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«HEALTH RISK ASSESSMENT: METHYLATED SPIRITS Prepared as part of a Ministry of Health contract for scientific services by Dr Beverley Horn October 2014 ...»

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HEALTH RISK ASSESSMENT:

METHYLATED SPIRITS

Prepared as part of a Ministry of Health

contract for scientific services

by

Dr Beverley Horn

October 2014

Client Report FW14046

DISCLAIMER

This report or document (“the Report”) is given by the Institute of Environmental

Science and Research Limited (“ESR”) solely for the benefit of the Ministry of Health

(“MoH”), Public Health Services Providers and other Third Party Beneficiaries as defined in the Contract between ESR and the MoH, and is strictly subject to the conditions laid out in that Contract.

Neither ESR nor any of its employees makes any warranty, express or implied, or assumes any legal liability or responsibility for use of the Report or its contents by any other person or organisation.

Hazardous Substances Risk Assessment: December 2014 i Methylated Spirits CONTENTS EXECUTIVE SUMMARY

1. INTRODUCTION

1.1 Purpose

1.2 Consumer Products Description – Methylated Spirits

2 HAZARD IDENTIFICATION

2.1 Absorption and metabolism

2.2 Acute Toxicity of Similar Products and Associated Ingredients.............. 4 2.3 Irritation

2.4 Sensitisation

2.5 Genotoxicity

2.6 Chronic toxicity and carcinogenicity

2.7 Risk Assessments

2.8 At Risk and Vulnerable Groups

2.9 Methylated Spirits Injuries and Use Patterns

2.9.1 New Zealand

2.9.2 Pacific Islands

2.9.3 Other countries

2.10 Summary

3 DOSE-RESPONSE

3.1 Introduction

3.2 Methylated Spirits Components

3.2.1 Ethanol

3.2.2 Non-ethanol ingredients

3.3 Estimated Toxicity of Methylated Spirits

3.3.1 Acute

3.3.2 Chronic

4 EXPOSURE ASSESSMENT

4.1 Exposure scenarios for methylated spirits in New Zealand.................. 23 4.2 Incidental exposure by young children

4.2.1 Child - Ocular exposure

4.2.2 Child - Oral exposure

4.2.3 Child - Dermal exposure

4.2.4 Child – Inhalation exposure

4.3 Exposure during household cleaning.

4.3.1 Ocular

4.3.2 Dermal

4.3.3 Inhalation

4.4 Other exposure pathways

4.4.1 Camp stove fuel

4.4.2 Habitual drinkers

5 RISK CHARACTERISATION

5.1 Acute systemic exposure

5.2 Chronic dermal exposures

Hazardous Substances Risk Assessment: December 2014 ii Methylated Spirits

5.3 Local (concentration-based) effects

5.3.1 Skin effects

5.3.2 Eye effects

6 CONCLUSIONS

7 REFERENCES

–  –  –

Table 1: Description of methylated spirits formulations commonly available to New Zealand public

Table 2: Maximum blood alcohol concentration achieved after repeated use of ethanol based rub (Kramer et al 2007).

Table 3: Dermal irritation information for methylated spirits ingredients................. 6 Table 4: Estimated prevalence (%) of 15 year old students from three Pacific Islands who had ever used methylated spirits.

Table 5: Concentration (%w/w) of ingredients found in methylated spirit products in New Zealand

Table 6: Blood alcohol concentrations and associated effects from oral consumption of methylated spirits at 99% and 70% ethanol levels for different population groups

Table 7: Relative risk of cancer and non-cancer conditions at different chronic intakes of alcohol and the equivalent dose of methylated spirits (Corrao et al 2004).

Table 8: Lowest recorded oral doses associated with toxicological effects for individual non-ethanol ingredients in methylated spirits.

Table 9: Inhalation concentration response information for methylated spirits ingredients

Table 10: Lowest median animal lethal acute doses for oral, dermal and inhalation exposures to ingredients of methylated spirits found in the literature.... 21 Table 11: Estimated human acute toxicity LD/C50 estimates for methylated spirits based on animal studies

Table 12: Child (2 - 3 year old) estimated exposures from ingested methylated spirits.

