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Carcinogenicity

Description of key information

Long term experimental carcinogenicity bioassays have shown that benzene, a constituent of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich), is a carcinogen producing a variety of tumours in animals (including lymphomas and leukaemia).

Human epidemiological studies indicate that benzene levels of ≥10 ppm are associated with increased risk of acute myeloid leukaemia (AML). 

The mode of action (MOA) for AML development leading to mortality is anticipated to include multiple earlier key events, which can be observed in hematotoxicity and genetic toxicity in peripheral blood of exposed workers. Prevention of such initial events would lead to prevention of the key, adverse outcomes, the morbidity and mortality caused by the myelodysplastic syndrome (MDS) and AML. The leukemic risk modelling analysis by North et al., 2020b supports the conclusion that cancer risk is not expected at an OEL of 0.25 ppm, which was proposed by Schnatter et al 2020.

There are no specific carcinogenicity data on other constituents of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich).

Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) is considered to be a carcinogen due to the high benzene content.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEL

25 mg/kg bw/day

Study duration:

chronic

Species:

rat

Quality of whole database:

Adequate information is available on the constituents to characterise the carcinogenic potential of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich).

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEC

960 mg/m³

Study duration:

chronic

Species:

mouse

Quality of whole database:

Adequate information is available on the constituents to characterise the carcinogenic potential of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich).

Carcinogenicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Since Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) contains ≥0.1% benzene, it should be classified as Carcinogenic Cat 1A, H350 “May cause cancer” under Reg (EC) 1272/2008.

Additional information

Benzene is a specific constituent of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) (ca. 15% (w/w)) and has been identified as a known human carcinogen. 

 

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).

Due to the benzene content of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich), which is approximately 15% w/w, Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) is considered to be carcinogenic, and is classified as a Carcinogen Category 1A (H350), in alignment with benzene.