A GHS-consistent approach to health hazard classification of petroleum substances, a class of UVCB substances.

The process streams refined from petroleum crude oil for use in petroleum products are among those designated by USEPA as UVCB substances (unknown or variable composition, complex reaction products and biological materials). They are identified on global chemical inventories with unique Chemical Abstract Services (CAS) numbers and names. The chemical complexity of most petroleum substances presents challenges when evaluating their hazards and can result in differing evaluations due to the varying level of hazardous constituents and differences in national chemical control regulations. Global efforts to harmonize the identification of chemical hazards are aimed at promoting the use of consistent hazard evaluation criteria. This paper discusses a systematic approach for the health hazard evaluation of petroleum substances using chemical categories and the United Nations (UN) Globally Harmonized System (GHS) of classification and labeling. Also described are historical efforts to characterize the hazard of these substances and how they led to the development of categories, the identification of potentially hazardous constituents which should be considered, and a summary of the toxicology of the major petroleum product groups. The use of these categories can increase the utility of existing data, provide better informed hazard evaluations, and reduce the amount of animal testing required.

[1]  A. Hoberman,et al.  Reproductive Toxicity Study of Clarified Slurry Oil in the Rat , 1995 .

[2]  Katy O Goyak,et al.  The Toxicological Effects of Heavy Fuel Oil Category Substances , 2014, International journal of toxicology.

[3]  Thomas F Parkerton,et al.  PETROTOX: An aquatic toxicity model for petroleum substances , 2012, Environmental toxicology and chemistry.

[4]  W. Stubblefield,et al.  Evaluation of the dermal carcinogenic potential of tar sands bitumen-derived liquids. , 1986, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[5]  I. Drummond Light Hydrocarbon Gases: A Narcotic, Asphyxiant, or Flammable Hazard? , 1993 .

[6]  D. Mattie,et al.  Developmental Toxicity of JP‐8 Jet Fuel in the Rat , 1996, Journal of applied toxicology : JAT.

[7]  C. Mackerer,et al.  SYSTEMIC TOXICITY OF DERMALLY APPLIED CRUDE OILS IN RATS , 1997 .

[8]  G. E. Cox,et al.  Systemic Toxicity From Subchronic Dermal Exposure, Chemical Characterization, and Dermal Penetration of Catalytically Cracked Clarified Slurry Oil , 1986, Toxicology and industrial health.

[9]  P. Newton,et al.  Developmental toxicity evaluation of unleaded gasoline vapor in the rat. , 2001, Reproductive toxicology.

[10]  R. H. Mckee,et al.  Toxicological Assessment of Heavy Straight Run Naphtha in a Repeated Dose/Reproductive Toxicity Screening Test , 2014, International journal of toxicology.

[11]  H. Macfarland,et al.  A Chronic Inhalation Study with Unleaded Gasoline Vapor , 1984 .

[12]  C. A. Halder,et al.  Two-year inhalation toxicity study of petroleum coke in rats and monkeys. , 1987, American journal of industrial medicine.

[13]  T. Hansen,et al.  24 Months Inhalation Carcinogenicity Study of Bitumen Fumes in Wistar (WU) Rats , 2007 .

[14]  Lisa D Burry,et al.  Toxicology and Environmental Health , 2004, Critical Care.

[15]  Katy O Goyak,et al.  Acute, Subchronic, and Developmental Toxicological Properties of Lubricating Oil Base Stocks , 2014, International journal of toxicology.

[16]  U. Tillmann,et al.  A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. , 1997, Regulatory toxicology and pharmacology : RTP.

[17]  J J Freeman,et al.  Evaluation of the genetic toxicity of middle distillate fuels , 1994, Environmental and molecular mutagenesis.

[18]  M. Feuston,et al.  Partially Vaporized Full Range Catalytic Reformed Naphtha: Subchronic and Developmental Toxicity Studies in Rats , 1996 .

[19]  Mark J Nicolich,et al.  The development of statistical models to determine the relationship between aromatic-ring class profile and repeat-dose and developmental toxicities of high-boiling petroleum substances. , 2013, Regulatory toxicology and pharmacology : RTP.

[20]  B J Simpson,et al.  A comprehensive evaluation of the mechanism of skin tumorigenesis by straight-run and cracked petroleum middle distillates. , 1998, Toxicological sciences : an official journal of the Society of Toxicology.

[21]  L. Griffis,et al.  Petroleum mineral oil refining and evaluation of cancer hazard. , 2003, Applied occupational and environmental hygiene.

[22]  T. R. Sterner,et al.  Reproductive Effects on JP-8 Jet Fuel on Male and Female Sprague-Dawley Rats after Exposure by Oral Gavage , 2000 .

[23]  J. J. Freeman,et al.  Asphalt fume dermal carcinogenicity potential: I. dermal carcinogenicity evaluation of asphalt (bitumen) fume condensates. , 2011, Regulatory toxicology and pharmacology : RTP.

[24]  E. J. Singer,et al.  Developmental Toxicity of Clarified Slurry Oil Applied Dermally to Rats , 1989, Toxicology and industrial health.

