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Registration Dossier
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EC number: 204-881-4 | CAS number: 128-37-0
- 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

Endpoint summary
Administrative data
Description of key information
Skin irritation: Key study: Patch Test according to Draize (1944). BHT caused very slightly skin irritation in 3/6 rabbits treated on the intact skin, and 1/6 rabbits treated on the abraded skin (Bomhard 1996).
Eye irritation: Key study: Draize test according to Draize and Kelly (1952). Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Patch Test according to Draize (1944)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- comparable to guideline study with acceptable restriction; short observation periode (up to 72 h)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: Patch Test according to Draize (1944)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: six rabbits were treated on the intact skin, six rabbits on the abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24, 72 h
- Number of animals:
- 6 per group
- Details on study design:
- see text field materials and methods
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24h and 72 h
- Score:
- >= 0.3 - <= 0.7
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72 h, but a clear time dependent decrease was seen down to 0.3 within 72 h
- Remarks on result:
- other: very slight erythema (barley perceptible)
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- other: 24 h and 72 h
- Score:
- 0 - <= 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: very slight edema (barely perceptible)
- Irritant / corrosive response data:
- see text field results
- Other effects:
- see text field results
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- BHT caused very slightly skin irritation in 3/6 rabbits treated on the intact skin, and 1/6 rabbits treated on the abraded skin (Bomhard 1996).
- Executive summary:
BHT caused very slightly skin irritation in 3/6 rabbits treated on the intact skin, and 1/6 rabbits treated on the abraded skin (Bomhard 1996).
Reference
After semi-occlusive application of test substance to the
intact and scarified skin, respectively, a very slight
irritation could be noted: Intact skin: erythema 3/6 (24 h);
2/6 (72 h), edema 1/6 (24 h); 0/6 (72 h); abraded skin:
erythema 1/6 (24 h); 0/6 (72 h), edema 1/6 (24 h); 0/6 (72
h)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Draize test according to Draize and Kelly (1952)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with acceptable restrictions; short observation periode (up to 72 h).
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Method: other: Draize test according to Draize and Kelly (1952), Drug Cosmet. Industr. 71, 36 and FDA (1963), Fed. Reg. 28, 119, 5582
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
Amount applied: 100 other: mg - Duration of treatment / exposure:
- whole observation period
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- see text field materials and methods
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no ulceration or opacity
- Remarks on result:
- other: no ulceration or opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: fully reversible
- Irritant / corrosive response data:
- see text field results
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
- Executive summary:
Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
Reference
6 of 6 rabbits showed slight conjunctivitis after 24 hours.
Symptoms were completely reversible after 72 hours.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data, the substance is not classified as skin irritant or eye irritant.
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