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Toxicological information

Carcinogenicity

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Description of key information

Results  of mouse skin painting tests and initiation/promotion assays, together with modified Ames tests, and chemical (PAH) analysis indicate that Heavy Fuel Oil Components, particularly those containing cracked material, are carcinogenic.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
1
Study duration:
chronic
Species:
mouse
Quality of whole database:
Clear, significant increase in histologically diagnosed malignant skin tumours following lifetime treatment with 1% Catalytic Cracked Clarified Oil in toluene.

Additional information

Results from mouse skin painting studies demonstrate that cracked Heavy Fuel Oil Components are clearly carcinogenic.

The dermal carcinogenicity of catalytic cracked clarified oil (0.1%, 1% or 10% in toluene; CAS# 64741 -62 -4) was tested in a key non-guideline GLP-compliant lifetime mouse skin painting study (API, 1989a). The test solutions (50 uL) were applied twice weekly to an area of clipped skin on the dorsum, and the test included appropriate negative (sham, vehicle) and positive (0.01%, 0.05% benzo(a)pyrene) controls. Treatment was for the lifetime of the animals. The test substance elicited skin irritation that was similar in extent and incidence to that seen in the vehicle controls, with an increased incidence of malignant tumours with decreased latency present in the intermediate and high dose groups. A satisfactory response was obtained for the positive controls. The report concluded that catalytic cracked clarified oil was a strong dermal carcinogen.

Results from three skin painting studies on catalytic cracked clarified oil (CAS#64741 -62 -4) demonstrate a clear increase in incidence of malignant tumours (carcinomas) with decreased latency. Concentrations of 5% of the test substance in white oil produced tumors in most of the treated mice,

indicating that catalytic cracked clarified oil is a strong dermal carcinogen (McKee, 1990). Additionally, one study (Bingham, 1980) demonstrated that the uncracked base stock was not carcinogenic whilst the cracked base stock was weakly carcinogenic and all blends containing catalytically cracked clarified oil were carcinogenic in mice.

A single initiation/promotion assay also demonstrated that catalytically cracked clarified oil (CAS# 64741 -62 -4) is an initiator (API, 1989b).

Overall it can be concluded that both Straight-run and Cracked Heavy Fuel Oil Components are carcinogenic.

Justification for selection of carcinogenicity via dermal route endpoint:

One of 4 available studies.

Carcinogenicity: via dermal route (target organ): other: skin

Justification for classification or non-classification

Positive results in mouse skin painting studies and an initiation/promotion assay, together with supporting modified Ames data and

chemical (PAH) analysis show Cracked Heavy Fuel Oils Components are carcinogenic.

Classification Carcinogenic 1B, H350 is appropriate under the EU CLP Regulation (EC No. 1272/2008).