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EC number: 219-314-6 | CAS number: 2409-55-4
- 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
Carcinogenicity
Administrative data
Description of key information
the tumor-promoting potential of 2-tert-butyl-p-cresol was evaluated on rats and guinea pigs which were applicated the test substance in diet alone or following the application of an initiator.
In hamsters the test substance strongly induced hyperplasia and tumor lesions in the forestomach. No histopathological lesions were observed in the urinary bladder epithelium.
In rats mammary tumor development was reduced by diet containing 2 -tert-butyl-p-cresol after pretreatment with 7.12-dimethylaminobenz[a]anthracene. The incidence of ear duct tumors was not affected. Development of forestomach tumors was not significantly enhanced.
In a further study 6 out of 15 rats treated with 2 -tert-butyl-p-cresol alone, 6 rats had a hyperplasia and none of the rats revealed papilloma, carcinoma in situ or squamous cell carcinoma.
In the fundic and pyloric region of the glandular stomach none out of 15 rats treated with 2 -tert-butyl-p-cresol revealed a lesion.
From these results the incidence of Cancerogenicity of 2 -tert-butyl-p-cresol is only elevated in combination with MNNG ((N-methyl-N'-nitro-N-nitrosoguanidine). The urinary bladder tumor-promoting potentials of 2-tert-butyl-p-cresol was also investigated. A significant increases in the incidences and average numbers of the putative preneoplastic lesions, papillary or nodular (PN) hyperplasia, and papillomas of the urinary bladder were only observed in the group given 2 -tert-butyl-p-cresol after BBN (N-butyl-N-(4-hydroxybutyl)nitrosamine).
Key value for chemical safety assessment
Justification for classification or non-classification
The available studies revealed no clear incidence for a cancerogenic potential of 2 -tert-butyl-p-cresol. A classification is therefore not justified
Additional information
The results of the not assignable rat studies revealed for 2 -tert-butyl-p-cresol only in combination of a pretreatment with an inittiator a carcinogenic potential. Given 2 -tert-butyl-p-cresol alone the results are negative or ambiguous. In hamsters tumorous lesions were found in the forestomach. 2-tert-butyl-p-cresol is corrosive - the assignability of the forestomach findings to humans is not clear. Because 2-tert-butyl-p-cresol shall be registrated according REACH Article 18 (transported isolated intermediate) only an Ames test in necessary according REACH Annex VII. Further testing is not justified on scientific and animal welfare grounds
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.
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