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Selected refined base oils: Human health tier II assessment

04 July 2014

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Chemicals in this assessment

Chemical Name in the Inventory CAS Number
Distillates, petroleum, heavy hydrocracked 64741-76-0
Distillates, petroleum, solvent refined heavy paraffinic 64741-88-4
Distillates, petroleum, solvent refined light paraffinic 64741-89-5
Residual oils, petroleum, solvent deasphalted 64741-95-3
Distillates, petroleum, solvent refined heavy naphthenic 64741-96-4
Distillates, petroleum, solvent refined light naphthenic 64741-97-5
Residual oils, petroleum, solvent, refined 64742-01-4
Distillates, petroleum, clay treated heavy paraffinic 64742-36-5
Distillates, petroleum, clay treated light paraffinic 64742-37-6
Residual oils, petroleum, clay treated 64742-41-2
Distillates, petroleum, clay treated heavy naphthenic 64742-44-5
Distillates, petroleum, clay treated light naphthenic 64742-45-6
Lubricating oils, petroleum, clay treated spent 64742-50-3
Distillates, petroleum, hydrotreated heavy naphthenic 64742-52-5
Distillates, petroleum, hydrotreated light naphthenic 64742-53-6
Distillates, petroleum, hydrotreated heavy paraffinic 64742-54-7
Distillates, petroleum, hydrotreated light paraffinic 64742-55-8
Distillates, petroleum, solvent dewaxed light paraffinic 64742-56-9
Residual oils, petroleum, hydrotreated 64742-57-0
Lubricating oils, petroleum, hydrotreated spent 64742-58-1
Residual oils, petroleum, solvent, dewaxed 64742-62-7
Distillates, petroleum, solvent dewaxed heavy naphthenic 64742-63-8
Distillates, petroleum, solvent dewaxed light naphthenic 64742-64-9
Distillates, petroleum, solvent dewaxed heavy paraffinic 64742-65-0
Foots oil, petroleum 64742-67-2
Naphthenic oils, petroleum, catalytic dewaxed heavy 64742-68-3
Naphthenic oils, petroleum, catalytic dewaxed light 64742-69-4
Paraffin oils, petroleum, catalytic dewaxed heavy 64742-70-7
Paraffin oils, petroleum, catalytic dewaxed light 64742-71-8
Naphthenic oils, petroleum, complex dewaxed heavy 64742-75-2
Naphthenic oils, petroleum, complex dewaxed light 64742-76-3
Extracts, petroleum, heavy naphthenic distillate solvent, aromatic concentrate 68783-00-6
Extracts, petroleum, solvent refined heavy paraffinic distillate, solvent 68783-04-0
Extracts, petroleum, heavy paraffinic distillates, solvent deasphalted 68814-89-1
Hydrocarbons, hydrocracked paraffinic distillation residues, solvent dewaxed 93763-38-3
Lubricating oils, petroleum, C>25, hydrotreated bright stock based 72623-83-7
Lubricating oils, petroleum, C15-30, hydrotreated neutral oil based, containing solvent deasphalted residual oil 72623-84-8
Lubricating oils, petroleum, C20-50, hydrotreated neutral oil based, high viscosity 72623-85-9
Lubricating oils, petroleum, C15-30, hydrotreated neutral oil based 72623-86-0
Lubricating oils, petroleum, C20-50, hydrotreated neutral oil based 72623-87-1
Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated 90640-95-2
Distillates, petroleum, solvent dewaxed light paraffinic, clay treated 90640-96-3
Distillates, petroleum, solvent dewaxed light paraffinic, hydrotreated 90640-97-4
Extracts, petroleum, heavy paraffinic distillate solvent, hydrotreated 90641-08-0
Extracts, petroleum, light paraffinic distillate solvent, hydrotreated 90641-09-1
Distillates, petroleum, dewaxed heavy paraffinic, hydrotreated 91995-39-0
Distillates, petroleum, dewaxed light paraffinic, hydrotreated 91995-40-3
Distillates, petroleum, hydrocracked solvent refined, dewaxed 91995-45-8
Lubricating oils, petroleum, hydrocracked, nonaromatic, solvent deparaffined 92045-43-7
Distillates, petroleum, solvent refined hydrocracked light 94733-09-2
Lubricating oils, petroleum, C18-40, solvent dewaxed, hydrocracked, distillate based 94733-15-0
Distillates, petroleum, hydrocracked solvent refined light 97488-73-8
Lubricating oils, petroleum, C18-27, hydrocracked solvent dewaxed 97488-95-4

Preface

This assessment was carried out by staff of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) using the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework.

The IMAP framework addresses the human health and environmental impacts of previously unassessed industrial chemicals listed on the Australian Inventory of Chemical Substances (the Inventory).

The framework was developed with significant input from stakeholders and provides a more rapid, flexible and transparent approach for the assessment of chemicals listed on the Inventory.

Stage One of the implementation of this framework, which lasted four years from 1 July 2012, examined 3000 chemicals meeting characteristics identified by stakeholders as needing priority assessment. This included chemicals for which NICNAS already held exposure information, chemicals identified as a concern or for which regulatory action had been taken overseas, and chemicals detected in international studies analysing chemicals present in babies’ umbilical cord blood.

