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Description of key information

Dermal sensitization studies in human volunteers are available. Sufficiently refined lubricant base oils (IP 346 <3%) were not found to be dermal sensitizers in these studies.

Additional information

Five studies (one key and four supporting) that evaluated the dermal sensitization potential of sufficiently refined lubricant base oils (IP 346 <3%) in human volunteers are available.

In a key primary dermal irritation and sensitization study (EMBSI, 1988c), 112 human adults were dermally exposed to 0.2 mL of Lubricant base oil (MRD-88 -289; CAS# 64742-52-5). The participants were treated with lubricant base oil (MRD-88 -289) once a day, four days a week, for 13 exposures. A challenge phase was conducted where the participants were treated with 0.2 mL once a day, four days a week, for one week. Participants were asked to report any change in dermal effects for two weeks after the end of the challenge week. Irritation was scored following The International Contact Research Group System (3) and the Product Investigations, Inc scoring method.

 

In this study, lubricant base oil (MRD 88 -289) was not a dermal sensitiser based on the small number of slight or mild irritation responses recorded.

Supporting data from other studies (EMBSI, 1998d; 1988e; 1988f; 1988g) indicates that sufficiently refined lubricant base oils (IP 346 <3%) are not dermal sensitizers.