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The SCCS opinion states:
INHERENT PROPERTIES OF CPRF AND CAP THAT MAY BE RESPONSIBLE FOR ADVERSE HEALTH EFFECTS UPON INGESTION
9.1. Acute toxicity of cosmetics
The safety of cosmetic products is not evaluated for oral intake, except for oral care products (Directive 76/768/EEC).
The cosmetic frame formulations (COLIPA and EAPCCT 2000) detail basic information about ingredient types and the maximum concentrations for most cosmetic ingredients on the European market. The frame formulations system enables rapid identification of a cosmetic product that is unlikely to result in serious effects to health, when ingested or used inappropriately. These are a voluntary initiative of the industry and have no current EU legal status, but are provided to the national competent authorities. If a product does not comply with a frame formulation, or if there is no frame formulation for a given product, then formulation details, both qualitative and quantitative, need to be declared individually. Also, some other types of cosmetic products (e.g. nail cuticle removers, nail strengtheners, nail varnish removers, permanent wave neutralisers in powder form) have always to be declared in detail to poison centres.
The majority of cosmetic products represent a relatively low risk upon ingestion. A list of ingredients that according to scientific evidence may cause serious effects to human health if ingested was established by the working group. This was based on their experience, as well as on the acute toxicity data for these substances by oral routes when available in the published literature/toxicity databases or in the dossiers evaluated by the SCCS.
Table 5 (Annex III) is derived from the frame formulations, indicating the categories and examples of chemicals. The selection of ingredients was based on the judgement of the SCCS experts using RAPEX listings, concentration and hazard of the substances.
9.2. Acute toxicity of household products
Currently there are no frame formulations available for household products, but they are included in the 2009 proposed Regulation that will repeal and replace the current Directive 98/8/EC concerning the placing of biocidal products on the market which is scheduled to come into force on 1 January 2013.
The current practice is to indicate the chemical types and the concentrations of the ingredients for the following ranges; <5%, 5-25%, 15-30% and >30%. The ingredient concentration of a specific chemical type varies between manufacturers for similar products.
Common household cleaning products (see Table 6, Annex III), most frequently cited in poisonings, are dishwashing and laundry detergents, toilet cleaners and bleaches (Wyke et al. 2009). Sodium hypochlorite, sodium hydroxide, alcohols and hydrogen peroxide were often cited in poisonings. Individually, these chemicals have a mild to low order of acute toxicity, e.g. surfactants have low acute toxicity of >2,000 mg/kg bodyweight in oral rat studies, with the exception of linear alkylbenzene sulphonates that have a toxicity of 1,500 mg/kg bodyweight. In mixtures, the combined action of the different types of surfactants may exacerbate the toxic effects of each other and also other ingredients present in low concentrations by increasing cell membrane permeability. However, as a rule of thumb, the Material Safety Data Sheets (MSDS) of the finished household product indicate a toxicity of >2,000 mg/kg bodyweight with an emetic dose of ~500 mg/kg bodyweight. Generally, pH, contact time, physical state, amount ingested, tritrable acid and alkaline reserve of the finished product are the most critical factors. Many of the chemicals are classified irritant or corrosive, due to either high or low pH.
Considering the main ingredients used in cosmetics and household chemical products and the substances involved in poisoning reported by poison centres or published papers (Lamireau et al. 1997, Lambert et al. 2000, Madden 2008, Madsen et al. 2001), the SCCS considers that the following substances should be considered as potential harmful ingredients after accidental ingestion:
- Corrosive substances such as acetic acid, sulphuric acid, hydrochloric acid, sodium bisulphate, sodium hypochlorite, sodium hydroxide and sodium phosphate.
- Some surfactant (depending on types and/or concentration).
- Alcohols and glycols such as ethanol, isopropanol and butyl glycol.
- Essential oils such as pine oil, wintergreen oil and camphor.
The toxicity of these substances will be briefly described in the Annex IV. Discussion of all potentially toxic ingredients used in cosmetic or household products is beyond the scope of this opinion.
Source & ©:
SCCS, 
and/or having child-
appealing properties,
(2011),
9. Inherent Properties Of Cprf And Cap That May Be
Responsible For Adverse Health Effects Upon Ingestion, pp. 22-23
The SCCS opinion states:
Annex IV: Toxicity of potential harmful ingredients
Corrosives are the main category of agents responsible for severe accidental poisonings from household chemical consumer products (Lambert et al. 2000, Lamireau et al. 1997).