Stage Two of IMAP began in July 2016. We are continuing to assess chemicals on the Inventory, including chemicals identified as a concern for which action has been taken overseas and chemicals that can be rapidly identified and assessed by using Stage One information. We are also continuing to publish information for chemicals on the Inventory that pose a low risk to human health or the environment or both. This work provides efficiencies and enables us to identify higher risk chemicals requiring assessment.

The IMAP framework is a science and risk-based model designed to align the assessment effort with the human health and environmental impacts of chemicals. It has three tiers of assessment, with the assessment effort increasing with each tier. The Tier I assessment is a high throughput approach using tabulated electronic data. The Tier II assessment is an evaluation of risk on a substance-by-substance or chemical category-by-category basis. Tier III assessments are conducted to address specific concerns that could not be resolved during the Tier II assessment.

These assessments are carried out by staff employed by the Australian Government Department of Health and the Australian Government Department of the Environment and Energy. The human health and environment risk assessments are conducted and published separately, using information available at the time, and may be undertaken at different tiers.

This chemical or group of chemicals are being assessed at Tier II because the Tier I assessment indicated that it needed further investigation.

For more detail on this program please visit:www.nicnas.gov.au

Disclaimer

NICNAS has made every effort to assure the quality of information available in this report. However, before relying on it for a specific purpose, users should obtain advice relevant to their particular circumstances. This report has been prepared by NICNAS using a range of sources, including information from databases maintained by third parties, which include data supplied by industry. NICNAS has not verified and cannot guarantee the correctness of all information obtained from those databases. Reproduction or further distribution of this information may be subject to copyright protection. Use of this information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. NICNAS does not take any responsibility whatsoever for any copyright or other infringements that may be caused by using this information.

Grouping Rationale

The chemicals in this group are all refined distillate base oils derived from crude oil. These chemicals undergo a series of extractive or transforming processes that improve the base stocks' performance characteristics and remove or reduce undesirable components such as polyaromatic compounds (PACs).

The chemicals are complex mixtures of straight and branched-chain paraffinic, naphthenic and aromatic hydrocarbons having carbon numbers in the C15–C50 range. The chemical composition of these chemicals depends on both the original crude oil and on the refining process. The toxicity profile of these chemicals is dictated by the levels of PACs. Whilst most chemicals in the group are expected to be highly refined, verification by testing or reviewing the refining process would be needed to determine the hazardous properties. Mineral oils containing <3 % w/w dimethylsulfoxide (DMSO) extractables (as measured by the IP346 assay) are considered highly or severely refined. Only white oils are considered highly refined by definition (ACGIH, 2011; API, 2011; US EPA, 2011; IARC, 2012).

Australian

The following Australian industrial uses were reported under previous mandatory and/or voluntary calls for information.

The following chemicals are reported to have commercial use as lubricant base oils:

  • Lubricating oils, petroleum, C>25, hydrotreated bright stock based (CAS No. 72623-83-7);
  • Lubricating oils, petroleum, C15–30, hydrotreated neutral oil based, containing solvent deasphalted residual oil (CAS No.72623-84-8);
  • Lubricating oils, petroleum, C20–50, hydrotreated neutral oil based, high viscosity (CAS No. 72623-85-9);
  • Lubricating oils, petroleum, C15–30, hydrotreated neutral oil based (CAS No. 72623-86-0);
  • Lubricating oils, petroleum, C20–50, hydrotreated neutral oil based (CAS No. 72623-87-1); and
  • Hydrocarbons, C20–50, solvent dewaxed heavy paraffinic, hydrotreated (CAS No. 90640-95-2).

Identified functions include as:

  • surface-active agents;
  • heat transferring agents;
  • hydraulic fluids and agents;
  • fuel additives; and
  • viscosity adjusters.

The following chemicals are reported to have only site-limited uses:

