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1004715 
Journal Article 
Final report on the safety assessment of melamine/formaldehyde resin 
Pang, SNJ 
1995 
Yes 
Journal of the American College of Toxicology
ISSN: 0730-0913 
14 
373-385 
English 
Melamine/Formaldehyde Resin is intended for use as a film former in cosmetic formulations, but there are no current uses reported. Respiratory distress, bleeding in the lungs, significant weight loss, and macrophage influx into the alveoli were observed during inhalation studies in rats. A 2-year chronic feeding study in rats at concentrations ≥ 10% produced little toxicity. Similar results were found in dogs at concentrations of 2.5, 3, and 5%. Reproductive toxicity was evaluated in rats through two generations with no evidence of reproductive effects. Case reports in the clinical literature have reported sensitization to Melamine/Formaldehyde Resin, not all of which were attributed to the presence of formaldehyde. Available data on melamine were reviewed. No irritation or sensitization was produced by 1% (aqueous) melamine in guinea pigs. In an oral carcinogenesis assay in male rats, melamine caused transitional-cell carcinomas of the urinary bladder, but produced no tumors in female rats. Adverse effects of formaldehyde were summarized from an earlier review of that ingredient by the Cosmetic Ingredient Review. The adverse effects included respiratory damage, skin irritation and sensitization, and carcinogenesis. The available data were insufficient to support the safety of Melamine/Formaldehyde Resin. Additional data were considered necessary in order to evaluate the safety of this ingredient, including chemical and physical data (such as p H), amount of free formaldehyde as a function of p H, and the aqueous or alcohol vehicle used; impurities (or purity); physical form of the ingredient as it would be used; UV absorption data (if the ingredient absorbs in the UVB or UVA regions of the electromagnetic spectrum, photosensitization studies would be needed); 28-day dermal toxicity tests; and human irritation and sensitization. It cannot be concluded that this ingredient is safe for use in cosmetic products until the listed safety data have been obtained and evaluated. 
• Formaldehyde [archived]
     Prior to 2013 Search
     Animal UR Cancer studies
          Cited
     UR Cancer MOA
          Cited
     Nervous system effects
          Found
               Database search results
                    Web of Science
     Pulmonary Function
          Found
          Screened
               Title/Abstract Screen
                    Review/Reports
     Reproductive and Developmental Effects
          Screened
               Title/abstract
                    Mixtures
          Cited
     Sensory Irritation
          Found
          Screened
               Human
                    Not about Formaldehyde
     Animal Non-Cancer Respiratory Pathology
          Excluded due to title screening
               Formaldehyde not test agent or part of mixture
     Immune Section
          Reviews and reports
          No abstract
     Inflammation/Reactive Oxygen Species
          WOS
          Toxline
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               Not Primary Study: Review, Commentary, Abstract, Policy, Current Practice, Workplace Assessment
     Retroactive RIS import
          Pre2013
               Merged Litsearch Results 100912
               Merged LitSearch Results ToxNet 101012
               Review Article Screen 100912
               Review Article Screen ToxNet 101012
               Web of Science Search 100412
               Animal non-cancer respiratory pathology Pre2013 search
                    Excluded due to title/abstract screening
                         Not Formaldehyde
          2013
               HCHON tox Ref Identification 022713
               HERO Formaldehyde Immune Section 20Mar2013
               Lit Tags Pulm Func 091613
                    Report
               Irritation- Pubmed WOS Sorted
                    Human
                         Not about Formaldehyde
          2014
               HERO_Formaldehyde_InflammationReactiveOxygenSpecies_pid_31_uid_5713Sorting091214
               Formaldehyde_Irritation_102814
                    Human
                         Not About Formaldehyde
               HERO_Formaldehyde_InflammationReactiveOxygenSpecies_pid_31_uid_5713
                    Screened (Title/Abstract)
                         Not Primary Study: Review, Commentary, Abstract, Policy, Current Practice, Workplace Assessment, etc
               Immune_HERO_allyr
          2015
               FA DevRepro 072115
                    Mixtures-Exposure Criteria
• IRIS Formaldehyde (Inhalation) [Final 2024]
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          Other sources and cited references
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          Pulmonary Function in Humans
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          Respiratory Tract Pathology in Animals
               Excluded
          Immune-Mediated Conditions in Humans, Including Asthma and Allergy
               Excluded
          Nervous System Effects
               Excluded
          Reproductive and Developmental Effects
               Excluded
          Inflammation and Immune-Related Mechanistic Studies
               Excluded