RIFM Natural Complex Substance (NCS) fragrance ingredient safety assessment, clove bud absolute, CAS Registry Number...

Area of Science:

• Toxicology
• Environmental Safety
• Dermatology

Background:

• Clove bud absolute is a widely used ingredient in various consumer products.
• Comprehensive safety assessments are crucial for ingredients used in fragrances and cosmetics.
• Evaluating potential risks associated with ingredient exposure is a regulatory requirement.

Purpose of the Study:

• To conduct a thorough safety evaluation of clove bud absolute.
• To assess genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety.
• To determine safe usage conditions for clove bud absolute.

Main Methods:

• Component analysis of clove bud absolute.
• Utilizing target data, read-across data, and Threshold of Toxicological Concern (TTC) for toxicity endpoints.
• Evaluating photoirritation and photoallergenicity using ultraviolet/visible (UV/Vis) absorption spectra.
• Assessing environmental safety based on IFRA Environmental Standards for Persistent, Bioaccumulative, and Toxic (PBT) or (very) Persistent, (very) Bioaccumulative (vPvB) components.

Main Results:

• No genotoxicity concerns were identified for the components of clove bud absolute.
• Clove bud absolute is deemed safe for repeated dose and reproductive toxicity under specified conditions.
• No concerns for skin sensitization were found at current usage levels.
• Clove bud absolute is not expected to be photoirritating or photoallergenic.
• Inhalation exposure is below the established TTC, indicating no local respiratory toxicity risk.
• No PBT or vPvB components were detected, and no risk to the aquatic environment is anticipated.

Conclusions:

• Clove bud absolute is safe for use in consumer products based on the evaluated toxicological and environmental endpoints.
• The safety assessment supports the use of clove bud absolute under the described conditions.
• The ingredient poses no significant risk to human health or the environment.