  • Distillates, petroleum, light paraffinic (CAS No. 64741-50-0);
  • Distillates, petroleum, heavy paraffinic (CAS No. 64741-51-1);
  • Distillates, petroleum, light naphthenic (CAS No. 64741-52-2);
  • Distillates, petroleum, heavy naphthenic (CAS No.64741-53-3);
  • Distillates, petroleum, heavy hydrocracked (CAS No. 64741-76-0);
  • Distillates, petroleum, solvent refined heavy paraffinic (CAS No. 64741-88-4);
  • Distillates, petroleum, solvent refined light paraffinic (CAS No. 64741-89-5);
  • Residual oils, petroleum, solvent deasphalted (CAS No. 64741-95-3);
  • Distillates, petroleum, solvent refined heavy naphthenic (CAS No. 64741-96-4);
  • Distillates, petroleum, solvent refined light naphthenic (CAS No. 64741-97-5);
  • Residual oils, petroleum, solvent, refined (CAS No. 64742-01-4);
  • Distillates, petroleum, acid treated heavy naphthenic (CAS No. 64742-18-3);
  • Distillates, petroleum, acid treated light naphthenic (CAS No. 64742-19-4);
  • Distillates, petroleum, acid treated heavy paraffinic (CAS No. 64742-20-7);
  • Distillates, petroleum, acid treated light paraffinic (CAS No. 64742-21-8);
  • Distillates (petroleum), chemically neutralized light paraffinic (CAS No. 64742-28-5);
  • Distillates, petroleum, chemically neutralized heavy naphthenic (CAS No. 64742-34-3);
  • Distillates, petroleum, chemically neutralized light naphthenic (CAS No. 64742-35-4);
  • Distillates, petroleum, clay-treated heavy paraffinic (CAS No. 64742-36-5);
  • Distillates, petroleum, clay-treated light paraffinic (CAS No. 64742-37-6);
  • Distillates, petroleum, clay-treated heavy naphthenic (CAS No. 64742-44-5);
  • Distillates (petroleum), clay-treated light naphthenic (CAS No. 64742-45-6);
  • Lubricating oils, petroleum, clay-treated spent (CAS No. 64742-50-3)
  • Distillates, petroleum, hydrotreated heavy naphthenic (CAS No. 64742-52-5);
  • Distillates, petroleum, hydrotreated light naphthenic (CAS No. 64742-53-6);
  • Distillates, petroleum, hydrotreated heavy paraffinic (CAS No. 64742-54-7);
  • Distillates, petroleum, hydrotreated light paraffinic (CAS No. 64742-55-8);
  • Distillates, petroleum, solvent dewaxed light paraffinic (CAS No. 64742-56-9);
  • Residual oils, petroleum, hydrotreated (CAS No. 64742-57-0);
  • Lubricating oils, petroleum, hydrotreated spent (CAS No. 64742-58-1);
  • Residual oils, petroleum, solvent, dewaxed (CAS No. 64742-62-7);
  • Distillates, petroleum, solvent dewaxed heavy naphthenic (CAS No. 64742-63-8);
  • Distillates, petroleum, solvent dewaxed light naphthenic (CAS No. 64742-64-9);
  • Distillates, petroleum, solvent dewaxed heavy paraffinic (CAS No. 64742-65-0);
  • Naphthenic oils (petroleum), catalytic dewaxed heavy (CAS No. 64742-68-3);
  • Naphthenic oils (petroleum), catalytic dewaxed light (CAS No. 64742-69-4);
  • Paraffin oils, petroleum, catalytic dewaxed heavy (CAS No. 64742-70-7);
  • Paraffin oils, petroleum, catalytic dewaxed light (CAS No. 64742-71-8);
  • Extracts, petroleum, heavy paraffinic distillates, solvent deasphalted (CAS No. 68814-89-1);
  • Lubricating oils, petroleum, hydrocracked, nonaromatic, solvent deparaffined (CAS No. 92045-43-7);
  • Hydrocarbons, hydrocracked paraffinic distillation residues, solvent dewaxed (CAS No. 93763-38-3);
  • Distillates, petroleum, solvent refined hydrocracked light (CAS No. 94733-09-2);
  • Lubricating oils, petroleum, C18–40, solvent dewaxed, hydrocracked, distillate based (CAS No. 94733-15-0);
  • Distillates, petroleum, hydrocracked solvent refined light (CAS No. 97488-73-8); and
  • Lubricating oils, petroleum, C18–27, hydrocracked solvent dewaxed (CAS No. 97488-95-4).

International

In general the chemicals have reported commercial and site-limited uses including:

  • as solvents;
  • as industrial lubricants including engine oils, transmission fluids, gear oils, hydraulic fluids, metalworking oils, greases, heat transfer oils, machine oils, spray oils, tyre oils and general purpose oils; and
  • in printing inks (US EPA, 2011; IARC, 2012).

The following chemicals have reported use, up to a concentration of 100 % , as grease/lubricants, oils and oil additives, e.g. motor oil; and in power steering fluid and transmission fluids (US Department of Health and Human Services, Household Products Database (HHPD):

  • Distillates, petroleum, solvent refined heavy paraffinic (CAS No. 64741-88-4);
  • Distillates, petroleum, solvent refined light paraffinic (CAS No. 64741-89-5);
  • Residual oils, petroleum, solvent deasphalted (CAS No. 64741-95-3);
  • Distillates, petroleum, solvent refined heavy naphthenic (CAS No. 64741-96-4);
  • Distillates, petroleum, solvent refined light naphthenic (CAS No. 64741-97-5);
  • Residual oils, petroleum, solvent, refined (CAS No. 64742-01-4);
  • Distillates, petroleum, clay treated heavy paraffinic (CAS No. 64742-36-5);
  • Distillates, petroleum, hydrotreated heavy naphthenic (CAS No. 64742-52-5);
  • Distillates, petroleum, hydrotreated light naphthenic (CAS No. 64742-53-6);
  • Distillates, petroleum, hydrotreated heavy paraffinic (CAS No. 64742-54-7);
  • Distillates, petroleum, hydrotreated light paraffinic (CAS No. 64742-55-8);
  • Distillates, petroleum, solvent dewaxed light paraffinic (CAS No. 64742-56-9);
  • Residual oils, petroleum, hydrotreated (CAS No. 64742-57-0);
  • Lubricating oils, petroleum, hydrotreated spent (CAS No. 64742-58-1);
  • Residual oils, petroleum, solvent, dewaxed (CAS No. 64742-62-7);  
  • Distillates, petroleum, solvent dewaxed heavy naphthenic (CAS No. 64742-63-8);
  • Distillates, petroleum, solvent dewaxed heavy paraffinic (CAS No. 64742-65-0);
  • Lubricating oils, petroleum, C15–30, hydrotreated neutral oil based (CAS No. 72623-86-0); and
  • Lubricating oils, petroleum, C20–50, hydrotreated neutral oil based (CAS No. 72623-87-1).

