Italy has concluded its evaluation of 1-phenylethanol (EC 202-707-1, CAS 98-85-1), a substance commonly used in consumer and industrial products, under the REACH regulation. The evaluation, finalised in September 2024, highlights health concerns, particularly regarding carcinogenicity and eye irritation, raising the need for harmonised classification across the EU.
Widespread Industrial and Consumer Use
1-Phenylethanol is a versatile chemical used across various sectors. It is primarily found in:
- Cleaning products: including washing agents and polishes used in households and by professional workers.
- Fragrances and perfumes: where it acts as a fragrance component in personal care products and cosmetics.
- Pharmaceuticals: used as a chiral building block for the synthesis of active pharmaceutical ingredients.
- Cosmetics and personal care products: widely used in skin and hair care products, air fresheners, and other scented items.
- Air care products: released from items like scented candles, toys, and paper products.
In addition to consumer use, 1-phenylethanol plays a significant role in industrial applications, where it is employed in the manufacture of chemicals, as well as in health services and formulation processes.
Health and Environmental Concerns
Selected for substance evaluation under the Community Rolling Action Plan (CoRAP) in 2019 due to its wide use and potential risks, 1-phenylethanol was evaluated for carcinogenic and mutagenic properties, as well as its impact on workers and the environment. Its presence in products used by consumers and professional workers increases the likelihood of direct exposure, particularly through skin contact and inhalation.
Carcinogenicity and Acute Toxicity Confirmed
A study conducted by the National Institute of Health in Italy confirmed that 1-phenylethanol could be classified as a Category 2 carcinogen. The findings are based on evidence of kidney adenomas and adenocarcinomas in male rats during oral testing. Additionally, the chemical displayed acute toxicity, falling into Category 4 based on lethal doses in animal studies.
Eye Irritation and Repeated Exposure Risks
Besides its carcinogenic potential, 1-phenylethanol was confirmed to cause eye irritation, leading to its classification under Category 2. Studies on repeated exposure in rats demonstrated signs of liver toxicity, suggesting its classification as STOT RE 2 (Specific Target Organ Toxicity – Repeated Exposure), particularly affecting the liver.
Regulatory Implications and Follow-Up
As a result of the evaluation, Italy has proposed harmonised classification and labelling for 1-phenylethanol across the EU. The following classifications are recommended:
- Carcinogenicity, Category 2
- Acute Toxicity, Category 4
- Eye Irritation, Category 2
- STOT RE 2 (Liver)
Although no immediate restrictions are planned, the substance remains under observation, with the possibility of further regulatory risk management if new data confirms additional concerns.
