| 11. |
- Belsito, D., et al.
(författare)
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A toxicological and dermatological assessment of aryl alkyl alcohols when used as fragrance ingredients
- 2012
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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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| 12. |
- Belsito, D., et al.
(författare)
-
A toxicological and dermatological assessment of macrocyclic lactone and lactide derivatives when used as fragrance ingredients
- 2011
-
Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915. ; 49:Suppl. 2, s. 219-241
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Forskningsöversikt (refereegranskat)abstract
- The Macrocyclic Lactone and Lactide derivative (ML) group of fragrance ingredients was critically evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.47% to 11.15%; systemic exposures vary from 0.0008 to 0.25 mg/kg/day. The MLs had low acute toxicity and no significant toxicity in repeat dose oral ordermal toxicity studies. Effects on blood biochemistry were reversible after 2 weeks of no treatment. No mutagenic or genotoxic activity in bacteria and mammalian cell line assays was observed. Reproductive and developmental toxicity was not observed. Human dermatological studies show MLs are generally not irritating after one application. Minor irritation was observed in a few individuals following multiple applications. At rates consistent with reported levels for current human exposure, no phototoxicity or photosensitization was observed. In animal studies, the MLs are not sensitizers at lower exposures from consumer products. Eleven ML materials were evaluated for human sensitization. Of these, only ethylene brassylate showed evidence of sensitization in 2/27 studies (sensitization frequency 4/2059 total). Based on these findings, the Panel is of the opinion that there are no safety concerns for the MLs at reported levels of use and exposure as fragrance ingredients. (C) 2011 Published by Elsevier Ltd.
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