scholarly journals The Chemical UV-Filter 3-Benzylidene Camphor Causes an Oestrogenic Effect in an in vivo Fish Assay

2008 ◽  
Vol 91 (4) ◽  
pp. 204-208
Author(s):  
Henrik Holbech ◽  
Ulrik Nørum ◽  
Bodil Korsgaard ◽  
Poul Bjerregaard
Keyword(s):  
1998 ◽  
Vol 26 (5) ◽  
pp. 679-708 ◽  
Author(s):  
Horst Spielmann ◽  
Michael Balls ◽  
Jack Dupuis ◽  
Wolfgang J. W. Pape ◽  
Odile de Silva ◽  
...  

In 1996, the Scientific Committee on Cosmetology of DGXXIV of the European Commission asked the European Centre for the Validation of Alternative Methods to test eight UV filter chemicals from the 1995 edition of Annex VII of Directive 76/768/EEC in a blind trial in the in vitro 3T3 cell neutral red uptake phototoxicity (3T3 NRU PT) test, which had been scientifically validated between 1992 and 1996. Since all the UV filter chemicals on the positive list of EU Directive 76/768/EEC have been shown not to be phototoxic in vivo in humans under use conditions, only negative effects would be expected in the 3T3 NRU PT test. To balance the number of positive and negative chemicals, ten phototoxic and ten non-phototoxic chemicals were tested under blind conditions in four laboratories. Moreover, to assess the optimum concentration range for testing, information was provided on appropriate solvents and on the solubility of the coded chemicals. In this study, the phototoxic potential of test chemicals was evaluated in a prediction model in which either the Photoirritation Factor (PIF) or the Mean Photo Effect (MPE) were determined. The results obtained with both PIF and MPE were highly reproducible in the four laboratories, and the correlation between in vitro and in vivo data was almost perfect. All the phototoxic test chemicals provided a positive result at concentrations of 1μg/ml, while nine of the ten non-phototoxic chemicals gave clear negative results, even at the highest test concentrations. One of the UV filter chemicals gave positive results in three of the four laboratories only at concentrations greater than 100μg/ml; the other laboratory correctly identified all 20 of the test chemicals. An analysis of the impact that exposure concentrations had on the performance of the test revealed that the optimum concentration range in the 3T3 NRU PT test for determining the phototoxic potential of chemicals is between 0.1μg/ml and 10μg/ml, and that false positive results can be obtained at concentrations greater than 100μg/ml. Therefore, the positive results obtained with some of the UV filter chemicals only at concentrations greater than 100μg/ml do not indicate a phototoxic potential in vivo. When this information was taken into account during calculation of the overall predictivity of the 3T3 NRU PT test in the present study, an almost perfect correlation of in vitro versus in vivo results was obtained (between 95% and 100%), when either PIF or MPE were used to predict the phototoxic potential. The management team and participants therefore conclude that the 3T3 NRU PT test is a valid test for correctly assessing the phototoxic potential of UV filter chemicals, if the defined concentration limits are taken into account.


2022 ◽  
Vol 12 ◽  
Author(s):  
Abdulkarim Najjar ◽  
Andreas Schepky ◽  
Christopher-Tilman Krueger ◽  
Matthew Dent ◽  
Sophie Cable ◽  
...  

Ethical and legal considerations have led to increased use of non-animal methods to evaluate the safety of chemicals for human use. We describe the development and qualification of a physiologically-based kinetics (PBK) model for the cosmetic UV filter ingredient, homosalate, to support its safety without the need of generating further animal data. The intravenous (IV) rat PBK model, using PK-Sim®, was developed and validated using legacy in vivo data generated prior to the 2013 EU animal-testing ban. Input data included literature or predicted physicochemical and pharmacokinetic properties. The refined IV rat PBK model was subject to sensitivity analysis to identify homosalate-specific sensitive parameters impacting the prediction of Cmax (more sensitive than AUC(0-∞)). These were then considered, together with population modeling, to calculate the confidence interval (CI) 95% Cmax and AUC(0-∞). Final model parameters were established by visual inspection of the simulations and biological plausibility. The IV rat model was extrapolated to oral administration, and used to estimate internal exposures to doses tested in an oral repeated dose toxicity study. Next, a human PBK dermal model was developed using measured human in vitro ADME data and a module to represent the dermal route. Model performance was confirmed by comparing predicted and measured values from a US-FDA clinical trial (Identifier: NCT03582215, https://clinicaltrials.gov/). Final exposure estimations were obtained in a virtual population and considering the in vitro and input parameter uncertainty. This model was then used to estimate the Cmax and AUC(0–24 h) of homosalate according to consumer use in a sunscreen. The developed rat and human PBK models had a good biological basis and reproduced in vivo legacy rat and human clinical kinetics data. They also complied with the most recent WHO and OECD recommendations for assessing the confidence level. In conclusion, we have developed a PBK model which predicted reasonably well the internal exposure of homosalate according to different exposure scenarios with a medium to high level of confidence. In the absence of in vivo data, such human PBK models will be the heart of future completely non-animal risk assessments; therefore, valid approaches will be key in gaining their regulatory acceptance.Clinical Trial Registration: https://clinicaltrials.gov/, identifier, NCT03582215


