Hazard Analysis of Disinfectants

The Hazard Analysis of Disinfectants is designed to compare the environmental and health related hazards of disinfectants with product alternatives. In a first step the substitution demand of a product is estimated. A substitution demand is assumed if the disinfectant contains ingredients with a huge and/or long-term adverse impact on human health or the environment. To identify such an impact a categorisation scheme is applied on the ingredient classification[1]. Thereby hazards (H-phrases) are assigned to a category. Substitution demand is assumed if a product contains at least one ingredient categorised as A (indicating high adverse impact). In this case the product is recommended for a Product Benchmarking with alternatives[2]. The aim of the benchmarking is to identify those products which are (most) suitable for substitution. As a prerequisite the alternatives have to be comparable in terms of application and biocidal efficacy. Hazardous loads thereby indicate the suitability for substitution as they are an estimate for the quantity of emission of (very) hazardous ingredients.

Figure 1: Overview – Hazard Analysis of Disinfectants

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The Analysis can be applied to hygienic and surgical hand disinfectants, skin disinfectants, surface-, instruments and linen disinfectants. Therefore information about products and their ingredients is needed. At least a safety data sheet including dangerous ingredients and their concentrations has to be provided for an Ingredient Analysis. Additional information about the type of application and spectrum of activity (biocidal efficacy) is needed for subsequent Product Benchmarking. If the benchmarked product is already listed in the WIDES database[3] this enables immediate access to product data as well as to potential product alternatives thereby facilitating the overall Analysis.

1. Step: Ingredient Analysis

The first step of the Analysis serves to estimate the substitution demand. Such a demand is assumed if the disinfectant contains ingredients with huge and/or long-term adverse impact on human health or the environment. To identify such an impact a categorisation scheme is applied.

Categorising hazards

The core idea is to differentiate hazards which are of high or very high concern from those which pose a controllable or minor concerning hazard. For this purpose a so called “ABC categorisation” is applied. The ABC categorisation is a scheme which differentiates three types of hazards.

Category A: Covers hazards which are thought to be of high concern with long-lasting and potentially irreversible adverse impacts. Considering their severity a strong recommendation for substitution is given. Criteria assigned to category A are given in Figure 2:

Figure 2: Criteria for Category A

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Category B: Covers hazards which are of considerable concern but which are not thought to automatically generate a substitution demand. Instead it should be decided on a case by case basis if a Product Benchmarking is indicated. Criteria assigned to category B are given in Figure 3 :

Figure 3: Criteria for Category B

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Category C: Hazards assigned to category C are thought to have a controllable or rather low impact on human health and the environment. They are not further considered in the Hazard Analysis and only presented for the sake of completeness. Criteria assigned to category C are given in Figure 4:

Figure 4: Criteria for Category C

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Example

Figure 5 shows products foreseen for Hazard Analysis. Basic information is given about the application. CAS number and H-phrases for hazardous ingredients can be gathered from the safety data sheet provided for each product (data not shown). These data are sufficient for the first step of the Analysis.  

Figure 5: Products foreseen for Hazard analysis

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Ingredient Analysis is demonstrated with product SD5. The product is listed in the WIDES database and the H-phrases of the ingredients are overtaken from there. SD5 includes 4 ingredients with hazardous properties (Figure 6). According to their classification two ingredients have H-phrases categorised as A:

  • Aminoalkylglycin: 2, H361 (Suspected of damaging the fertility); H372 (Causes damage to the organs through prolonged and repeated exposure)
  • Polyhexamethylenbiguanid-Hydrochlorid: Skin Sens. 1B, H317 (May cause an allergic skin reaction); Acute Tox. 2, H330 (Fatal if inhaled); Carc. 2, H351 (Suspected of causing cancer); STOT RE 1, H372 (Causes damage to the organs through prolonged and repeated exposure).

Figure 6: Hazard analysis oF Product SD5

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Figure 7: Summary of Hazard analysis of product SD1 to SD8

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The conclusions based on Ingredient Analysis are: No substitution demand is determined for SD7 and SD8. Since SD1, SD4 and SD6 include ingredients categorised as B a substitution demand is principally determined. However it should be decided on a case by case basis if a further Benchmarking is indicated. SD2, SD3 and SD5 include one or more ingredients categorised as A, so for them a substitution demand is determined.

