| 1. |
- von Kobyletzki, Laura B., 1971-, et al.
(författare)
-
Prevalence of dermatitis including allergic contact dermatitis from medical devices used by children and adults with Type 1 diabetes mellitus : A systematic review and questionnaire study
- 2024
-
Ingår i: Journal of the European Academy of Dermatology and Venereology. - : Blackwell Publishing. - 0926-9959 .- 1468-3083. ; 38:7, s. 1329-1346
-
Forskningsöversikt (refereegranskat)abstract
- Use of medical devices (MDs), that is, glucose sensors and insulin pumps, in patients with Type 1 diabetes mellitus (T1D) has proven an enormous advantage for disease control. Adverse skin reactions from these MDs may however hamper compliance. The objective of this study was to systematically review and analyse studies assessing the prevalence and incidence of dermatitis, including allergic contact dermatitis (ACD) related to MDs used in patients with T1D and to compare referral routes and the clinical investigation routines between clinics being part of the European Environmental and Contact Dermatitis Research Group (EECDRG). A systematic search of PubMed, EMBASE, CINAHL and Cochrane databases of full-text studies reporting incidence and prevalence of dermatitis in persons with T1D using MDs was conducted until December 2021. The Newcastle-Ottawa Scale was used to assess study quality. The inventory performed at EECRDG clinics focused on referral routes, patient numbers and the diagnostic process. Among the 3145 screened abstracts, 39 studies fulfilled the inclusion criteria. Sixteen studies included data on children only, 14 studies were on adults and nine studies reported data on both children and adults. Participants were exposed to a broad range of devices. Skin reactions were rarely specified. It was found that both the diagnostic process and referral routes differ in different centres. Further data on the prevalence of skin reactions related to MDs in individuals with T1D is needed and particularly studies where the skin reactions are correctly diagnosed. A correct diagnosis is delayed or hampered by the fact that, at present, the actual substances within the MDs are not declared, are changed without notice and the commercially available test materials are not adequately updated. Within Europe, routines for referral should be made more standardized to improve the diagnostic procedure when investigating patients with possible ACD from MDs.
|
|
| 2. |
- Belsito, D., et al.
(författare)
-
A safety assessment of branched chain saturated alcohols when used as fragrance ingredients
- 2010
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 48, s. 1-46
-
Forskningsöversikt (refereegranskat)abstract
- The Branched Chain Saturated Alcohol (BCSA) group of fragrance ingredients was evaluated for safety. In humans, no evidence of skin irritation was found at concentrations of 2-10%. Undiluted, 11 materials evaluated caused moderate to severe eye irritation. As current end product use levels are between 0.001% and 1.7%, eye irritation is not a concern. The materials have no or low sensitizing potential. For individuals who are already sensitized, an elicitation reaction is possible. Due to lack of UVA/UVB light-absorbing structures, and review of phototoxic/photoallergy data, the BCSA are not expected to elicit phototoxicity or photoallergy. The 15 materials tested have a low order of acute toxicity. Following repeated application, seven BCSA tested were of low systemic toxicity. Studies performed on eight BCSA and three metabolites show no in vivo or in vitro genotoxicity. A valid carcinogenicity study showed that 2-ethyl-1-hexanol is a weak inducer of liver tumors in female mice, however, the relevance of this effect and mode of action to humans is still a matter of debate. The Panel is of the opinion that there are no safety concerns regarding BCSA under the present levels of use and exposure. (C) 2010 Elsevier Ltd. All rights reserved.
|
|
| 3. |
- Belsito, D., et al.
