Toxicological studies on 2,4,6-tribromoanisole

Area of Science:

• Toxicology
• Chemical Safety
• Risk Assessment

Background:

• 2,4,6-tribromoanisole (TBA) is a flame retardant and antifungal agent.
• TBA can impart an undesirable odor to packaging, raising consumer concerns about product safety.
• Evaluating the oral toxicity of TBA is crucial for assessing human ingestion risks.

Purpose of the Study:

• To assess the oral toxicity and safety of 2,4,6-tribromoanisole (TBA) in rats.
• To determine if TBA is mutagenic using a bacterial reverse mutation assay.
• To establish a No Observed Adverse Effect Level (NOAEL) for oral TBA exposure.

Main Methods:

• Conducted bacterial reverse mutation studies to assess mutagenicity.
• Performed single and repeated dose oral toxicity studies (5-day and 28-day) in rats.
• Administered TBA via oral gavage at various dose levels, monitoring for adverse effects, body weight, food consumption, clinical signs, hematology, and clinical biochemistry.

Main Results:

• TBA was confirmed as non-mutagenic in the bacterial reverse mutation study.
• No deaths or significant adverse effects were observed in single or repeated dose studies, except for male rat-specific findings at high doses.
• Male rat-specific findings included hyaline droplet nephropathy and liver hypertrophy, considered not relevant for human risk assessment.
• High TBA bioavailability was detected in plasma, dose-dependently.

Conclusions:

• Oral administration of TBA to rats did not result in significant toxicity relevant to human risk assessment.
• The No Observed Adverse Effect Level (NOAEL) for the 28-day oral study in rats was determined to be 1000 mg/kg body weight/day.
• TBA is considered safe for oral ingestion at levels below the established NOAEL.