Registration Dossier

Administrative data

Description of key information

Heavy Fuel Oil Components are no more than moderately irritating to skin under occlusive dressing post 24-hours exposure (insufficient for classification), and non-irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The dermal irritation potential of Heavy Fuel Oil Components toward intact and abraded skin has been investigated in a large number of studies using open or occluded skin contact and exposure periods of 4 h or 24 h duration. In all instances dermal responses (erythema, oedema, dryness, cracking etc) were recorded using Draize criteria.

In a key dermal irritation study (API, 1980b), 0.5 mL of the test material was applied to the clipped skin of New Zealand White rabbits (3/sex) for 24 hours. The test material was applied to both abraded and non-abraded skin areas and covered with a closed patch (occlusive dressing). The animals were monitored over 72 hours post exposure and scored according to the Draize scale. Significant skin irritation was not observed following treatment.

Data from multiple supporting studies (ARCO, 1992o-s; 1990d,e; 1989d-f; 1987f; 1986d,e; Mobil, 1992c; 1988f-h; and API, 1980a,c,d) indicate a variable capacity to elicit skin irritation with no consistent difference in the relative intensity or relative persistence of skin reactions following 4 or 24 h contact, or exposure under occluded or open conditions. Hence although the conditions used in the majority of studies deviate from those of guideline recommendations, findings of erythema and oedema scores less than 2 in a majority of cases indicates that Heavy Fuel Oil Components are no more than moderately irritating to skin.

Eye Irritation

Information on the eye irritation potential of Heavy Fuel Oil Components is available from a large number of GLP-compliant studies that followed guideline recommendations. In all instances, neat test substance (0.1 mL) was instilled into the eye of 3-6 rabbits, the eyelids held shut for a few seconds before releasing, and ocular responses recorded using Draize criteria.

In a key eye irritation study (API, 1980b), six New Zealand White rabbits were treated with 0.1 mL of No 6 heavy fuel oil. An additional three animals were also treated with 0.1 mL of test substance, following which their eyes were rinsed with water. Effects on the eyes were monitored over 7 days with scoring according to the Draize scale. Corneal opacities of grade 1 and area 1 were seen in some animals at the 24 and 48-hour reading. No iridial inflammation was seen in any of the test animals. Conjunctival irritation was seen in all of the rabbits at 24 and 48 hours post dosing. All rabbits were negative for irritation after 7 days. The test substance was therefore considered to be mildly irritating.

Data from multiple supporting studies (ARCO, 1992t,u; 1991a-c; 1990f,g; 1989g-i; 1988a; 1986f,g; Mobil, 1992d; 1988i-k; and API 1982a; 1980a,c,d) indicate no more than mild or mild-moderate reversible irritation (mean intensity less than 2) of the rabbit eye, reflecting redness or swelling (chemosis) of the conjunctivae with mild corneal opacity or discharge occurring rarely. Overall, Heavy Fuel Oil Components appear to cause no more than transient, fully reversible eye irritation.

Justification for selection of skin irritation / corrosion endpoint:

One of 21 available studies.

Justification for selection of eye irritation endpoint:

One of 22 available studies.

Justification for classification or non-classification

The dermal irritation potential of samples of Heavy Fuel Oil Components has been tested in a large number of generally GLP-compliant rabbit skin irritation studies. The majority of data were derived using a 24 hr occluded exposure protocol. The conclusions of these studies indicate a potential to evoke no more than moderate skin irritation, with no evidence of injuries in depth (corrosion). The eye irritation potential of samples of Heavy Fuel Oil Components has been tested in a number of generally GLP-compliant near-guideline rabbit eye irritation studies. None of the samples tested elicited more than transient, fully reversible eye irritation. No classification is required under the EU CLP Regulation (EC No. 1272/2008).