A Short-Term Inhalation Study Protocol: Designed for Testing of Toxicity and Fate of Nanomaterials

2014 ◽  
pp. 207-212 ◽  
Author(s):  
Lan Ma-Hock ◽  
Thomas Hofmann ◽  
Robert Landsiedel ◽  
Bennard van Ravenzwaay
Keyword(s):  
Study Protocol ◽  
Short Term ◽  
Inhalation Study

scholarly journals Breastfeeding Mother and Child Clinical Outcomes After COVID-19 Vaccination

2021 ◽  
pp. 089033442110565
Author(s):  
Jia Ming Low ◽  
Le Ye Lee ◽  
Yvonne Peng Mei Ng ◽  
Youjia Zhong ◽  
Zubair Amin
Keyword(s):  
Adverse Effects ◽  
Study Protocol ◽  
Messenger Rna ◽  
Hospital Admissions ◽  
Vaccine Dose ◽  
Common Side Effect ◽  
Short Term ◽  
Serious Adverse Events ◽  
Axillary Lymphadenopathy ◽  
Breastfed Infants

Background: Pre-approval clinical trials of the Pfizer/BioNTech messenger RNA COVID-19 vaccine, BNT162b2 did not include participants who were breastfeeding. Therefore, there is limited evidence about outcomes of breastfeeding mother–child dyads and effects on breastfeeding after vaccination. Research Aims: To determine: (1) solicited adverse effects (e.g., axillary lymphadenopathy, mastitis, and breast engorgement), which are unique to lactating individuals; and (2) systemic and local adverse effects of COVID-19 mRNA vaccine on mothers and potential effects on their breastfed infants. Method: This was a prospective cohort study of lactating healthcare workers ( N = 88) in Singapore who received two doses of BNT162b2 vaccination (Pfizer/BioNTech). The outcomes of mother–child dyads within 28 days after the second vaccine dose were determined through a participant-completed questionnaire. Results: Minimal effects related to breastfeeding were reported by this cohort; three of 88 (3.4%) participants had mastitis, one (1.1%) participant experienced breast engorgement, five of 88 (5.7%) participants reported cervical or axillary lymphadenopathy. There was no change in human milk supply after vaccination. The most common side effect was pain/redness/swelling at the injection site, which was experienced by 57 (64.8%) participants. There were no serious adverse events of anaphylaxis or hospital admissions. There were no short-term adverse effects reported in the infants of 67 lactating participants who breastfed within 72 hr after BNT162b2 vaccination. Conclusions: BNT162b2 vaccination was well tolerated in lactating participants and was not associated with short-term adverse effects in their breastfed infants. Study Protocol Registration: The study protocol was registered at clinicaltrials.gov (NCT04802278).

scholarly journals Final Report on the Safety Assessment of Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24–28 Alkyl Methicone, C30–45 Alkyl Methicone, C30–45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone

2003 ◽  
Vol 22 (2_suppl) ◽  
pp. 10-35
Keyword(s):  
Adverse Effects ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Oral Exposure ◽  
Final Report ◽  
Short Term ◽  
Fluid Mixture ◽  
Inhalation Study ◽  
Cosmetic Formulations ◽  
Siloxane Polymers

Dimethicone is a fluid mixture of fully methylated linear siloxane polymers end-blocked with trimethylsiloxy units. Methicone is a linear monomethyl polysiloxane. The other dimethicones and methicones covered in this review are siloxane polymers of Dimethicone and Methicone. Most of these ingredients function as conditioning agents in cosmetic formulations at current concentrations of use of ≤ 15%. Clinical and animal absorption studies reported that Dimethicone was not absorbed following oral or dermal exposure. Dimethicone, Methicone, and Vinyldimethicone were not acutely toxic following oral exposure. No adverse reactions were found in rabbits following short-term dermal dosing with 6% to 79% Dimethicone, yet adverse effects were noted with a hand cream formulation containing 1% Dimethicone, suggesting something else in the preparation was toxic. Mice and rats were dosed for 90 days with up to 10% Dimethicone without adverse effect. Dimethicone did not produce adverse effects in acute and short-term inhalation-route studies, Methicone and Vinyldimethicone were negative in acute exposure studies using rats, but Hexyl Methicone was toxic to rats at 5 mg/L delivered in small particle (mean diameter of 0.29 μ) aerosols. Most dermal irritation studies using rabbits classified Dimethicone as a minimal irritant. Dimethicone (tested undiluted and at 79%) was not a sensitizer in four assays using mice and guinea pigs. It was not a sensitizer at 5.0% in a clinical repeated insult patch test using 83 panelists. Most ocular irritation studies using rabbits classified Dimethicone as a mild to minimal irritant. Dimethicone was tested in numerous oral-dose (using rats) and dermal-dose (using rats, rabbits, and monkeys) reproductive and developmental toxicity studies. In a few studies, treated males had significantly decreased body weight and/or decreased testes or seminal vesicles weights. No treatment-related adverse findings were noted in dosed pregnant females or fetuses. Dimethicone was negative in all genotoxicity assays. It was negative in both an oral (tested at 91%) and dermal (tested at an unknown concentration) dose carcinogenicity assay using mice. The Cosmetic Ingredient Review (CIR) Expert Panel considered it unlikely that any of these polymers would be significantly absorbed into the skin due to their large molecular weight. Although adverse effects were noted in one inhalation study with small aerosol particles, the expected particle sizes for cosmetic products would primarily be in the range of 60 to 80 μ, and less than 1% would be under 10 μ, which is an upper limit for respirable particles. Overall, the safety test data support the safety of these ingredients at the concentrations they are known to be used in cosmetic formulations. Accordingly, the CIR Expert Panel was of the opinion that Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bis-propyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24–28 Alkyl Methicone, C30–45 Alkyl Methicone, C30–45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone are safe as used in cosmetic formulations.

scholarly journals Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Mark A Barone ◽  
Vera Frajzyngier ◽  
Steven Arrowsmith ◽  
Joseph Ruminjo ◽  
Armando Seuc ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Fistula Repair ◽  
Short Term ◽  
Urethral Catheterization ◽  
Randomized Controlled

scholarly journals A short-term inhalation study to assess the reversibility of sensory irritation in human volunteers

2020 ◽  
Vol 94 (5) ◽  
pp. 1687-1701 ◽  
Author(s):  
Stefan Kleinbeck ◽  
Michael Schäper ◽  
Marlene Pacharra ◽  
Marie Louise Lehmann ◽  
Klaus Golka ◽  
...  
Keyword(s):  
Sensory Irritation ◽  
Short Term ◽  
Inhalation Study ◽  
Human Volunteers
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