 2000 mg/kg bw and is not classified for acute lethality by the dermal route under GHS. Based on clinical signs indicating reversible effects on the central nervous system, tertiary butyl alcohol is classified as Category 3 for classification and labeling under GHS for Specific Target Organ Toxicity – Single Exposure. - Executive summary:
Under the conditions of this study, the dermal LD50 of tertiary butyl alcohol in male and female New Zealand White rabbits was > 2000 mg/kg bw. Exposure to large dermal doses of tertiary butyl alcohol may cause transient, reversible CNS effects. Twenty-four hour contact with abraded skin also caused slight to moderate site of contact dermal irritation in all animals.
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