Table 13: Dermal absorption exposure estimate for an child (2 to 3 year old) spilling methylated spirits

Table 14: Exposure model for methylated spirits used for household cleaning....... 30 Table 15: Summary of acute systemic exposure scenarios for methylated spirits (99% ethanol) and the associated health effects from the ethanol component

Table 16: Margin of exposure estimates for methylated spirit solutions used during household cleaning scenarios. Interval reflects the expected time range the activity is likely to be undertaken.

LIST OF TABLES

Figure 1: Methylated spirits incidents causing Poison Centre calls for different nonworkplace exposure routes mid-2008 to end of 2012.

Figure 2: Child exposure pathways from incidental exposure

Figure 3: Proportion of children drinking different amounts of orange juice with denatonium benzoate additive (Sibert and Frude 1991)

Figure 4: Ethanol dose for different child weights and methylated spirits formulations

–  –  –

The purpose of this report is to develop a generic health risk assessment for methylated spirits intended for sale to the general public. This report will only consider domestic, non-occupational, exposure to methylated spirits.





Methylated spirits is a common household product which is readily available at a range of retail outlets. Methylated spirits is composed of 70–99% ethanol, water and denatonium benzoate. Other ingredients (concentration ≤0.25%) can include methyl isobutyl ketone, methyl violet and fluorescein. Denatonium benzoate is added to methylated spirits to make the product have an intensely bitter taste to reduce the amount of liquid likely to be consumed.

Data from the New Zealand Poisons Call Centre lists 60–80 calls a year relating to methylated spirits, ranking it between 6th and 12th annual most common cause of calls over the period 2008–2012. The majority of calls across all age groups relate to ingestion of methylated spirits. Smaller numbers of calls relate to eye, skin and inhalation exposures. Approximately 40% of calls relate to 0–3 year olds being exposed to methylated spirits during exploratory play.

Methylated spirits is not classified as acutely toxic, but ingestion of small quantities can cause serious health effects due to the high ethanol concentration.

Risk assessment of 2–3 year olds drinking and spilling methylated spirits during exploratory play suggests the scenario is unlikely to result in systemic toxicological risk if the denatonium benzoate acts as a deterrent to ingestion. There is no evidence supporting a toxicological risk from dermal or inhalation exposures for this scenario.

In the worst case scenario of a 2-3 year old child being undeterred by the bitterant and drinking 20–30 ml of methylated spirits, there are likely to be transient health effects relating to the central nervous system. Coma and death could result from a 2–3 year old drinking 50 ml of methylated spirits.

The use of methylated spirits for household cleaning by adults and children, resulting in dermal or inhalation exposure, is unlikely to represent a health risk.

Methylated spirits contacting with the eye will cause immediate discomfort and may damage the eye lasting over a week. Symptoms are likely to resolve within two weeks.

Risk assessment of chronic dermal exposure to methylated spirits during household cleaning by adults, results in a margin of exposure of between 22 and 89 using rat NOAELs as the benchmark dose. Safety factors of 100-1000 are typically applied to derive health-based exposure limits from toxicological NOAELS. On this basis, MoEs less than 100 may indicate a need for a more detailed risk assessment. Further data on the NOAEL of methylated spirit ingredients and the dermal and inhalation transfer rates at low concentrations would assist in reducing the uncertainty of this assessment.

–  –  –

The purpose of this report is to develop a generic health risk assessment for methylated spirits intended for sale to the general public. This report will only consider domestic, non-occupational, routine and incidental exposure to methylated spirits. In some instances, occupational exposure information will be used to contextualise non-occupational exposures, specifically in terms of adverse health outcomes and critical exposure levels.

Exposure scenarios were developed for the most common or likely exposure events to assess the health risk to exposed groups. Detailed scenarios resulting in injury due to the flammable nature of methylated spirits will not be considered in this risk assessment.

Methanol used to be a common denaturing ingredient in methylated spirits. Methanol is hazardous to human health and was banned in New Zealand as an ingredient in methylated spirits intended for public use in 20061. This risk assessment will not consider formulations including methanol.

1.2 Consumer Products Description – Methylated Spirits

Methylated spirits is a common household substance in New Zealand, which is used as a household cleaner and fuel for camping stoves or as a BBQ starter fuel. It is available through a wide range of retail shops including supermarkets, hardware, decorating, department, camping and automotive parts stores. In 2014 the cost ranged from $4 to $12 a litre.

