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:

Multiple studies were available to assess the skin sensitising potential of other lubricant base oils. 

Sufficiently Refined Other Lubricant Base Oils (IP 346 < 3%)

In a key dermal sensitisation study (API, 1982a) 1.0 mL of test substance solvent dewaxed light paraffinic oil (CAS 64742-56-9, sufficiently refined, IP 346 < 3%) was applied to shaved skin of Hartley Albino guinea pigs under occlusive dressing once per week for three weeks with each exposure lasting 6 hours. The challenge dose (1.0 mL test material) occurred two weeks after the last induction dose. The challenge mean Draize scores were zero for erythema and oedema; therefore, solvent dewaxed light paraffinic oil was not considered to be a dermal sensitizer. 

 

In a study conducted with human volunteers (Exxon Biomedical Sciences, Inc. (1988d)), 112 human adults were dermally exposed to 0.2 mL of severely hydrotreated heavy naphthenic distillate (IP 346 < 3%) once a day, 4 days a week, for 13 exposures. A challenge phase was conducted where the participants were treated with 0.2 mL once a day, 4 days a week, for one week. The test substance was considered not sensitising due to the small number of slight or mild irritation responses recorded.  

 

Supporting data from studies conducted in guinea pigs (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984w, 1984x, 1984y; 1984z; 1984aa; 1984ab; 1984ac; 1984ad; 1984ae; 1984af; 1984ag; 1984ah; and Trimmer et al. 1989) and human volunteers (Exxon Biomedical Sciences, Inc., 1988e; 1988f; 1988g) demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are not dermal sensitizers.

Insufficiently Refined Other Lubricant Base Oils (IP 346 3%)

In a key dermal sensitisation study (API, 1986a), a 50% mixture of test substance hydrotreated light naphthenic oil (CAS 64742-53-6, insufficiently refined, IP 346 3%) with paraffin oil was applied to Hartley Albino guinea pigs under occlusive dressing during an induction phase of three weekly applications, each with a 6-hour exposure.  A challenge dose (1% test substance in paraffin oil) on a naïve site was given two weeks after the third induction application. Only one animal exhibited slight erythema during the challenge phase; therefore, the test substance was considered not sensitising.

Insufficiently refined other lubricant base oils (IP 346 3%) are not considered to be dermal sensitizers.

Migrated from Short description of key information:

Two key studies were identified for skin sensitisation, and the studies indicate that other lubricant base oils (sufficiently refined and insufficiently refined) do not cause allergic contact dermatitis.

Justification for selection of skin sensitisation endpoint:

One of Twenty Two skin sensitisation studies.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

This endpoint is not a REACH requirement.

Justification for classification or non-classification

Other lubricant base oils (sufficiently refined and insufficiently refined) do not meet the criteria for classification as dermal sensitizers under Annex VI of the EU CLP Regulation (EC No. 1272/2008).