[25]  S. Khan,et al.  Embryotoxic evaluation of a Prudhoe Bay crude oil in rats. , 1987, Toxicology letters.

[26]  C. P. Carpenter,et al.  Petroleum hydrocarbon toxicity studies. I. Methodology. , 1975, Toxicology and applied pharmacology.

[27]  S. Cragg,et al.  Lack of concordance of the Salmonella/microsome assay with the mouse dermal carcinogenesis bioassay for complex petroleum hydrocarbon mixtures. , 1985, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[28]  R. Scala,et al.  Estimation of epidermal carcinogenic potency , 1990 .

[29]  Mark J Nicolich,et al.  Assessing the mammalian toxicity of high-boiling petroleum substances under the rubric of the HPV program. , 2013, Regulatory toxicology and pharmacology : RTP.

[30]  C. Mackerer,et al.  Estimation of the dermal carcinogenic activity of petroleum fractions using a modified Ames assay , 1984, Cell Biology and Toxicology.

[31]  Gary R. Blackburn,et al.  Predicting carcinogenicity of petroleum distillation fractions using a modified Salmonella mutagenicity assay , 1986, Cell Biology and Toxicology.

[32]  C. Schreiner,et al.  Toxicity Evaluation of Petroleum Blending Streams: Inhalation Subchronic Toxicity/Neurotoxicity Study of a Light Catalytic Cracked Naphtha Distillate in Rats , 2001, International journal of toxicology.

[33]  Sunanda Kadam,et al.  Globally Harmonized System of Classification and Labeling of Chemicals , 2010 .

[34]  C. Mackerer,et al.  Correlation of Systemic and Developmental Toxicities with Chemical Component Classes of Refinery Streams , 1994 .

[35]  C. Mackerer,et al.  Developmental toxicity of dermally applied crude oils in rats. , 1997, Journal of toxicology and environmental health.

[36]  Worth Andrew,et al.  A Compendium of Case Studies that Helped to Shape the REACH Guidance on Chemical Categories and Read Across , 2007 .

[37]  R. H. Mckee,et al.  Assessment in rats of the reproductive toxicity of gasoline from a gasoline vapor recovery unit. , 2000, Reproductive toxicology.

[38]  Steven J. Enoch,et al.  Chemical Category Formation and Read-Across for the Prediction of Toxicity , 2010 .

[39]  Motor gasoline toxicity. , 1988, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[40]  H. Enoch,et al.  Comparative study of the genotoxic properties of Eastern and Western U.S. shale oils, crude petroleum, and coal-derived oil. , 1982, Mutation research.

[41]  Mark J Nicolich,et al.  The relationship between developmental toxicity and aromatic-ring class profile of high-boiling petroleum substances. , 2013, Regulatory toxicology and pharmacology : RTP.

[42]  P. Lees Chapter 4 – Toxicology and pharmacology , 2006 .

[43]  Katy O Goyak,et al.  Characterization of the Noncancer Hazards of Gas Oils , 2014, International journal of toxicology.

[44]  T. Hansen,et al.  Evaluation of reproductive/developmental and repeated dose (subchronic) toxicity and cytogenetic effects in rats of a roofing asphalt fume condensate by nose-only inhalation. , 2011, Regulatory toxicology and pharmacology : RTP.

[45]  C. Mackerer,et al.  Developmental toxicity of clarified slurry oil, syntower bottoms, and distillate aromatic extract administered as a single oral dose to pregnant rats. , 1996, Journal of toxicology and environmental health.

[46]  A. Hoberman,et al.  Developmental toxicity study of clarified slurry oil (CSO) in the rat. , 1995, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[47]  F. Leighton The systemic toxicity of Prudhoe Bay crude and other petroleum oils to CD-1 mice , 1990, Archives of environmental contamination and toxicology.

[48]  R. H. Mckee,et al.  Toxicological Assessment of Green Petroleum Coke , 2014, International journal of toxicology.

[49]  R. H. Mckee,et al.  Evaluation of the dermal carcinogenicity of lubricant base oils by the mouse skin painting bioassay and other proposed methods , 1993, Journal of applied toxicology : JAT.

[50]  J. J. Freeman,et al.  Asphalt fume dermal carcinogenicity potential: II. Initiation-promotion assay of Type III built-up roofing asphalt. , 2011, Regulatory toxicology and pharmacology : RTP.

[51]  C R Clark,et al.  Comparative Dermal Carcinogenesis of Shale and Petroleum-Derived Distillates , 1988, Toxicology and industrial health.

[52]  R. H. Mckee,et al.  The Toxicological Properties of Petroleum Gases , 2014, International journal of toxicology.

[53]  J J Freeman,et al.  The role of dermal irritation in the skin tumor promoting activity of petroleum middle distillates. , 1999, Toxicological sciences : an official journal of the Society of Toxicology.

[54]  C. Mackerer,et al.  Developmental toxicity study in rats exposed dermally to clarified slurry oil for a limited period of gestation. , 1996, Journal of toxicology and environmental health.