Registration Dossier
Registration Dossier
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EC number: 224-506-8 | CAS number: 4390-04-9
Carcinogenicity
Administrative data
Description of key information
The available read across data and available weight of evidence demonstrate that Isohexadecane is highly unlikely to be carcinogenic and is not classifiable as a carcinogen. Further testing is not required under Annex XI, section 1.2.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
These findings do not warrant the classification of Isohexadecane as a carcinogen under the CLP Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures.
Additional information
Isohexadecane is not genotoxic and is not classifiable as a mutagen based upon the results of reliable read across in vitro and in vivo studies. In bacterial reverse mutation studies, Isohexadecane and structural analogue Hydrocarbons, C14-C17, n-alkanes, <2% aromatics were not mutagenic in the presence or absence of metabolic activation. In mammalian cells in vitro there were no mutagenic, clastogenic or aneugenic effects reported in read-across from studies on hydrodesulfurized kerosene kerosene: a negative chromosome aberration (Human Peripheral Lymphocyte Chromosomal Aberration Test, Chinese Hamster Ovary Sister Chromatid Exchange Assay).
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