These products may be used by members of the public for car maintenance activities.

The chemicals' distillates, petroleum, heavy hydrocracked (CAS No. 64741-76-0) and distillates, petroleum, hydrotreated light paraffinic (CAS No. 64742-55-8) are included in the CosIng database and US Personal Care Products Council INCI directory with the identified functions of solvents and conditioning agents e.g. emollients. However, there is currently no documented use of distillates, petroleum, hydrotreated light paraffinic (CAS No. 64742-55-8), and distillates, petroleum, heavy hydrocracked (CAS No. 64741-76-0) had a low reported frequency of use (less than five products) (Personal Care Products Council, 2011).

Australian

No known restrictions have been identified.

International

The chemicals, with the exception of lubricating oils, petroleum, clay-treated spent (CAS No. 64742-50-3); lubricating oils, petroleum, hydrotreated spent (64742-58-1); lubricating oils, petroleum, C>25, hydrotreated bright stock based (72623-83-5); and lubricating oils, petroleum, C15–30, hydrotreated neutral oil based, containing solvent deasphalted residual oil (72623-84-8), are listed on the following (Galleria Chemica):

Cosmetics

  • ASEAN Cosmetic Directive Annex II Part 1: List of substances which must not form part of the composition of cosmetic products;
  • EU Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products—Annex II—List of substances prohibited in cosmetic products;
  • New Zealand Cosmetic Products Group Standard—Schedule 4: Components cosmetic products must not contain—Table 1.

Other

  • Annex XVII to REACH Regulation as follows:

    'Shall not be used in substances and preparations placed on the market for sale to the general public in individual concentration equal to or greater than: either the relevant concentration specified in Annex I to Directive 67/548/EEC, or the relevant concentration specified in Directive 1999/45/EC.'

Existing Worker Health and Safety Controls

Hazard Classification

All the chemicals with the exception of lubricating oils, petroleum, clay-treated spent (CAS No. 64742-50-3); lubricating oils, petroleum, hydrotreated spent (64742-58-1); lubricating oils, petroleum, C>25, hydrotreated bright stock based (72623-83-7) and lubricating oils, petroleum, C15–30, hydrotreated neutral oil based, containing solvent deasphalted residual oil (72623-84-8) are classified as hazardous, with the following risk phrases for human health in the Hazardous Substances Information System (HSIS) (Safe Work Australia):

Carc. Cat. 2; R45 (carcinogenicity)

These classifications are subject to notes H and L.

'Note H: The classification and label shown for this substance applies to the dangerous property(ies) indicated by the Risk Phrase(s) in combination with the category(ies) of danger shown. The manufacturers, distributors and importers of this substance shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exists for all other properties to classify and label the substance.'

'Note L: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by IP 346. This note only applies to certain complex oil-derived substances in Annex I.'

Australian

No specific exposure standards are available for specific chemicals. The exposure standard for oil mist, refined mineral is 5 mg/m³ time weighted average (TWA). The applicability of this exposure standard for the chemicals will depend on the level of refinement.

Guidance on the interpretation of workplace exposure standards for airborne contaminants provides advice that exposure to carcinogens should be eliminated or minimised so far as is reasonably practicable (Safe Work Australia, 2013).

International

The following exposure standards are identified (Galleria Chemica):

A number of countries have exposure standards for oil mist mineral including an exposure limit of 0.2–5 mg/m³ (TWA) in different countries such as the United Arab Emirates, Japan, Austria, United States of America (USA) and Canada; and a short-term exposure limit (STEL) of 3–10 mg/m³ in countries such as Sweden, Egypt, the USA, Canada, Singapore and Poland.

The American Conference of Governmental Industrial Hygienists (ACGIH) recommends a threshold limit value (TLV) of 5 mg/m³ (TWA) for pure, highly and severely refined mineral oils. The ACGIH does not recommend application of this TLV to poorly- and mildly-refined mineral oils. No TLV is assigned based on insufficient data, although an A2 suspected human carcinogen classification is assigned (ACGIH, 2011).

Toxicokinetics

No specific toxicokinetic data are available. Although absorption of the chemicals may be affected by chemical composition, absorption is expected to be slow by all routes of exposure based on the estimated partition coefficients (>6) (US EPA, 2011).

Particle size may influence the absorption of inhaled aerosols. Oil-filled macrophages have been found to accumulate in the lung (ACGIH, 2011).

Oral

Based on the available data, the chemicals in this group are considered to be of low acute toxicity following oral exposure (US EPA, 2011).

The chemicals identified by CAS Nos. 64742-53-6, 64752-54-7 and 64742-65-0 have a reported median lethal dose (LD50) in rats of greater than 5000 mg/kg bw.

