Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Information is available from several GLP-compliant studies that have investigated the sensitisation potential of Heavy Fuel Oil Components in the guinea pig using a closed patch technique (Buehler method).

Skin sensitising potential was investigated in a key study in guinea pigs using the closed patch test procedure (API, 1980b). Ten adult male albino guinea pigs were each treated with 0.5 mL of the test material, three times per week for three weeks. The patches were left in place for 6 hours before removal. Two weeks after final application, they were challenged with 0.5 mL of test material. Scores were taken at 24 hours according to the Draize scale. A naive control group of 10 animals and a positive control group of 10 animals were also included. The naive control group was treated with test substance in the challenge phase only. The positive control group was treated with a 0.05% (w/v) dilution of dinitrochlorobenzene in both the sensitizing and challenge phases.

 

A statistically significant difference between sensitizing and challenge treatments for erythema and oedema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non-sensitizing. Based on results of the dermal challenge procedure, the test material was not considered to be a skin sensitiser.

Data are also available from multiple supporting studies (ARCO, 1992v-aa; 1990h,i; 1989j-l; 1988b; 1986h,i, and API, 1982a; 1980a,c,d) conducted in guinea pigs. Results obtained from these studies indicate no obvious potential for the induction or elicitation of dermal sensitisation, however skin irritation was apparent in a number of instances. A satisfactory response was obtained for the negative- and positive control groups.

The results indicate that Heavy Fuel Oil Components are not dermal sensitisers.

Migrated from Short description of key information:

Heavy Fuel Oil Components are not dermal sensitisers.

Justification for selection of skin sensitisation endpoint:

One of 18 available studies.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:

This endpoint is not a REACH requirement and no data are available for this endpoint but these substances are not expected to cause respiratory sensitisation.

Justification for classification or non-classification

Results from several GLP-compliant investigations using an induction methodology that met or exceeded the guideline requirements for skin sensitisation testing indicate that Heavy Fuel Oil Components are not dermal sensitisers in the guinea pig. This is consistent with knowledge of the chemistry present, which also indicates they are unlikely to cause respiratory sensitisation. No classification is required under the

EU CLP Regulation (EC No. 1272/2008).