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Sökning: LAR1:lu > Refereegranskat > Forskningsöversikt > Bickers D.

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1.
  • 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 Science Ltd. - 0278-6915. ; 48, s. S1-S46
  • 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.
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  • 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 Science Ltd. - 0278-6915. ; 49:Suppl. 2, s. S256-S267
  • 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.
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  • 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. - 0278-6915. ; 50, s. S517-S556
  • 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.
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  • 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. - Pergamon-Elsevier Science Ltd.. - 0278-6915. ; 62, s. S1-S44
  • 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.
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10.
  • Belsito, D., et al. (författare)
  • A toxicological and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance ingredients
  • 2012
  • Ingår i: Food and Chemical Toxicology. - Elsevier. - 0278-6915. ; 50, s. S269-S313
  • Forskningsöversikt (refereegranskat)abstract
    • The aryl alkyl alcohol simple acid ester derivatives (AAASAE) group of fragrance ingredients was critically evaluated for safety following a complete literature search of the pertinent data. For high end users, calculated maximum skin exposures vary widely from 0.01% to 4.17%. AAASAE exhibit a common route of primary metabolism by carboxylesterases resulting in the formation of the simple acid and an aryl alkyl alcohol. They have low acute toxicity. No significant toxicity was observed in repeat-dose toxicity tests. There was no evidence of carcinogenicity of benzyl alcohol when it was administered in the feed; gavage studies resulted in pancreatic carcinogenesis due to the corn oil vehicle. The AAASAE are not mutagenic in bacterial systems or in vitro in mammalian cells, and have little to no in vivo genotoxicity. Reproductive and developmental toxicity data show no indication of adverse effects on reproductive function and NOELs for maternal and developmental toxicity are far in excess of current exposure levels. The AAASAE are generally not irritating or sensitizing at the current levels of exposure. The Panel is of the opinion that there are no safety concerns regarding the AAASAE at the current levels of use and exposure. (C) 2012 Elsevier Ltd. All rights reserved.
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