Dermal

Based on the available data, the chemicals in this group are considered to be of low acute toxicity following dermal exposure.

The chemicals identified by CAS Nos. 64742-53-6, 64752-54-7 and 64742-65-0 have a reported median lethal dose (LD50) in rabbits of greater than 2000 mg/kg bw. Signs of skin irritation (slight to severe for erythema and oedema and desquamation) were observed in some studies (US EPA, 2011; REACH)

Inhalation

Based on data available, the chemicals in this group are expected to have low to moderate toxicity following inhalation exposure. Based on the reported median lethal concentration (LC50) value (2.18 mg/L/4-h) for an insufficiently refined oil, classification is considered appropriate for the chemicals in this group (see Recommendation). However, this classification need not apply for highly or severely refined oils, containing <3 % w/w dimethylsulfoxide (DMSO) extractables (as measured by the IP346 assay).

In an acute inhalation toxicity study, rats were exposed to an aerosol of the chemical identified by CAS No. 64742-53-6 at concentrations of 1, 1.5, 2.5, 3.5 and 5 mg/L for four hours. All the animals in the two high dose groups, and three males and three females in the 2.5 mg/L dose group died. The LC50 was 2.18 mg/L/4-h.  Observed sublethal effects included decreased activity, rapid breathing and congestion, and inflammation of the lungs. The test chemical was reported to have a DMSO extractable content of >3 % as measured by the IP346 assay (US EPA, 2011; REACH).

Two further acute inhalation studies were available for the chemical identified by CAS No. 64742-53-6. In a single dose study in rats, 80 % mortality was observed at 5.7 mg/L/4-h. The DMSO extractable content was not reported. In another rat study, the LC50 was reported to be 10.5 mg/L/4-h for males and 9.5 mg/L/4-h for females. The cause of death appeared to be associated with lung congestion and/or oedema. The test chemical was reported to be highly or severely refined oils containing <3 % w/w DMSO extractables (REACH).

The chemical identified by CAS number 65741-88-4 has a reported LC50 of 3.9 mg/L/4-h (US EPA, 2011). The DMSO extractable content was not reported.

Acute inhalation data were available for several highly or severely refined oils containing <3 % w/w DMSO extractables. In general, no mortalities were observed (Dalbey et al., 2008; US EPA, 2011; REACH).

Skin Irritation

Based on the available data for an insufficiently refined oil, classification is considered appropriate for the chemicals in this group (see Recommendation). However, this classification need not apply for highly or severely refined oils containing <3 % w/w DMSO extractables (as measured by the IP346 assay).

A chemical in this group (CAS No. 64742-53-6) produced erythema and oedema (mean scores greater than two over 72 hours for both endpoints) following application to intact rabbit skin. Effects were fully reversible within 14 days. The test chemical was reported to have a DMSO extractable content (as measured by the IP346 assay) of >3 % (US EPA, 2011; REACH). Signs of skin irritation were also noted in repeated dose dermal toxicity studies with chemicals identified by CAS Nos. 64741-88-4, 64742-56-9 and 64742-65-0 (see Repeated dose toxicity: dermal).

Animal skin irritation data were available for several highly or severely refined oils containing <3 % w/w DMSO extractables. In general, slight skin irritation effects were considered to be not sufficient for classification (REACH). These minimally irritant effects are consistent with irritant responses observed in humans (see Observation in humans).

Eye Irritation

Based on the data available, the chemicals are considered to be, at most, slightly irritating to eyes.

A chemical in this group (CAS No. 64742-53-6) is reported to be a slight eye irritant in animal studies. Effects were not sufficient to warrant a hazard classification (US EPA, 2011; REACH).

Observation in humans

Very slight irritant effects were observed in four separate repeated insult patch tests in human volunteers with highly or severely refined oils, containing <3 % w/w DMSO extractables (REACH).

Skin Sensitisation

The limited data available do not indicate a potential for skin sensitisation.

The chemicals (CAS Nos. 64742-65-0 and 64742-53-6) were negative in Buehler-type studies in guinea pigs (US EPA 2011; REACH).

Oral

No data are available.

Dermal

The systemic toxicity of high-boiling petroleum substances (HBPS), such as the chemicals in this group, may be correlated with concentrations of PACs, particularly those composed of 3,4,5,6 and/or 7 fused aromatic rings. Although other compositional characteristics may influence toxicity (TERA, 2008), the systemic toxicity of the chemicals is expected to be correlated with the level of refinement of the chemicals. An analysis of several dermal toxicity studies for HBPS indicate the sensitive endpoints for repeated dose toxicity which include changes in organ weight (decreased thymus weight and increased liver weights) and changes in haematological parameters (decreased haemoglobin concentrations and decreased platelet count) (Feuston et al., 1994; Simpson et al. 2008).

Minimal systemic effects have been observed for the chemicals in this group that have been tested.

In separate 4-week single-dose studies, New Zealand White rabbits were dermally exposed to 1000 mg/kg bw/day of the chemicals identified by CAS Nos. 64741-88-4, 64742-56-9 and 64742-65-0. There were no significant signs of systemic toxicity. Signs of irritation were observed both macroscopically (erythema and oedema) and microscopically (inflammation, hyperplasia and hyperkeratosis).