Despite limitations, the available data suggest that corrosive ingestions occur most frequently in children younger than 6 years, with the majority of cases occurring in children between 12 and 48 months old. Corrosive ingestions remain a significant cause of paediatric morbidity (Kay and Wyllie 2009) but there are only 2.3% fatalities (Watson et al. 2005).
Table 7: Alkalis and acids frequently found in household products
The most common symptoms following a corrosive ingestion are dysphagia, drooling, feeding refusal, retrosternal pain, abdominal pain and vomiting. The presence of three or more symptoms is an important predictor of severe oesophageal burns.
Symptoms involving the airway are less common although dyspnea is associated with a high risk of significant gastrointestinal injury (Betalli et al. 2008). Severe symptoms and complications reported following a corrosive ingestion include haemolysis, disseminated intravascular coagulation, renal failure, liver failure, perforated viscera, peritonitis, mediastinitis and death.
Most accidents were due to ingestion of caustic alkaline substances and this is clearly attributable to the widespread domestic use of alkaline products. Bleach and caustic soda were the most frequent causes of accidents some years ago, but more recently, the incidence of accidents involving dishwasher powders, detergents and drain cleaners has increased.
Injury following ingestion is dependent on both the concentration and the pH of the agent. Tissue contact time, which is related to the physical corrosive properties, is also a determinant in the extent of injury (Salzman and O’Malley 2007). The corrosivity is primarily determined by the pH of the product/chemical but titratable alkalinity/acidity reserve, physical state (liquid/solid), viscosity, and concentration are also important (Lamireau et al. 2001). The ingestion of a strong alkali results in liquefaction necrosis, which is associated with deep penetration of the lining of the bowel and may result in perforation.
Alkalis are usually odourless and tasteless. This may result in consumption of a large volume in cases of accidental ingestion. Alkalis with a pH between 9 and 11, including many household detergents, rarely cause serious injury following ingestion. Ingestion of even small quantities of an alkali with a pH above 11 may cause severe burns (Vancura et al. 1980).
Acid ingestions represent approximately 15% of ingestion in children. Ingestion of strong acidic fluids with a pH of less than 3 have the highest risk for possible injury (Salzman and O’Malley 2007) and can result in coagulation necrosis. Liquids with a pH of less than 2 are considered to be extremely corrosive and have the greatest risk of injury (Waasdorp Hurtado and Kramer 2010). Their low viscosity and specific gravity result in rapid transit to the stomach, and gastric injury is more common than oesophageal injury, especially in the pre-pyloric area. Gastric injury following ingestion may result in gastric outlet obstruction or perforation frequently in the area of the gastric antrum or pilorous. Gastric perforation in association with an acid ingestion may be life threatening as frequently there is multivisceral organ injury and rapid clinical decompensation.
Because strong acids are very bitter, large-volume ingestion is limited to suicide attempts and rarely occurs accidentally. The volume of ingested material could not be accurately determined, although estimates from patients or witnesses ranged from 10 to 500 ml. If such acid corrosive chemicals were ingested accidentally, the amounts ingested were typically much smaller than alkaline chemicals as patients would recognize the unpleasant taste and stop drinking or vomit immediately (Tohda et al. 2008).
Source & ©:
SCCS,
and/or having child-
appealing properties,
(2011),
Annex IV: Toxicity of potential harmful ingredients,
pp. 42-47
The SCCS opinion states:
Essential oils have been used as a common cold remedy in medicine, as indoor air fresheners or conditioners in the household, for aromatherapy, in stain removers or other cleaning agents, in cosmetics, and also in industry, for example as a fat solvent.
The toxicity of individual essential oils varies. Lethal doses stated in the past were 50–500 mg/kg body weight. Recent toxicological data for this group is sparse, but certain oils (pine oil, wintergreen oil, camphor) have been identified in poisonings.
Pine Oil
Pine oil, a mixture of isomeric secondary and tertiary cyclic terpene alcohols, is a common component of cleaning solutions and is found in numerous household cleaning preparations. Its popularity stems from its disinfectant and deodorant properties as well as its ability to remove dirt and grease and its pleasant aroma. In addition, pine oil is reported to have a pleasant taste. Hydrocarbon ingestion (with pine oil and similar substances) accounted for 66,000 toxic exposures in 1997. Death due to pine oil ingestion was rare and was reported to be approximately 0.02% (two people). Both cases were the result of attempted suicide (Litovitz et al. 1988, Litovitz et al. 1998).
