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Skin sensitization and possible groupings for 'read across' for rosin based substances
H P A Illing1, T Malmfors, L Rodenburg
1PICS Ltd, Sherwood, Brimstage Road, Heswall, Wirral CH60 1XE, UK. paul@sherwood37.demon.co.uk
Regulatory Toxicology and Pharmacology : RTP
|May 5, 2009
Summary
Chemically modified rosin resins were tested for skin sensitization. Acid anhydrides formed from reactions with fumaric or maleic acid are strong sensitizers, while esterification can reduce or eliminate this potential.
Area of Science:
- Toxicology
- Dermatology
- Chemical Engineering
Background:
- Rosin resins are widely used in various industrial applications.
- Skin sensitization potential of modified rosin resins requires thorough evaluation for regulatory compliance.
- Existing data from Guinea Pig Maximization Test (GPMT) provides a basis for comparison.
Purpose of the Study:
- To assess the skin sensitization potential of chemically modified rosin resins using the mouse Local Lymph Node Assay (LLNA).
- To compare LLNA results with existing GPMT data.
- To evaluate the impact of chemical modifications (e.g., esterification, reactions with fumaric/maleic acid) on rosin resin sensitization.
Main Methods:
- Mouse Local Lymph Node Assay (LLNA) was employed to determine sensitization potential.
- Comparative analysis of LLNA data with historical GPMT results.
- Chemical modifications included reactions with fumaric acid, maleic anhydride, and esterification.
Main Results:
- Maleopimaric acid anhydride, formed from reactions with sufficient fumaric or maleic acid, is a strong skin sensitizer.
- Esterification of acid anhydrides generally deactivates sensitization potential.
- Esterified maleinated/fumarated rosin showed marginal sensitization, potentially due to increased solubility.
- Gum rosin esterified with pentaerythritol, decarboxylated rosin, glycerol ester of tall oil rosin, and rosin polymers were not classifiable as sensitizers.
Conclusions:
- The study confirms the utility of grouping substances for 'read across' approaches, aligning with US EPA High Production Volume (HPV) Challenge Program groupings.
- Chemical modification significantly influences the skin sensitization potential of rosin resins.
- Meeting current EU regulatory criteria for skin sensitization assessment of rosin-related substances presents scientific challenges.
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