Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

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

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).

Justification for classification or non-classification