2018 ◽  
Vol 32 (1) ◽  
pp. 22-31 ◽  
Author(s):  
Santo Scalia ◽  
Sarah Battaglioli ◽  
Anna Bianchi

2002 ◽  
Vol 91 (4) ◽  
pp. 204-208 ◽  
Author(s):  
Henrik Holbech ◽  
Ulrik Nørum ◽  
Bodil Korsgaard ◽  
Poul Bjerregaard
Keyword(s):  

2017 ◽  
Vol 24 (32) ◽  
pp. 25061-25070 ◽  
Author(s):  
Anežka Sharma ◽  
Katarína Bányiová ◽  
Branislav Vrana ◽  
Ivan Justan ◽  
Pavel Čupr

RSC Advances ◽  
2017 ◽  
Vol 7 (28) ◽  
pp. 16991-16996 ◽  
Author(s):  
Yiran Liang ◽  
Jing Zhan ◽  
Xueke Liu ◽  
Zhiqaing Zhou ◽  
Wentao Zhu ◽  
...  

.The stereoselective metabolism of the enantiomers of the UV-filter 2-ethylhexyl 4-dimethylaminobenzoate (EDP) and its two major metabolites were studied in rabbits in vivo and in vitro. Cytotoxicity of EDP and its two metabolites was also investigated in hepatocytes.


2021 ◽  
Vol 20 (2) ◽  
pp. 191-200
Author(s):  
Irein Kusuma Angreini ◽  
Aniek Prasetyaningsih ◽  
Vinsa Cantya Prakasita

UV filters are necessary since UV rays are harmful to human skin. UV filter compounds in commercial sunscreen products can cause adverse effects. Thus, natural UV filters containing flavonoids, e.g. Frangipani (Plumeria alba Linn.) leaves, are needed. This research examined the use of flavonoids from P. alba leaf as a UV filter with in vitro and in vivo. Maceration was performed with 70% ethyl alco-hol and liquid-liquid extraction for flavonoid purification. Parameters tested were total flavonoid compounds, SPF value, and clinical symptoms of the melanogenesis inhibition scoring. The purification result was 43.6%. The flavonoid concentration in pure extract (64.4 mg QE /g) was higher than crude extract (57.6 mg QE/g). The highest SPF value (33.88) was observed in pure extract at 1400 mg/mL, while the same concentration of crude extract resulted in a lower SPF value (33.06). Pearson correlation analysis (0.536) indicated a di-rectly proportional relationship between SPF value and extract concentration. In vivo analysis was performed by scoring between 0-4 following the severity of erythema. After 21 days of sunlight exposure, the worst erythema was found in the negative control group (score 1.292). The best result was found in the group treated with pure extract 1400 mg/ml (score 0.542).


Author(s):  
S. Phyllis Steamer ◽  
Rosemarie L. Devine

The importance of radiation damage to the skin and its vasculature was recognized by the early radiologists. In more recent studies, vascular effects were shown to involve the endothelium as well as the surrounding connective tissue. Microvascular changes in the mouse pinna were studied in vivo and recorded photographically over a period of 12-18 months. Radiation treatment at 110 days of age was total body exposure to either 240 rad fission neutrons or 855 rad 60Co gamma rays. After in vivo observations in control and irradiated mice, animals were sacrificed for examination of changes in vascular fine structure. Vessels were selected from regions of specific interest that had been identified on photomicrographs. Prominent ultrastructural changes can be attributed to aging as well as to radiation treatment. Of principal concern were determinations of ultrastructural changes associated with venous dilatations, segmental arterial stenosis and tortuosities of both veins and arteries, effects that had been identified on the basis of light microscopic observations. Tortuosities and irregularly dilated vein segments were related to both aging and radiation changes but arterial stenosis was observed only in irradiated animals.


Author(s):  
E. J. Kollar

The differentiation and maintenance of many specialized epithelial structures are dependent on the underlying connective tissue stroma and on an intact basal lamina. These requirements are especially stringent in the development and maintenance of the skin and oral mucosa. The keratinization patterns of thin or thick cornified layers as well as the appearance of specialized functional derivatives such as hair and teeth can be correlated with the specific source of stroma which supports these differentiated expressions.


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