Registration Dossier
Registration Dossier
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EC number: 942-066-1 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
REACH allows the assessment of the cancerogenicity of a given chemical with the help of findings from studies with repeated administration and from genetic toxicity studies. This is in line with the idea that the information requirements under REACH are regarded as the evaluation of all available data which does not necessarily require data from specific studies.
The registered substance and the read-across substance Bis(2-propylheptyl) hexanedioate did not induce genetic toxicity in the bacterial reverse gene mutation assay. The read-across substance did not induce genetic toxicity in the in vitro micronucleus test in V79 cells and an in vivo mouse bone marrow micronucleus test. In addition the read-across substance Bis(2-propylheptyl) hexanedioate was tested in a 90 day repeated dose study (BASF SE 2015) and a prenatal develeopmental toxicity study (WIL 2015). None of these studies showed any concern regarding cancerogenic properties of the test or read-across substance and thereby indicating no concern for cancer development induced by the test substance. Thus, a cancerogenicity study is not necessary. This waiving argument is in line with the guidance document “Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance” (October 2015).
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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