Registration Dossier
Registration Dossier
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EC number: 265-052-0 | CAS number: 64741-51-1 A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
Carcinogenicity
Administrative data
Description of key information
One key (OECD 453) carcinogenicity study was identified that evaluated multiple unrefined/acid treated oils. Of the 94 oils tested in mice, there were 3 unrefined paraffinic distillates and 3 unrefined naphthenic distillates. All of these unrefined oils were carcinogenic. A number of other supporting studies also gave positive results
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
- Study duration:
- chronic
- Species:
- mouse
Justification for classification or non-classification
Based on the study results, and the EU harmonised classification, unrefined/acid treated oils are classified as Carcinogenic Category 1A (H350), according to the EU CLP Regulation (EC No.1272/2008).
Additional information
Chasey and McKee (1993) evaluated ninety-four oils in the mouse epidermal cancer bioassay in order to understand the effects of various types of refining processes on carcinogenic potential. These studies were conducted over a 15 year period. In these studies, male C3H mice, about 6-10 weeks of age, were obtained from either Jackson Laboratories (C3H/HeJ) or Charles River Laboratories (C3H / HeNCrlBR). These mice were randomly distributed into test groups of 40 or 50 animals. In early studies, mice were housed five per cage in suspended wire-mesh cages. In later studies, they were housed singly, in the same type of cages. The hair in the interscapular area was clipped once weekly to facilitate test material application. The test materials were applied by automatic pipette in either 37.5 microlitre aliquots twice a week or 25 microlitre aliquots three times a week. In early studies, treatment continued until the animals died spontaneously or were sacrificed in a moribund state. In later studies, surviving mice were sacrificed either after 24 months of treatment or at the time at which grossly diagnosed squamous cell carcinomas developed. Animals were examined twice weekly for the appearance of dermal tumours. Each tumour in the treatment area was examined carefully and classified grossly. All grossly diagnosed tumours were examined microscopically after study termination. Of the 94 oils tested, there were 3 unrefined paraffinic distillates and 3 unrefined naphthenic distillates. All of these unrefined oils were carcinogenic.
Additional data supports that unrefined/acid treated oils should be classified as Carcinogenic, Category 1A, H350 (API, 1989; Horton and Denman, 1955;). This information is presented in the dossier.
Justification for selection of carcinogenicity via dermal route endpoint:
One of a large number of repeat dose skin painting studies in mice with unrefined or poorly refined mineral oils. All samples tested were considered dermal carcinogens
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