| 1. |
- Belsito, D., et al.
(författare)
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A toxicologic and dermatologic assessment of cyclopentanones and cyclopentenones when used as fragrance ingredients
- 2012
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Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 50, s. 517-556
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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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| 2. |
- 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 BV. - 0278-6915. ; 50, s. 269-313
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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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| 3. |
- Belsito, D., et al.
(författare)
-
A toxicological and dermatological assessment of aryl alkyl alcohols when used as fragrance ingredients
- 2012
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 50, s. 52-99
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Forskningsöversikt (refereegranskat)abstract
- The aryl alkyl alcohol (AAA) fragrance ingredients are a diverse group of chemical structures with similar metabolic and toxicity profiles. The AAA fragrances demonstrate low acute and subchronic dermal and oral toxicity. No carcinogenicity in rats or mice was observed in 2-year chronic testing of benzyl alcohol or alpha-methylbenzyl alcohol: the latter did induce species and gender-specific renal adenomas in male rats at the high dose. There was no to little genotoxicity, mutagenicity, or clastogenicity in the mutagenic in vitro bacterial assays, and in vitro mammalian cell assays. All in vivo micronucleus assays were negative. NOAELs for maternal and developmental toxicity are far in excess of current human exposure levels. At concentrations likely to be encountered by consumers, AAA fragrance ingredients are non-irritating to the skin. The potential for eye irritation is minimal. With the exception of benzyl alcohol and to a lesser extent phenethyl and 2-phenoxyethyl AAA alcohols, human sensitization studies, diagnostic patch tests and human induction studies, indicate that AAA fragrance ingredients generally have no or low sensitization potential. Available data indicate that the potential for photosensitization is low. 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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