In a 13-week study, Sprague Dawley (SD) rats were dermally exposed to 800 or 2000 mg/kg bw/day, for five days a week. The no observed adverse effect level (NOAEL) for systemic effects was reported as 800 mg/kg bw/day based on increased liver weights and histopathological changes observed in high-dose females. Signs of irritation were observed at both dose levels, both macroscopically (erythema and oedema) and microscopically (inflammation, hyperplasia and hyperkeratosis). As application sites were not covered, exposure may have been less than intended (US EPA, 2011).

Increased liver weights were also observed in a 3-week dermal study with CAS No. 64742-70-7. In this study, SD rats were dermally exposed to 1720 mg/kg bw/day (five days/week). Effects were observed in both males and females. As application sites were not covered, exposure may have been less than intended (US EPA, 2011).

Inhalation

The chemicals identified by CAS Nos. 64752-54-7 and 64742-70-7 produced effects in the lungs of rats exposed to aerosols for up to four weeks. Effects included increased lung weight and an accumulation of alveolar macrophages in lungs consistent with oil deposition. The lowest observed effect concentration (LOEC) was 0.05 mg/L/day (US EPA, 2011).

Genotoxicity

Mixed results from genotoxicity studies are available. The chemical (CAS No. 64741-88-4) was positive in a bacterial mutation assay in strain TA98. The results for the chemical CAS No. 64742-53-6 were positive in an in vitro mouse lymphoma mutation assay but the results for CAS No. 64742-52-5 were negative in a similar study (US EPA, 2011).

In an in vivo bone marrow cytogenic assay in rats, the chemical CAS No. 64742-56-9 did not induce any significant aberrations. The chemical CAS No. 64741-96-4 also has been reported not to induce any chromosome aberrations in vivo (US EPA, 2011).

The genetic toxicity of the chemicals is expected to be related to the level of refinement and associated removal of PACs and can be verified with screening tests such as the optimised Ames test and/or the IP346 test. 'The modified Ames test measures the amount of extractable mutagenic activity in a mineral-oil sample; mineral oils with a mutagenicity index = 1.0 in this assay are considered highly or severely refined. The IP346 assay measures the amount of material extractable in dimethyl sulfoxide (DMSO): mineral oils with a DMSO-extractable content < 3% in the IP346 assay are considered highly or severely refined.' (IARC, 2012).

Carcinogenicity

All the chemicals with the exception of lubricating oils, petroleum, clay-treated spent (CAS No. 64742-50-3); lubricating oils, petroleum, hydrotreated spent (CAS No. 64742-58-1); lubricating oils, petroleum, C>25, hydrotreated bright stock based (72623-83-7) and lubricating oils, petroleum, C15–30, hydrotreated neutral oil based, containing solvent deasphalted residual oil (CAS No. 72623-84-8) are classified as hazardous, Category 2 carcinogens with the risk phrase ‘May cause cancer’ (T; R45) in HSIS (Safe Work Australia). The classification need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP346. The available data support this classification for all chemicals in this group.

Skin tumours have been observed in mice following exposure to several unrefined or mildly refined base oils (NICNAS). In a dermal carcinogenicity study in mice, a chemical in this group (CAS No. 64742-53-6) increased the incidence of skin tumours. Petroleum substances containing <3 % w/w dimethylsulfoxide (DMSO) extractables (as measured by the IP346 assay), or which are negative in the modified Ames test (mutagenicity index <1) are not carcinogenic to skin (IPIECA, 2010).  

The International Agency for Research on Cancer (IARC) has evaluated the carcinogenicity of several subcategories of lubricant base oils and has determined that:

'There is sufficient evidence for the carcinogenicity in experimental animals of untreated vacuum distillates, acid-treated oils, and aromatic oils, including extracts from solvent treatment of distillates and the high-boiling fraction of catalytically cracked oils (classes 1, 2 and 6).

There is sufficient evidence that mildly solvent-refined oils (class 3) are carcinogenic to experimental animals. There is no evidence that severely solvent-refined oils (class 3) are carcinogenic to experimental animals.

There is sufficient evidence that mildly hydrotreated oils (class 4) are carcinogenic to experimental animals; the available data on severely hydrotreated oils (class 4) are inadequate to permit an evaluation of their carcinogenicity to experimental animals' (IARC, 1984). This was supported by the later evaluation (IARC, 2012).

No data are available for the chemicals.

Certain petroleum streams have been shown to be developmentally toxic from dermal exposure. Effects include increased incidence of resorptions and decrease in foetal body weight (IPIECA, 2010; Murray et al., 2013). Similar embryotoxic effects have been described in laboratory animals exposed to PACs such as benz [a]anthracene, benzo[a]pyrene, and naphthalene (EHC, 1998).

Unrefined and mildly refined base oils were recommended for classification for developmental effects (NICNAS). This classification is considered appropriate for the chemicals in this group (see Recommendation), although need not apply for highly or severely refined oils.

