The irritative property of alpha-tricalcium phosphate to the rabbit skin
Abstract
The aim of this study was to assess the irritant properties of a new developed calcium phosphate ceramic, alpha-tricalcium phosphate (alpha-TCP) after single application to intact skin of the rabbit. The test substance, alpha-TCP was produced by modified hydrothermal method and prepared in two different forms, as a solid material (disc 5 x 2 mm) and paste. Both, solid material and paste of alpha-TCP were evaluated for primary skin irritation to the ISO 10993-10:2002/Amd 1:2006 Biological Evaluation of Medical Devices - Part 10. At the end of the study macroscopic examination of the skin was performed. In this model, general and local tolerances were good. Score of primary irritation (SPI) and primary irritation index (PII) of alpha-TCP for both, solid material and paste, revealed that there was no significant toxicity/irritability (PII = 0.0) as compared to the negative control (PII = 0.0). Positive control did cause significant skin irritation in acute irritation test using Draize tec...hnique in rabbit model (PII = 2.11). Based on present results, it can be concluded that the the irritation potential of the tested material is negligible. However, other procedures for preclinical safety assessments of the alpha-TCP material are needed in order to completely elucidate its toxic potential.
Keywords:
Biocompatibility / Calcium phosphate ceramics / Skin irritation testSource:
General Physiology and Biophysics, 2009, 28, 168-173Publisher:
- General Physiol And Biophysics, Bratislava
Funding / projects:
- Ministry of Science and Technological Development, Serbia [E3033]
Institution/Community
Tehnološko-metalurški fakultetTY - JOUR AU - Kojić, Zvezdana AU - Stojanović, Dobrica AU - Popadić, Svetlana AU - Jokanović, Milan AU - Janaćković, Đorđe PY - 2009 UR - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/1491 AB - The aim of this study was to assess the irritant properties of a new developed calcium phosphate ceramic, alpha-tricalcium phosphate (alpha-TCP) after single application to intact skin of the rabbit. The test substance, alpha-TCP was produced by modified hydrothermal method and prepared in two different forms, as a solid material (disc 5 x 2 mm) and paste. Both, solid material and paste of alpha-TCP were evaluated for primary skin irritation to the ISO 10993-10:2002/Amd 1:2006 Biological Evaluation of Medical Devices - Part 10. At the end of the study macroscopic examination of the skin was performed. In this model, general and local tolerances were good. Score of primary irritation (SPI) and primary irritation index (PII) of alpha-TCP for both, solid material and paste, revealed that there was no significant toxicity/irritability (PII = 0.0) as compared to the negative control (PII = 0.0). Positive control did cause significant skin irritation in acute irritation test using Draize technique in rabbit model (PII = 2.11). Based on present results, it can be concluded that the the irritation potential of the tested material is negligible. However, other procedures for preclinical safety assessments of the alpha-TCP material are needed in order to completely elucidate its toxic potential. PB - General Physiol And Biophysics, Bratislava T2 - General Physiology and Biophysics T1 - The irritative property of alpha-tricalcium phosphate to the rabbit skin EP - 173 SP - 168 VL - 28 UR - conv_2391 ER -
@article{ author = "Kojić, Zvezdana and Stojanović, Dobrica and Popadić, Svetlana and Jokanović, Milan and Janaćković, Đorđe", year = "2009", abstract = "The aim of this study was to assess the irritant properties of a new developed calcium phosphate ceramic, alpha-tricalcium phosphate (alpha-TCP) after single application to intact skin of the rabbit. The test substance, alpha-TCP was produced by modified hydrothermal method and prepared in two different forms, as a solid material (disc 5 x 2 mm) and paste. Both, solid material and paste of alpha-TCP were evaluated for primary skin irritation to the ISO 10993-10:2002/Amd 1:2006 Biological Evaluation of Medical Devices - Part 10. At the end of the study macroscopic examination of the skin was performed. In this model, general and local tolerances were good. Score of primary irritation (SPI) and primary irritation index (PII) of alpha-TCP for both, solid material and paste, revealed that there was no significant toxicity/irritability (PII = 0.0) as compared to the negative control (PII = 0.0). Positive control did cause significant skin irritation in acute irritation test using Draize technique in rabbit model (PII = 2.11). Based on present results, it can be concluded that the the irritation potential of the tested material is negligible. However, other procedures for preclinical safety assessments of the alpha-TCP material are needed in order to completely elucidate its toxic potential.", publisher = "General Physiol And Biophysics, Bratislava", journal = "General Physiology and Biophysics", title = "The irritative property of alpha-tricalcium phosphate to the rabbit skin", pages = "173-168", volume = "28", url = "conv_2391" }
Kojić, Z., Stojanović, D., Popadić, S., Jokanović, M.,& Janaćković, Đ.. (2009). The irritative property of alpha-tricalcium phosphate to the rabbit skin. in General Physiology and Biophysics General Physiol And Biophysics, Bratislava., 28, 168-173. conv_2391
Kojić Z, Stojanović D, Popadić S, Jokanović M, Janaćković Đ. The irritative property of alpha-tricalcium phosphate to the rabbit skin. in General Physiology and Biophysics. 2009;28:168-173. conv_2391 .
Kojić, Zvezdana, Stojanović, Dobrica, Popadić, Svetlana, Jokanović, Milan, Janaćković, Đorđe, "The irritative property of alpha-tricalcium phosphate to the rabbit skin" in General Physiology and Biophysics, 28 (2009):168-173, conv_2391 .