2. Step: Product Benchmarking

In the second step – the Product Benchmarking – alternatives are searched for those products for which a substitution demand is determined. As a general rule additional information is needed: For the Ingredient Hazard Analysis it is sufficient to know the hazardous ingredients, however the Product Benchmarking additionally affords the concentrations of the hazardous ingredients both of the benchmarked product and the product alternatives – at least for those which show “benchmarked hazards” (see below). For the Ingredient Hazard Analysis it is not necessary to know the precise application conditions and (proven) biocidal efficacy. This is not the case for the Product Benchmarking since the benchmarked product and the alternatives have to be comparable in type application and (biocidal) efficacy.

The Product Benchmarking additionally requires a decision about which hazards should be compared. In principle it is possible to compare any hazard. But in order to get a meaningful result it is indicated to focus on hazards with huge adverse impacts. As an example: If an applicator wants to avoid hazards arising from proven carcinogenic, mutagenic, repro-toxic and chronically toxic properties or wants to keep them as low as possible he may achieve this by the following strategy: H-phrases indicating proven carcinogenic, mutagenic, repro-toxic and chronically toxic properties and H-phrases indicating suspected proven carcinogenic, mutagenic, repro-toxic and chronically toxic properties may be collected and termed “CMR & CT Hazard”. Following this strategy a set of “Benchmarked Hazards” may be created and applied in the Product Benchmarking.

Figure 8 shows a proposed set of 3 Benchmarked Hazards: “CMR & CT Hazard” capturing mutagenic, carcinogenic, repro-toxic and chronic toxic properties – both proven and suspected, a “Sensitising Hazard” capturing skin sensitisation as well as asthma induction via inhalation, a “Hazard to the Aquatic Life” capturing (very) high toxicity towards water organisms.

Figure 8: Set of Benchmarked Hazards

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Selecting product alternatives

As already mentioned product alternatives and the benchmarked product have to be comparable in application conditions and efficacy. There are two basic options to select product alternatives while ensuring claimed comparability.

The first option is to apply the WIDES database. The WIDES actually includes 300 disinfectants for hand-, skin-, surface-, instrument- and linen disinfection. Each disinfectant is specified in terms of application, spectrum of activity and product ingredients. To be incorporated in the WIDES a product has to be independently certificated for claimed efficacy. This guarantees that only properly effective products are listed. Further the selection mode of the WIDES guarantees that only products with comparable type of application and biocidal efficacy can be selected. The selection mode can be used to generate product alternatives by a few mouse clicks (compare Figure 10).      

The second option has to be applied if the benchmarked product is not listed in the WIDES or cannot be integrated due to lacking information. Then the assessor is obliged to search and provide documents which substantiate comparability between the benchmarked product and product alternatives. The ABC categorisation may be used for pre-selection by assigning the H-phrases of ingredients to a category. If ingredients with H-phrases categorised as A are identified the product is not suitable as an alternative.        

Calculating hazardous loads

For calculating hazardous loads the following information is required:

Concentration of ingredients: This information is required both for the benchmarked product and product alternatives and can be gathered from the safety data sheet. The information requirement may be limited to ingredients carrying benchmarked hazards.

Density: This information is required both for the benchmarked product and product alternatives and can be gathered from the safety data sheet.

Consumption volume: This information is required only for the benchmarked product. If the consumption volume is not available or unknown a default value of 1000 litres may be applied.

Application concentration (application volume): This information is required both for the benchmarked product and product alternatives. Depending on the type of product there are two ways to consider the application concentration for calculating the application volume:

  • Ready for use product: A ready for use product is not diluted and therefore the application concentration is 100%. In this case the consumption volume equals the application volume.  
  • Concentrate: A concentrate is diluted prior to application. In this case the consumption volume does not equal the application volume. Instead the application volume is calculated as follows: A concentrate applied in 0,5 % and with a consumption volume of 1000 litres results in 200.000 litres application solution. Product alternatives have to be related to this quantity of application solution: To generate 200.000 litres of application solution from a product alternative diluted to 1% 2000 litres of concentrate are needed.    