The developmental toxicity of HBPS, such as the chemicals in this group, may be correlated with concentrations of PACs, particularly those composed on 3,4,5,6 and/or 7 fused aromatic rings (Feuston et al., 1994; Murray et al. 2013). Although other compositional characteristics may influence toxicity (TERA, 2008), the developmental toxicity of the chemicals is expected to be correlated with the level of refinement of the chemicals.

Whilst a predictive test for the developmental effects of HBPS has not been developed (IPIECA, 2010), the associated developmental effects (increased incidence of resorptions and decrease in foetal body weight) have been shown to be significantly correlated with the mutagenicity index (Feuston et al., 1994). Therefore, in the absence of more information, the current note L that applies to the carcinogenicity classification is also considered appropriate for the developmental classification.

Critical Health Effects

The critical health effects for chemicals in this group are dependent upon the level of refinement. For highly or severely refined oils (oils with a DMSO-extractable content <3 % in the IP346 assay), the critical health effects are systemic acute effects (acute toxicity by the inhalation route of exposure) and local effects (skin irritation). Exposure to mists may also cause respiratory symptoms such as cough and phlegm.

For less refined oils (DMSO-extractable content >3 % in the IP346 assay), the additional critical health effects are systemic and long-term carcinogenicity and developmental toxicity.

Public Risk Characterisation

Based on the available use information (see Import, manufacture and use), the most significant source of public exposure will be through using auto products such as motor oils during car maintenance activities. Therefore, widespread public exposure is not expected, with exposure limited to hobbyists.

Whilst most chemicals in the group are expected to be highly refined, verification by testing or reviewing the refining process would be needed to determine the hazardous properties. Auto products available to consumers are also expected to be available in the workplace, and subject to workplace labelling. Workplace labelling will identify the hazards of any products containing chemicals with a DMSO-extractable content >3 % in the IP346 assay. Hence, the public risk from these chemicals is not considered to be unreasonable.

Occupational Risk Characterisation

During product formulation, dermal, ocular and inhalation exposure of workers to these chemicals may occur, particularly where manual or open processes are used. These may include transfer and blending activities, quality control analysis, and cleaning and maintaining equipment. Worker exposure to the chemicals at lower concentrations may also occur while using formulated products containing these chemicals. The level and route of exposure will vary depending on the method of application and work practices employed.

Given the critical systemic long-term, systemic acute and local health effects, the chemicals may pose an unreasonable risk to workers unless adequate control measures to minimise dermal and inhalation exposure to the chemicals are implemented. The chemicals should be appropriately classified and labelled to ensure that a person conducting a business or undertaking (PCBU) at a workplace (such as an employer) has adequate information to determine appropriate controls.

The Guidance on the interpretation of workplace exposure standards for airborne contaminants provides advice that exposure to carcinogens should be eliminated or minimised so far as is reasonably practicable (Safe Work Australia, 2013). The controls expected to be in place due to the carcinogenicity classification are considered to be sufficient to protect workers from any potential developmental and non-cancer systemic effects.

The data available support an amendment to the hazard classification in HSIS (refer to Recommendation section)

NICNAS Recommendation

Assessment of these chemicals is considered to be sufficient, provided that the recommended amendment to the classification is adopted, and labelling and all other requirements are met under workplace health and safety and poisons legislation as adopted by the relevant state or territory.

Work Health and Safety

The chemicals are recommended for classification and labelling under the current approved criteria and adopted GHS as below. This assessment does not consider classification of physical hazards and environmental hazards.

The current HSIS classification for carcinogenicity of these chemicals indicates notes L and H. Based on this assessment, all of the classifications provided below should be subject to note L. Therefore, note L should be slightly modified as follows:

'Note L: The classifications need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by the IP346 assay. This note only applies to certain complex oil-derived substances in Annex I.'

Note H is no longer considered relevant for these chemicals.

Hazard Approved Criteria (HSIS)a GHS Classification (HCIS)b
Acute Toxicity Harmful by inhalation (Xn; R20) Harmful if inhaled - Cat. 4 (H332)
Irritation / Corrosivity Irritating to skin (Xi; R38) Causes skin irritation - Cat. 2 (H315)
Carcinogenicity Carc. Cat 2 - May cause cancer (T; R45)* May cause cancer - Cat. 1B (H350)
Reproductive and Developmental Toxicity Repro. Cat 3 - Possible risk of harm to the unborn child (Xn; R63) Suspected of damaging the unborn child - Cat. 2 (H361d)

a Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)].

b Globally Harmonized System of Classification and Labelling of Chemicals (GHS) United Nations, 2009. Third Edition.

* Existing Hazard Classification. No change recommended to this classification

Advice for consumers

Products containing these chemicals should be used according to the instruction on the label.

Advice for industry

Control measures

Control measures to minimise the risk from dermal and inhalation exposure to the chemicals should be implemented in accordance with the hierarchy of controls. Approaches to minimise risk include substitution, isolation and engineering controls. Measures required to eliminate or minimise risk arising from storing, handling and using a hazardous chemical depend on the physical form and the manner in which the chemical is used. Examples of control measures which may minimise the risk include, but are not limited to:

  • using closed systems or isolating operations;
  • using local exhaust ventilation to prevent the chemical from entering the breathing zone of any worker;
  • minimising manual processes and work tasks through automating processes;
  • work procedures that minimise splashes and spills;
  • regularly cleaning equipment and work areas; and
  • using protective equipment that is designed, constructed, and operated to ensure that the worker does not come into contact with the chemical.