Methylated spirits is a liquid product containing a high concentration of ethanol plus some form of denaturant to discourage it’s consumption by people. Ethanol is also referred to as ethyl alcohol in some of the report references. For consistency in the rest of this report, only the term ethanol will be used.

Methylated spirits is regulated in New Zealand by the Environmental Protection Agency Denatured Ethanol Group Standard 2006 1. There are three possible

formulations for denaturing ethanol intended for sale to the general public:

• 15.6 g denatonium benzoate per 1000 litres ethyl alcohol to be denatured (15.6 ppm) • 0.25% by volume methyl isobutyl ketone (MIBK) together with 5-10 g denatonium benzoate per 1000 litres of ethyl alcohol to be denatured (5-10 ppm) • 0.25% by volume tertiary butyl alcohol together with 10 g denatonium benzoate per 1000 litres of ethyl alcohol to be denatured (10 ppm).

http://www.epa.govt.nz/Publications/gs-denatured-ethanol.pdf Accessed 31 July 2014

Hazardous Substances Risk Assessment: December 2014 Methylated Spirits The group standard also states that “when a substance is packaged in quantities less than 5 L, that package must be child resistant unless being sold or supplied to a place of work where children do not have access and the substance is for use in that place of work.” A review of methylated spirits products available to the public from national retailers, internet retail sites and shops in Christchurch and Hamilton is summarised in Table 1.

Ingredient information was sourced from product material safety data sheets, product labels or correspondence with the producers. No formulations using tertiary butyl alcohol were found in domestic retail products and this formulation is not considered further in this assessment.

Table 1: Description of methylated spirits formulations commonly available to New Zealand public

–  –  –

The hazard identification considers the toxicological hazards associated with the product methylated spirits. Here, the product and each of its ingredients are reviewed for data relevant to evaluation of toxicity by all routes. Where key data are not available on the product or its ingredients, data gaps are identified.

2.1 Absorption and metabolism 2.1.1 Oral Ethanol is rapidly absorbed from the gastrointestinal tract into the blood stream providing systemic exposure to the chemical. Approximately 20% of consumed alcohol is absorbed into the blood stream via the stomach. The small intestine more efficiently absorbs alcohol and can absorb most of the alcohol left after the stomach (Health Protection Agency 2014).

Ethanol is metabolised in the body by enzymes, the primary ones are alcohol dehydrogenase, aldehyde dehydrogenase, specific forms of cytochrome P450 and catalase (Zakhari 2006). Most (90%) of the ethanol is metabolised by the liver with smaller amounts metabolised in the stomach. Some ethanol is excreted from the body via the lungs, via the kidneys into urine or in sweat.

MIBK is rapidly metabolised in the body to the major metabolite 4-hydroxy-4-methylpentanone (HMP; CAS No 123-42-2) which is also readily metabolised in the body.

Fluorescein and its metabolites are mainly eliminated via renal extraction, systemic clearance of 500 mg can occur in 72 hours.

2.1.2 Inhalation Ethanol vapour can be absorbed into the blood stream via inhalation. However it has not been shown in human studies to result in high enough blood alcohol concentrations to lead to adverse effects. Prolonged periods of inspiration of air containing alcohol at 2–12 mg/L result in absorption of 55%–60% of the inspired ethanol. However, some of the ethanol is thought to stay in the respiratory system and not enter the blood stream. (Campbell and Wilson 1986; Kruhoffer 1983).

2.1.3 Dermal Ethanol is not readily transferred to the blood stream through the skin. This is partially due to rapid evaporation of ethanol from the skin’s surface (Pendlington et al 2001).

Hazardous Substances Risk Assessment: December 2014 Methylated Spirits High concentrations of ethanol are a common ingredient in hand disinfectant rubs.

Repeated application of a 95% ethanol hand rub over a short period of time (Table 2) showed that ethanol could be transferred to the blood stream, but at low levels which would be easily metabolised by the body in a short time (Kramer et al 2007;

Wigmore 2009).

Table 2: Maximum blood alcohol concentration achieved after repeated use of ethanol based rub (Kramer et al 2007).

–  –  –

Animal experiments with guinea pigs showed that the methylated spirits component, MIBK, can be absorbed orally, by inhalation or through the skin and transferred to the arterial blood. In the guinea pigs a maximum percutaneous uptake of



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