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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Although the study was not conducted according to the recommended guidelines, it provides scientific valid information to assess the subchronic effects of the substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Groups of 10 male mice and 10 female mice were treated with 0.1 ml of dimethylsulfoxide (DMSO) solutions containing 0, 5, 10, 20 or 30 mg of BHT topically applied 3 times weekly for 4 weeks. Pneumotoxicity was investigated.
Groups of 10 male rats and 10 female rats were treated 3 times weekly for 4 weeks with either 240 mg BHT in 0.6 ml of DMSO or 0.6 ml of DMSO alone and groups of 10 male hamsters were treated 3 times weekly with 480 mg of BHT in 1.2 ml of DMSO or 1.2 ml of DMSO alone. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): BHT
- purity: food aditive grade >98%
- Source: Wako Pure Chemical Co. Ltd., Osaka
Constituent 1
Test animals
- Species:
- other: mice, rats and hamsters
- Strain:
- other: CD-1 mice, F-344 rats and Syrian golden hamsters
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- DMSO
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 3 times weekly
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
Mice: 0, 5, 10, 20 or 30 mg BHT (0, 145, 289, 578 or 867 mg/kg in males and 0, 208, 415, 830 and 1245 mg/kg in females)
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
Rats: 0 or 240 mg BHT (0 or 1967 mg/kg in males and 0 or 2286 mg/kg in females)
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
Hamsters: 0 or 480 mg BHT (0 or 3097 mg/kg in males)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Lung damage was noted in CD-1 mice dermally treated with BHT (males: 145-867 mg/kg bw/day; females: 208-1245 mg/kg bw/day) for four weeks. Similar treatment of F 344 rats (ca. 2000 mg/kg bw/day) and of hamsters (ca. 3100 mg/kg bw/day) was tolerated without adverse effects other than a slight growth retardation. These data suggest that reactive metabolites rather than the parent compound are responsible for the lung damage. Variation in metabolic pathways involved in production of reactive intermediates could provide a basis for the observed nonreactive individual animal, species and sex difference in the pneumotoxicity of BHT.
- Executive summary:
Groups of 10 male mice and 10 female mice were treated with 0.1 ml of dimethylsulfoxide (DMSO) solutions containing 0, 5, 10, 20 or 30 mg of BHT topically applied 3 times weekly for 4 weeks. Pneumotoxicity was investigated. Groups of 10 male rats and 10 female rats were also treated 3 times weekly for 4 weeks with either 240 mg BHT in 0.6 ml of DMSO or 0.6 ml of DMSO alone and groups of 10 male hamsters were treated 3 times weekly with 480 mg of BHT in 1.2 ml of DMSO or 1.2 ml of DMSO alone. Lung damage was noted in CD-1 mice dermally treated with BHT (males: 145-867 mg/kg bw/day; females: 208-1245 mg/kg bw/day) for four weeks. Between day 4 and 8 of the study dose-dependent respiratory distress with subsequent mortality was observed in all dose groups, except for males at 145 mg/kg bw/day. Autopsy revealed congestion and enlargement of the lung; histologically, degeneration and necrosis of the type I alveolar epithelial cells and an increased number of type II cells was found. The skin at the site of application showed epidermal hyperplasia. Other organs appeared normal in all dose groups. Similar treatment of F 344 rats (ca. 2000 mg/kg bw/day) and of hamsters (ca. 3100 mg/kg bw/day) was tolerated without adverse effects other than a slight growth retardation. These data suggest that reactive metabolites rather than the parent compound are responsible for the lung damage. Variation in metabolic pathways involved in production of reactive intermediates could provide a basis for the observed nonreactive individual animal, species and sex difference in the pneumotoxicity of BHT.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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