Skin Sensitization Potential of Trisodium Ethylenediaminetetraacetate

Henck, Judith W.; Lockwood, Doreen D.; Olson, Kenneth J.

doi:10.3109/01480548009017836

Cited by 6 publications

(2 citation statements)

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“…The guinea pigs had no signs of allergic reactions (Yang and Chan 1964). Henck, Lockwood, and Olson (1980) determined the skin sensitization potentials of Trisodium EDTA and ethylenediamine in a study using male Hartley guinea pigs (10/group). The positive control was the diglycidyl ether of 2,2-di(p,p 0hydroxyphenyl)propane.…”

Section: Skin Irritation and Sensitizationmentioning

confidence: 99%

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

2002

Int J Toxicol

102

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EDTA (ethylenediamine tetraacetic acid) and its salts are substituted diamines. HEDTA (hydroxyethyl ethylenediamine triacetic acid) and its trisodium salt are substituted amines. These ingredients function as chelating agents in cosmetic formulations. The typical concentration of use of EDTA is less than 2%, with the other salts in current use at even lower concentrations. The lowest dose reported to cause a toxic effect in animals was 750 mg/kg/day. These chelating agents are cytotoxic and weakly genotoxic, but not carcinogenic. Oral exposures to EDTA produced adverse reproductive and developmental effects in animals. Clinical tests reported no absorption of an EDTA salt through the skin. These ingredients are likely, however, to affect the passage of other chemicals into the skin because they will chelate calcium. Exposure to EDTA in most cosmetic formulations, therefore, would produce systemic exposure levels well below those seen to be toxic in oral dosing studies. Exposure to EDTA in cosmetic formulations that may be inhaled, however, was a concern. An exposure assessment done using conservative assumptions predicted that the maximum EDTA dose via inhalation of an aerosolized cosmetic formulation is below that shown to produce reproductive or developmental toxicity. Because of the potential to increase the penetration of other chemicals, formulators should continue to be aware of this when combining these ingredients with ingredients that previously have been determined to be safe, primarily because they were not significantly absorbed. Based on the available data, the Cosmetic Ingredient Review Expert Panel found that these ingredients are safe as used in cosmetic formulations.

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Section: Skin Irritation and Sensitizationmentioning

confidence: 99%

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

2002

Int J Toxicol

102

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“…Ethylene diamine is recognized at causing sensitization in humans (Erminero et al, 1968;Valeeva et al, 1979;Wuethrich, 1972). A positive sensitization response has also been seen in animal experiments (Thorgeirsson, 1978;Maurer et al, 1979;Henck et al, 1980). Sensitization was not seen following repeated dermal exposure of hexamethylene diamine (HMDA) to guinea pigs, although the material was irritating (Zeller, 1957).…”

Section: Discussionmentioning

confidence: 84%

Inhalation Toxicology of Fumed Dodecanediamine

Valentine

Frame

Kennedy

2004

Inhalation Toxicology

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Dodecanediamine (DDDA) is used in the production of specialty polymers. Exposure to this chemical was associated with dermal sensitization in pilot-plant workers, and the possibility that the chemical could produce dermal sensitization was confirmed in a guinea pig test. This property and its dermal irritative properties demonstrate the need to limit skin contact. The possibility of exposure via inhalation also exists. Although stable under ambient conditions, DDDA is processed at elevated temperatures where it may fume, forming a carbamate after reaction with atmospheric carbon dioxide. Some of the carbamate may be converted back to the diamine after hydrolysis in tissue. The rat was used to evaluate the effects of both acute and repeated exposure following inhalation. Fumed DDDA was found to be moderately toxic following a single 4-h exposure with lethality seen at concentrations of 680 mg/m3 or higher. Rats were then exposed to concentrations of either 0 (control), 11, 34, or 98 mg fumed DDDA/m3, 6 h/day, 5 days/wk for 2 wk. Mortality was seen at the highest concentrations, along with increased lung weights. In these rats, laryngeal and tracheal lesions consisting of acute necrosis and inflammation were seen, but surviving rats given a 14-day recovery period showed almost complete recovery. Tracheal and laryngeal lesions were not seen in rats exposed to either 11 or 34 mg/m3. Degenerative and necrotizing lesions were seen in the nasal regions, primarily the respiratory mucosa, of rats in all three treatment groups. The lesions were exposure related with regard to incidence and severity, but regeneration was seen following the recovery period. No evidence of systemic toxicity was seen. The dose-response characteristics of the nasal lesions and the sensitization potential suggest that workplace control levels of 0.1 mg/m3 should be sufficient to protect workers against the untoward effects of fumed DDDA.

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Ethylenediaminetetraacetic Acid and Related Chelating Agents

Hart¹

2000

Ullmann's Encyclopedia of Industrial Chemistry

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Skin Sensitization Potential of Trisodium Ethylenediaminetetraacetate

Cited by 6 publications

References 1 publication

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

Inhalation Toxicology of Fumed Dodecanediamine

Ethylenediaminetetraacetic Acid and Related Chelating Agents

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