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Evaluación de la seguridad de los ingredientes de fragancias RIFM, eicosano, Registro CAS Número 112-95-8
A M Api1, A Bartlett1, D Belsito2
1Research Institute for Fragrance Materials, Inc., 1200 MacArthur Boulevard, Suite 306, Mahwah, NJ 07430, USA.
Resumen
Eicosane es seguro para su uso, no muestra genotoxicidad o riesgos significativos en las evaluaciones de toxicidad, sensibilización o impacto ambiental. Los márgenes de seguridad superan los 100 para los principales parámetros de toxicidad, lo que confirma su perfil de seguridad.
Área de la Ciencia:
- Toxicología Toxicología.
- Seguridad Ambiental Seguridad Ambiental
- Evaluación de la seguridad química.
Sus antecedentes:
- El eicosano es un alcano de cadena larga con varias aplicaciones industriales.
- Las evaluaciones integrales de seguridad son cruciales para comprender los posibles impactos en la salud humana y el medio ambiente.
Objetivo del estudio:
- Para evaluar la genotoxicidad, la toxicidad por dosis repetidas, la toxicidad reproductiva, la toxicidad respiratoria local, la fotoirritación / fotoalergenicidad, la sensibilización de la piel y la seguridad ambiental del eicosano.
- Para determinar si el eicosano plantea problemas de seguridad bajo sus niveles de uso declarados actuales.
Principales métodos:
- Utilizó datos de lectura transversal de análogos como heneicosano, undecano y cera de parafina para los puntos finales de toxicidad.
- Fotoirritación/fotoalergenicidad evaluada basada en el análisis estructural de los cromóforos.
- Se evaluó la toxicidad respiratoria local utilizando el umbral de preocupación toxicológica (TTC).
- Determinación de la seguridad ambiental mediante la evaluación de los criterios de persistencia, bioacumulación y toxicidad (PBT) y el cálculo de los coeficientes de riesgo (RQ).
Principales resultados:
- El eicosano no demostró genotoxicidad.
- Los márgenes de exposición (MOE) superaron los 100 para la dosis repetida y la toxicidad reproductiva a través de la lectura cruzada.
- No se identificaron problemas de seguridad para la sensibilización de la piel.
- El eicosano carece de un cromóforo, lo que indica que no hay riesgo de fotoirritación o fotoalergenicidad.
- La exposición respiratoria local está por debajo del TTC.
- El eicosano no es persistente, bioacumulativo y tóxico (PBT), con RQs <1 en las principales regiones del mundo.
Conclusiones:
- El eicosano no es genotóxico y no presenta preocupaciones significativas de seguridad por dosis repetidas o toxicidad reproductiva.
- La sustancia no es un fotoirritante o fotosensibilizante y no plantea ningún riesgo de sensibilización de la piel.
- Las evaluaciones de riesgos ambientales confirman que el eicosano no es PBT y tiene un impacto ambiental insignificante en los volúmenes de uso actuales.
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