Guidance on managing risks from hazardous chemicals are provided in the Managing risks of hazardous chemicals in the workplace—Code of practice  available on the Safe Work Australia website.

Personal protective equipment should not solely be relied upon to control risk and should only be used when all other reasonably practicable control measures do not eliminate or sufficiently minimise risk. Guidance in selecting personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.

Obligations under workplace health and safety legislation

Information in this report should be taken into account to assist with meeting obligations under workplace health and safety legislation as adopted by the relevant state or territory. This includes, but is not limited to:

  • ensuring that hazardous chemicals are correctly classified and labelled;
  • ensuring that (material) safety data sheets ((m)SDS) containing accurate information about the hazards (relating to both health hazards and physicochemical (physical) hazards) of the chemical are prepared; and
  • managing risks arising from storing, handling and using a hazardous chemical.

Your work health and safety regulator should be contacted for information on the work health and safety laws in your jurisdiction.

Information on how to prepare an (m)SDS and how to label containers of hazardous chemicals are provided in relevant codes of practice such as the Preparation of safety data sheets for hazardous chemicals— Code of practice and Labelling of workplace hazardous chemicals—Code of practice, respectively. These codes of practice are available from the Safe Work Australia website.

A review of the physical hazards of the chemical has not been undertaken as part of this assessment.

References

ACGIH (American Conference of Governmental Industrial Hygienists).  Documentation of the Threshold Limit Values for Chemical Substances, ACGIH Signature Publications, 7th Edition,  2011.

Dalbey W., F. Whitman, and M. Amoruso. 2008. Classification of aerosolized mineral base oils under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The Toxicologist, Supplement to Toxicological Sciences 102(1):221, Abstract No. 1077.

Feuston et al. Fundam Appl Toxicol. 1994 May; 22(4):622-30. Correlation of systemic and developmental toxicities with chemical component classes of refinery streams. Fundam Appl Toxicol. 1994 May; 22(4):622-30.

International Agency for Research on Cancer (IARC) 2012. A Review of Human Carcinogens: Chemical Agents and Related Occupations. Volume 100 F. Mineral Oils, Untreated or Mildly Treated. Accessed January 2014 at http://monographs.iarc.fr/ENG/Monographs/vol100F/

International Agency for Research on Cancer (IARC) Volume 33 (1984) Polynuclear Aromatic Compounds, Part 2: Carbon Blacks, Mineral Oils (Lubricant Base Oils and Derived Products) and Some Nitroarenes Accessed April 2014 at http://monographs.iarc.fr/ENG/Monographs/vol1-42/index.php

International Petroleum Industry Environmental Conservation Association (IPIECA) 2010. Guidance on the application of Globally Harmonized System (GHS) criteria to petroleum substances. Accessed January 2014 at http://www.ipieca.org/publication/guidance-application-globally-harmonized-system-ghs-criteria-petroleum-substances

IPCS Environmental Health Criteria (EHC) 202 (1998). Selected non-heterocyclic polyaromatic hydrocarbons. Accessed on January 2014 at http://www.inchem.org/documents/ehc/ehc/ehc202.htm

Murray et al. (2013) The relationship between developmental toxicity and aromatic-ring class profile of high-boiling petroleum substances. Regulatory Toxicology and Pharmacology, Volume 67, Issue 2, Supplement, 1 November 2013, Pages S46–S59

National Industrial Chemical Notification and Assessment Scheme (NICNAS). Tier II Human health assessment for Unrefined or mildly refined base oils. Australian Government Department of Health.  Accessed March 2014 at http://www.nicnas.gov.au/chemical-information/imap-assessments/imap-group-assessment-report?assessment_id=948

Personal Care Products Council 2011. Compilation of Ingredients Used in Cosmetics in the United States, 1st Edition.

REACH Dossier CAS No. 64742-53-6 (REACH). Accessed March 2014 at http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances

Simpson et al. (2008). The Relationship between the Aromatic Ring Class Content and Repeat-dose and Developmental Toxicities of Petroleum Substances Boiling above Approximately 300 ºF. The Toxicologist, Supplement to Toxicological Sciences 102(1):52, Abstract No. 254

TERA (Toxicology Excellence for Risk Assessment). 2008. Report of the Peer Consultation on Relationship between PAC Profile and Toxicity of Petroleum Substances Volume I. Accessed January 2014 at http://www.tera.org/peer/API/PAC%20MEETING%20REPORT%20Final.pdf

US Department of Health and Human Services, Household Products Database (HHPD), Health and safety information on household products. Accessed March 2014 at http://householdproducts.nlm.nih.gov/

US Environmental Protection Agency (2011). Screening level hazard characterization Lubricating Oil Basestocks Category. Accessed January 2014 at http://www.epa.gov/chemrtk/hpvis/hazchar/Category_Lubricating%20Oil%20Basestocks_September_2011.pdf

Last Update 04 July 2014