Particular concerns about ingestion of such solutions arise in the growing population of elderly and demented patients.
Pine oil has low viscosity and high volatility (Goldfrank 1994). The low viscosity of pine oil contributes to aspiration, while high volatility contributes to inhalation injury and asphyxiation. However, cleaning solutions contain additives that increase viscosity and decrease the volatility of pine oil, thus reducing its toxic risks.
Following ingestion or aspiration, pine oil is readily absorbed into the systemic circulation.
The systemic effects of pine oil primarily involve the central nervous system (CNS), gastrointestinal tract and respiratory systems (Ervin and Manske 1990). Within 90 minutes of clinically significant ingestions, most patients develop CNS depression and/or pneumonitis (Brook et al. 1989).
Wintergreen oil
Wintergreen oil is a strongly aromatic with a sweet woody odour. It is composed of methyl salicylate (approx. 98%) (Council of Europe 2006). Oil of Wintergreen may be used as a topical ointment or medicated oil for the relief of musculoskeletal pain and common colds (Botma et al. 2001, Chan 1996a). One teaspoon (5 ml) of Oil of Wintergreen is equivalent to approximately 7000 mg of salicylate or 21.7 adult aspirin tablets (Chan 1996b). Oil of Wintergreen is an important cause of salicylate poisoning in many western countries and has an appreciable morbidity and mortality (Gilman 1990).
Methyl salicylate is rapidly absorbed from the gastrointestinal tract. The onset of clinical symptoms is rapid, usually within 2 hours of ingestion, but salicylate blood levels can be detected as early as 15 minutes after ingestion (Liebelt and Shannon 1993). Clinical features are identical to those observed following poisoning with other salicylates. The major toxic effects may be grouped as gastrointestinal, neurological, haematological, metabolic and acid–base disturbances (Chan 1996a). Other systemic effects such as severe urticaria and angioedema following the use of methyl salicylate containing mints, toothpaste or liniments have been reported in patients with a past history of nasal allergy or aspirin hypersensitivity (Speer 1979). In salicylate poisoning, the dose ingested and the age of the patient are the most important factors determining the severity (Chan 1996b).
Generally, ingestion of salicylates at doses larger than 150 mg/kg body weight can produce toxic symptoms such as tinnitus, nausea, and vomiting. Salicylate sensitivity is a common adverse reaction to the methyl salicylate in oil of wintergreen; it can produce allergy-like symptoms or asthma. Ingestion of as little as 4 ml in a child can be fatal (Howrie et al. 1985).
Salicylates have also been linked with Reye’s syndrome in children and can cause retention of salt and water as well as acute reduction of renal function in patients with congestive heart failure or hypovolemia (Gilman et al. 1990).
Camphor
Camphor, originally a product from the bark of the camphor tree Cinnamommum camphora, is synthesized and is a common ingredient in many ointments. Toxicity usually results from oral ingestion, although there are reports of toxicity from dermal and inhalation exposure in a toddler. Signs and symptoms of camphor ingestion occur primarily as a result of its direct mucosal irritation and central nervous system (CNS) effects. Gastrointestinal effects include oropharyngeal irritation and burning with nausea and vomiting. Camphors’s CNS effects range from coma and apnea to agitation, anxiety, hallucinations, hyper-reflexia, myoclonic jerks, and seizures (Eldridge et al. 2007, Love et al. 2004).
Ingestion of 2g camphor generally produces dangerous effects in adults; ingestion of 0.7- 2.0 g camphor has proven fatal in children (Kauffman et al. 1994, Love et al. 2004). Seizures are a known complication of camphor toxicity and are reported after ingestion, inhalation, and dermal exposure. In 1982, after the reports of several incidents of camphor toxicity in young children, often involving camphorated oil products (20% camphor), the US Food and Drug Administration (FDA) limited the camphor content of common cold preparations to 11% and restricted the sale of camphorated oil (Khine et al. 2009). The Council of Europe recommended limiting the concentration of camphor in cosmetic products and a ban of camphor in cosmetic products for children below the age of 3 years (Council of Europe 2006).
Source & ©:
SCCS,
and/or having child-
appealing properties,
(2011),
Annex IV: Toxicity of potential harmful ingredients,
pp. 42-47
The SCCS opinion states:
Most detergents are formulated products containing surfactants which remove dirt, stains, and soil from surfaces or textiles. Surfactants consist of a hydrophobic and a hydrophilic component and have the ability to change the surface properties of water. Surfactants are grouped according to their ionic properties in water:
- Anionic surfactants have a negative charge;
- Non-ionic surfactants have no charge;
- Cationic surfactants have a positive charge;
- and Amphoteric surfactants have positive or negative charge dependent on pH.
