Registration Dossier

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

The available data and available weight of evidence demonstrate that isoeicosane is highly unlikely to be carcinogenic and is not classifiable as a carcinogen.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

These findings do not warrant the classification of isoeicosane as a carcinogen under the CLP Regulation (EC) 1272/2008 on classification, labeling and packaging of substances

Additional information

The weight of evidence is derived from read across study records reported for structural analogues isohexadecane, Hydrocarbons, C12 -C16, n-alkanes, isoalkanes, cyclics, <2% aromatics and hydrodesulfurized kerosene kerosene

Isoeicosane is not genotoxic and is not classifiable as a mutagen based upon the results of reliable in vitro and in vivo read across studies.

In a bacterial reverse mutation study, structural analogue isohexadecane was not mutagenic in the presence or absence of metabolic activation. In

mammalian cells in vitro, and in rats in vivo there were no mutagenic, clastogenic or aneugenic effects reported in read-across from studies on

Hydrocarbons, C12 -C16, n-alkanes, isoalkanes, cyclics, <2% aromatics and hydrodesulfurized kerosene kerosene, respectively.

Moreover, C14-20 Aliphatics (≤2% aromatic) hydrocarbon fluids are poorly absorbed if ingested. They undergo metabolism, rapid excretion and low deposition; bioaccumulation of the test substance in the tissues is not likely to occur. In addition, in repeat dose studies at levels up to 5000 mg/Kg/day, there were no cumulative effects and no evidence of hyperplasia.