Based on this information the hazardous load is then calculated for each benchmarked hazard and each ingredient i separately. The hazardous load is a numerical value expressing the potential emission of benchmarked hazards of a single product with regard to the consumption (application) volume:

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Case study SD5

The case study exemplifies the benchmarking process illustrated above. For SD5 the Ingredient Hazard Analysis has constituted a substitution demand triggered by the ingredients Aminoalkylglycin and Polyhexamethylenbiguanid. The following (additional) information was collected to perform a Product Benchmarking:

Figure 9: Information needed to Benchmark SD5

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Benchmarked hazards: Are applied according to Figure 8.

Selection of product alternatives: Since SD5 is listed in the WIDES product alternatives were found there by applying the following procedure: After login and opening the module “Products” the application “Surface rfu non alcoholic” is activated. Then in the drop-down list the exposure time 0,5 – 15 min and the spectrum of activity “bactericidal (not Mycobacteria) + yeasticidal, dirty cond. + mechanic action” was selected followed by pressing “Go to assessment”. The resulting list shown in Figure 10 includes SD5 itself and 17 potential product alternatives together with the colour code of the WIDES assessment in five hazard categories.

Figure 10: SD5, Potential Product alternatives and WIDES Assessment

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The following product alternatives were selected based on a visual judgement of the colour fields: PA6 (Hydrogen peroxide), PA14 (Didecyldimethylammoniumchloride), PA3 (Didecyldimethylammoniumchloride, Benzalkoniumchloride), PA12 (Didecyldimethylammonium chloride, Benzalkoniumchloride, N-Alkyl-N-ethylbenzyl-N,N-dimethylammonium chloride).

Calculating hazardous loads:

By inserting data from Figure 9 the equation

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In the calculation multiple counting has to be avoided because one and the same ingredient physically can only share once to a hazardous load. As an explanation: Ingredient Polyhexamethylenbiguanid-HCl has two H-phrases (H372, H351) indicating “CMR & CT hazardous load”. The (double counted) hazardous load has to be “adjusted” according to:

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Figure 11: Hazardous loads of SD5

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Summary

For SD5 the Ingredient Hazard Analysis has constituted a substitution demand triggered by ingredients Aminoalkylglycin and Polyhexamethylenbiguanid. Therefore a subsequent Product Benchmarking was performed to search and propose product alternatives.

For an (assumed) consumption volume of 1000 litres an adjusted hazardous load of 18,9 kg „benchmarked hazard“ is calculated. This overall load consists of 6,2 kg hazardous load caused by proven or suspected CMR & CT properties, 1,2 kg hazardous load caused by sensitising properties and 11,5 kg hazardous load caused by toxicity to the aquatic environment.

17 potential product alternatives were selected from the WIDES database and PA6, PA14, PA12, PA3 further selected for Product Benchmarking. Their hazardous loads were calculated assuming a consumption volume of 1000 litres. The results are:

  • PA6, PA14, PA12, PA3 generate 0 kg hazardous load caused by proven or suspected mutagenic, carcinogenic, repro-toxic or chronically toxic properties,
  • PA6, PA14, PA12, PA3 generate 0 kg hazardous load caused by sensitising properties,
  • PA6 generates 0 kg, PA14 generates 4,5 kg, PA12 generates 7,2 kg and PA3 generates 7,5 kg hazardous load caused by toxicity to the aquatic environment.

Therefore all product alternatives PA6, PA14, PA12 and PA3 are possible candidates for substitution with priority for PA6

(NOTE: Material compatibilities respectively incompatibilities during product application of the product alternatives could not be considered in the Hazard Analysis and should be investigated and/or tested by the applicant on a case by case basis).

Figure 12: Benchmarking REsults for SD5 and 4 Product Alternatives

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[1] The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally standard managed by the UN. Core elements of the GHS include standardized hazard testing criteria, universal warning pictograms, and harmonized safety data sheets which provide users of dangerous goods with a host of information. https://en.wikipedia.org/wiki/Globally_Harmonized_System_of_Classification_and_Labelling_of_Chemicals).

[2] Benchmarking means the comparison of single attributes of a product or product portfolio with a „benchmark“. Normally the benchmark is a market leader within a product segment.

[3] The Viennese Database for Disinfectants (WIDES Database) contains information on the established effects of commercially available disinfectants and their ingredients as well as the properties of these products that are of relevance for occupational safety and environmental protection. https://www.wien.gv.at/english/environment/protection/oekokauf/disinfectants/index.html