Surfactants have low oral acute toxicity. In general, surfactants have an irritating effect on mucous membranes. Foaming is the predominant problem. Manifestations may also include vomiting, abdominal pain, flatulence and diarrhoea. In rare cases, vomiting or formation of considerable amounts of foam in the mouth involve an aspiration risk. Aspiration may have taken place if a persistent cough and respiratory complaints are observed. For healthy children and adults, ingredients containing surfactants such as shower gels, bubble baths, shampoos, all-purpose cleansers or liquid detergents do not pose a particular risk. But they may be life threatening or even fatal for elderly persons because they are more prone to foam aspiration after vomiting, which may result in severe pulmonary manifestations and a fatal outcome (Hahn et al. 2008).
The toxicity studies performed with animals show that, in general, surfactants are of low toxicity.
Anionic surfactants (AS) are readily absorbed from the gastrointestinal tract after oral administration. AS are extensively metabolized in various species resulting in the formation of several metabolites. The major site of metabolism is the liver (Gloxhuber and Künstler 1992, IPCS 1996). The acute toxicity of AS in animals is considered to be low after skin contact or oral intake.
Non-ionic surfactants are widely used in consumer products such as laundry detergents, cleaning and dishwashing agents, and personal care products. By volume, the most important non-ionic surfactants are included in the very versatile group of alcohol ethoxylates (AE) and alcohol alkoxylates (AA).
AE are used in many types of consumer and industrial products such as laundry detergents, all-purpose cleaning agents, dishwashing agents, emulsifiers, and wetting agents. AA are used as weakly foaming and foam-mitigating surfactants in household cleaning agents, dishwashing agents and cleaning agents designed for the food industry (Bertleff et al. 1997). In general, AE are readily absorbed through the gastrointestinal mucosa of rats. AE are quickly eliminated from the body through the urine, faeces, and expired air (CIRP 1983, SFT 1991). The LD50 values after oral administration to rats range from about 1-15 g/kg body weight indicating a low to moderate acute toxicity.
By volume, the most important cationic surfactants in household products are the alkyl ester ammonium salts that are used in fabric softeners. Alkyltrimethylammonium chlorides (ATMAC) and, to a minor extent, alkyltrimethylammonium bromides (ATMAB) are primarily used in cosmetic products including hair conditioners, hair dyes and colours, and other hair and personal care preparations. Studies after oral administration showed that only small amounts were found in the urine and in the blood plasma, indicating poor intestinal absorption (Isomaa 1975).
The acute oral toxicity of alkyltrimethylammonium salts is somewhat higher than the toxicity of anionic and non-ionic surfactants. This may be due to the strongly irritating effect which cationic surfactants exhibit on the mucous membrane of the gastrointestinal tract (SFT 1991). Dialkyldimethylammonium chlorides (DADMAC) are used as antistatic agents in cosmetic products including hair conditioners and hair colouring preparations and as biocides in industrial and household cleaning agents. No specific data describing the health effects of dialkyldimethylammonium salts were obtained. However, many of the properties described for alkyltrimethylammonium salts also apply to dialkyldimethylammonium salts, although these are generally less irritating than the corresponding alkyltrimethylammonium salts (CIRP 1997).
Alkyldimethylbenzylammonium chlorides (ADMBAC) and bromides (ADMBAB) are used in cosmetic products including hair conditioners and hair colouring preparations. Besides being surfactants and antistatic agents, the alkyldimethylbenzylammonium compounds function as biocides in various cosmetic and detergent products. The biocidal properties are utilized, when ADMBAC are added to all-purpose or specialized cleaning agents. No specific toxicokinetic studies were identified for ADMBAC. Different homologues of ADMBAC showed a moderate acute toxicity in experiments with rats and mice (CIRP 1989, Zeiger et al. 1987).
ADMBAC are included in Annex I of the list of dangerous substances of Council Directive 67/548/EEC with the following classification: C8-18 ADMBAC are classified as Harmful with the risk phrases R21/22 (Harmful in contact with skin and if swallowed) and Corrosive (C) with R34 (Causes burns).
Amphoteric surfactants are surface-active compounds with both acidic and alkaline properties and include two main groups, i.e. betaines and real amphoteric surfactants based on fatty alkyl imidazolines. Amphoteric surfactants are used in personal care products (e.g. hair shampoos and conditioners, liquid soaps, and cleansing lotions) and in all-purpose and industrial cleaning agents.