(författare)
-
A toxicologic and dermatologic assessment of cinnamyl phenylpropyl materials when used as fragrance ingredients
- 2011
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 49:Suppl. 2, s. 256-267
-
Forskningsöversikt (refereegranskat)abstract
- The cinnamyl phenylpropyl fragrance ingredients are a diverse group of chemical structures that have similar metabolic and toxicity profiles. A toxicological and dermatological review of these fragrance ingredients is presented. The common characteristic structural element of cinnamyl phenylpropyl materials is an aryl substituted primary alcohol/aldehyde/ester. For high end users, calculated maximum dermal exposures vary from 0.14% to 0.72%; systemic exposures vary from 0.0002 to 0.0280 mg/kg/day. Human dermatological studies show that these materials are not generally irritants or sensitizers at lower exposures from consumer products. Reactions (0.9%) in fragrance sensitive patients were observed with 3-phenyl-1-propanol at 5% in petrolatum. The cinnamyl phenylpropyl materials had low acute toxicity and no significant toxicity in repeat dose oral or dermal toxicity studies. No mutagenic or genotoxic activity in bacteria and mammalian cell line assays was observed. The cinnamyl phenylpropyl alcohol materials participate in the same beta oxidation pathways as their parent cinnamic acid derivatives, including common routes of absorption, distribution, and metabolic detoxification, and exhibit similar toxicological endpoints. Based on the review of available data, it is concluded that these materials would not present a safety concern at current levels of use as fragrance ingredients. (C) 2011 Elsevier Ltd. All rights reserved.
|
|
| 4. |
|
|
| 5. |
|
|
| 6. |
- Belsito, D., et al.
(författare)
-
A toxicologic and dermatologic assessment of cyclopentanones and cyclopentenones when used as fragrance ingredients
- 2012
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 50, s. 517-556
-
Forskningsöversikt (refereegranskat)abstract
- The cyclopentanone and cyclopentenone group of fragrance ingredients was critically evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.002% to 15.16% in hydroalcoholic products; systemic exposures vary from 0.0003 to 0.7122 mg/kg/day. The cyclopentanones and cyclopentenones had a low order of acute toxicity and no significant toxicity in repeat dose studies. No mutagenic or genotoxic activity in bacteria and mammalian cell line assays was observed. Developmental toxicity was not observed. Minimal evidence of skin irritation in humans is associated with current levels of use. Eleven materials were tested undiluted for eye irritation; three were considered irritants. No phototoxic and photosensitization reactions were seen with nine materials tested. At concentrations higher than current reported use, 14 materials were non-sensitizing in HRIPT or maximization tests. 2-Hexylidene cyclopentanone, 2-heptylidenecyclopentan-1-one and 3-methyl-2-(pentyloxy)-2-cyclopenten-1-one are weak sensitizers and have IFRA Standards. Risk of sensitization to the cyclopentanones and cyclopentenones is generally small under current levels of use. The Panel is of the opinion that there are no safety concerns for the cyclopentanones and cyclopentenones at reported levels of use and exposure as fragrance ingredients. (C) 2012 Elsevier Ltd. All rights reserved.
|
|
| 7. |
|
|
| 8. |
|
|
| 9. |
|
|
| 10. |
- Belsito, D., et al.
(författare)
-
A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients The RIFM Expert Panel
- 2013
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 62, s. 1-44
-
Forskningsöversikt (refereegranskat)abstract
- The alkyl cyclic ketone (ACK) fragrance ingredients are a diverse group of structures with Similar metabolic and toxicity profiles. ACK fragrance materials demonstrate low acute toxicity. Upon repeat dose testing, some adverse effects in biochemical and hematological parameters, and slightly increased liver and kidney weights were reported, primarily at high doses, resulting from adaptive effects. Developmental effects occurred only in the presence of maternal toxicity. Assays in bacteria and mammalian cell systems and the mouse micronucleus assay did not demonstrate genotoxicity. ACK fragrance ingredients are considered non-irritating to the skin of humans; results showed few reactions, most of which were equivocal or involved doses greater than those in consumer products. Mild to moderate eye irritation in animal tests was observed with most compounds; however, full recovery was usually observed. Human sensitization studies indicate that ACK fragrance ingredients have a low sensitization potential. Diagnostic patch-tests indicated low sensitizing potential in humans; except for fragrance materials which caused reactions at 1% or 5%. Phototoxicity and photosensitization were not demonstrated in humans, and, with the possible exception of acetyl cedrene, would not be expected. It is concluded that ACK materials do not present a safety concern at current levels of use as fragrance ingredients. (C) 2013 Elsevier Ltd. All rights reserved.
|
|
