Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

The available data and available weight of evidence demonstrate that Hydrocarbons, C9 aromatics are highly unlikely to be carcinogenic and are not classifiable as carcinogens. However, Naphthalene is classified as a carcinogen Category 2 (H351) under Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Key value for chemical safety assessment

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the negative results from read across in vitro and in vivo genotoxicity assays, and weight of evidence from repeat dose toxicity studies, Hydrocarbons, C9, aromatics do not warrant classification as carcinogens under Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). However, Naphthalene, a constituent of Hydrocarbons, C9, aromatics is classified as a carcinogen Category 2 (H351) under Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Additional information

The available data and available weight of evidence demonstrate that Hydrocarbons, C9 aromatics are highly unlikely to be carcinogenic and are not classifiable as carcinogens.

 

C9 aromatics are not genotoxic and are not classifiable as mutagens based upon the results of reliable in vitro and in vivo studies. In bacterial reverse mutation studies, C9 aromatic was not mutagenic in the presence or absence of metabolic activation (See C9 Aromatics IUCLID section 7.6.1 and the same section in this IUCLID). This is concordant with the findings that high flash aromatic naphtha is also clearly not mutagenic, clastogenic or aneugenic in mammalian cells in vitro, and in rats in vivo as evidenced by:

 

(a) a negative mammalian gene mutation (HGPRT forward mutation specific locus) assay;

(b) negative chromosome aberration tests (Chinese Hamster Ovary Chromosomal Aberration Test, Chinese Hamster Ovary Sister Chromatid Exchange Assay); and

(c) an in vivo inhalation exposure bone marrow chromosomal aberration study in rats (C9 Aromatics IUCLID sections 7.6.1 and 7.6.2).

 

1. Huo JZ, Aldous S, Campbell K, Davies N. Distribution and metabolism of 1,2,4-trimethylbenzene (pseudocumene) in the rat. Xenobiotica1989;19:161-170.