Betaines are primarily used in personal care products such as hair shampoos, liquid soaps, and cleansing lotions. Other applications include all-purpose cleaning agents, hand dishwashing agents, and special textile detergents. Amphoteric surfactants are easily absorbed in the intestine and are excreted partly unchanged via the faeces without being accumulated in the organism (SFT 1991). Betaines generally have a low acute toxicity, e.g. LD50 values for cocoamidopropylbetain (30% solution) by oral administration have been determined to 4,910 mg/kg body weight in rats (CIRP 1991).
Source & ©:
SCCS,
and/or having child-
appealing properties,
(2011),
Annex IV: Toxicity of potential harmful ingredients,
pp. 42-47
The SCCS opinion states:
Alcohols are used as solvents in cosmetic and household detergents. Short chain alcohols are used in liquid laundry detergents and liquid dishwashing agents in order to ensure solubility and stability of the products.
Ethanol is added to mouthwash to make non-polar ingredients such as essential oils water- soluble and to kill bacteria associated with bad breath and plaque formation.
Mouthwashes have great potential to be overingested by children because they are made to look enticing, taste good, and are present in most homes. Although fatalities from ethanol- containing mouthwash are rare, ingestion by children occurs frequently, sometimes leading to nonlethal but toxic reactions (Massey and Schulman 2006). Mouthwashes contain denaturants (generally minimally toxic bittering agents) to discourage consumption. Children can ingest large amounts of mouthwash (from big containers) for their body weight and achieve high blood-ethanol levels very quickly (Massey and Schulman 2006). This is particularly true for the American market where mouthwashes may be sold in large containers, up to 2 litres.
Most serious cases of poisoning involve ingestion of large quantities of products containing a lower concentration of ethanol, for example, mouthwash, rather than the ingestion of concentrated solutions, which are more irritant (Riordan et al. 2002).
Children who have ingested the equivalent of 0.4 ml/kg pure ethanol should be observed for 4 hours. Ingestion of 1.2 ml/kg pure ethanol requires hospital admission (Riordan et al. 2002). Symptoms of ethanol toxicity vary with blood concentration, which is a function of the quantity ingested, ingestion rate, body weight and the individual’s physiological tolerance to ethanol. The lethal dose of ethanol for adults is 5-8 g/kg body weight (Massey and Schulman 2006). Children exhibit many of the same symptoms as adults but irritability is often the first noticeable sign of acute ethanol toxicity (Massey and Schulman 2006). The lethal dose of ethanol for children is 3 g/kg body weight (Massey and Schulman 2006) and doses as small as 0.6 g/kg body weight have been seen to induce toxic reactions in a small child (Massey and Schulman 2006).
Isopropanol
Isopropanol is about twice as toxic as ethanol, although it generally has a low acute toxicity as measured by its oral rat LD50 of 5,000 mg/kg. It increases the toxicity of chlorinated solvents if exposure occurs simultaneously (HSDB 1999).
Ingestion of bittering agents
The use of bittering agents as “aversives” has been advocated as a possible method of preventing toxic ingestions by children. The most commonly recommended agent denatonium benzoate (Bitrex) was found to have an unpleasant and bitter taste at concentrations as low as 50 ppb in liquid products (Berning et al. 1982, Hansen et al 1993, Lawless et al. 1982, Payne 1988, Silbert and Frude 1991). Acute toxicity of the aversive agents does not appear to be a major issue. Many of the bittering agents, including sucrose octaacetate and denatonium benzoate, have a low toxicity at levels used for aversion. However, none of these agents have a complete toxicity profile (USCPSC 2002). Rodgers and Tenenbein (1994) reviewed the published data on efficacy and toxicity of denatonium benzoate when used in cleaning products etc. and concluded that denatonium benzoate seems to be safe when used at low concentrations.
Sucrose octaacetate (SOA) is also used as an alcohol denaturant. Although higher concentrations of SOA are needed for bitterness compared to denatonium salts (10 ppm of SOA versus 0.05 ppm for denatonium benzoate), the toxicity of SOA is very low. Acute toxicity studies conducted with rats and rabbits failed to estimate a lethal dose; an oral dose as high as 45 g/kg produced no-compound-related adverse effects.
Source & ©:
SCCS,
and/or having child-
appealing properties,
(2011),
Annex IV: Toxicity of potential harmful ingredients,
pp. 42-47
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