Registration Dossier

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

There are no specific carcinogenicity data on any of the streams within this category. However, there are substantial data on the carcinogenicity of

a number of specific components present in some streams. Of these, benzene has been shown to be carcinogenic. Resin Oils and Cyclic Dienes are considered to be carcinogens if they contain ≥0.1% benzene or ≥1% naphthalene.

Key value for chemical safety assessment

Justification for classification or non-classification

Resin Oils and Cyclic Dienes that contain ≤0.1% benzene and ≤1% naphthalene are considered not to be carcinogenic and no classification is required under Reg (EC) 1272/2008.

The streams CAS numbers: 101316-62-5, 102110-15-6, 65996-79-4, 68477-50-9, 68477-54-3, and 68516-20-1 are listed in Annex VI of CLP and are classified as follows Carcinogenic Cat 1B, H350 under CLP Reg (EC) 1272/2008.

For other Resin Oils and Cyclic Dienes streams classification with respect to carcinogenicity is dependent upon the concentration of benzene and naphthalene as detailed below:

≥0.1% benzene: Carcinogenic Cat 1A, H350 “May cause cancer” under Reg (EC) 1272/2008.

<0.1% benzene: Carcinogenic Cat 1B, H350 “May cause cancer” under Reg (EC) 1272/2008.

<0.1% benzene and ≥1% naphthalene: Carcinogenic Cat 2, H351 under Reg (EC) 1272/2008 “Suspected of causing cancer”.

Additional information

There is no carcinogenicity information on any of the streams identified for this category. Specific components which have been identified as present in some streams and shown to be carcinogenic in animals and man are benzene and naphthalene:

 

Benzene (Classification: GHS/CLP - Category 1A, H350): Long term experimental carcinogenicity bioassays have shown that benzene is a carcinogen producing a variety of tumours in animals (including lymphomas and leukaemia). Human epidemiological studies indicate a causal relationship between benzene exposure and acute non-lymphatic leukaemia (Crump, 1994; Glass et al, 2003, 2004, 2006; Rinsky et al, 2002; Schnatter, 2004; 2012).

 

Naphthalene (Classification: GHS/CLP - Category 2, H352): According to the EU RAR (EU, 2003b) the limited information available in humans are considered insufficient conclude on carcinogenicity. However, naphthalene produced an increase in the incidence of respiratory epithelial adenomas and olfactory epithelial neuroblastomas (at the lowest exposure concentration of 10 ppm (50 mg/m3) in rats and an increase in the incidence of benign lung tumours (alveolar/bronchiolar adenomas) in mice. The tumours are considered to arise via a non-genotoxic mechanism and there is some uncertainty surrounding the relevance for human health. The LOAEL for carcinogenicity was considered to be 5 mg/m3.

 

References

 

EU (2003b). European Union Risk Assessment Report: Naphthalene. http: //ecb. jrc. ec. europa. eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/naphthalenereport020. pdf