RIFM fragrance ingredient safety assessment, p-tolualdehyde, CAS Registry Number 104-87-0

Area of Science:

• Chemical safety assessment
• Toxicology
• Environmental risk evaluation

Background:

• p-Tolualdehyde is a chemical compound requiring safety evaluation for various endpoints.
• Existing data and read-across approaches are utilized to assess its safety profile.
• Regulatory compliance and consumer safety are key drivers for such assessments.

Purpose of the Study:

• To evaluate the safety of p-tolualdehyde for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, and environmental impact.
• To determine if p-tolualdehyde poses risks to human health and the environment based on toxicological and exposure data.
• To support the continued use of p-tolualdehyde based on a comprehensive safety assessment.

Main Methods:

• Utilized read-across data from analogs benzaldehyde, cuminaldehyde, and 4-ethylbenzaldehyde for genotoxicity, skin sensitization, and phototoxicity assessments, respectively.
• Applied the threshold of toxicological concern (TTC) for Cramer Class I materials to evaluate repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity.
• Assessed environmental safety by evaluating persistence, bioaccumulation, and toxicity (PBT) criteria and calculating risk quotients (Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]).

Main Results:

• p-Tolualdehyde is not expected to be genotoxic based on benzaldehyde data.
• A No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm² was determined for skin sensitization using cuminaldehyde data.
• Exposure levels for repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity were found to be below the TTC.
• p-Tolualdehyde is not expected to be phototoxic or photoallergenic, based on 4-ethylbenzaldehyde data.
• p-Tolualdehyde is not persistent, bioaccumulative, and toxic (PBT) and has environmental risk quotients <1 in Europe and North America.

Conclusions:

• The safety assessment supports the use of p-tolualdehyde as described.
• p-Tolualdehyde demonstrates a favorable safety profile across key toxicological and environmental endpoints.
• The evaluated risks are considered acceptable, supporting its continued application.