Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-314-6 | CAS number: 2409-55-4
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.
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.
