A toxicological and dermatological assessment of aryl alkyl alcohols when used as fragrance ingredients

► Repeat-dose subchronic testing did not demonstrate adverse effects. ► No carcinogenicity was observed in a 2-year study on two materials ► There was no to little genotoxicity, mutagenicity, or clastogenicity observed ► NOAELs for maternal and developmental toxicity are excess of human exposure lev...

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Published inFood and chemical toxicology Vol. 50; pp. S52 - S99
Main Authors Belsito, D., Bickers, D., Bruze, M., Calow, P., Dagli, M.L., Fryer, A.D., Greim, H., Miyachi, Y., Saurat, J.H., Sipes, I.G.
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.09.2012
Subjects
Alcohols - pharmacokinetics
Alcohols - toxicity
Animals
Aryl alkyl alcohols
Basic Medicine
benzyl alcohol
carcinogenicity
chemical structure
developmental toxicity
eye irritation
Farmakologi och toxikologi
Fragrance ingredients
genotoxicity
Guinea Pigs
Humans
ingredients
Medical and Health Sciences
Medicin och hälsovetenskap
Medicinska och farmaceutiska grundvetenskaper
mice
mutagenicity
odors
Perfume
Pharmacology and Toxicology
photosensitivity
Rats
Safety review
Skin - drug effects
Toxicity Tests
toxicology
Safety review
Aryl alkyl alcohols
Fragrance ingredients
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Abstract ► Repeat-dose subchronic testing did not demonstrate adverse effects. ► No carcinogenicity was observed in a 2-year study on two materials ► There was no to little genotoxicity, mutagenicity, or clastogenicity observed ► NOAELs for maternal and developmental toxicity are excess of human exposure levels ► Aryl alkyl alcohol fragrance materials have no or low sensitization potential. 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 α-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.
AbstractList 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 α-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.
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.
► Repeat-dose subchronic testing did not demonstrate adverse effects. ► No carcinogenicity was observed in a 2-year study on two materials ► There was no to little genotoxicity, mutagenicity, or clastogenicity observed ► NOAELs for maternal and developmental toxicity are excess of human exposure levels ► Aryl alkyl alcohol fragrance materials have no or low sensitization potential. 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 α-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.
Author Bruze, M.
Bickers, D.
Saurat, J.H.
Miyachi, Y.
Dagli, M.L.
Sipes, I.G.
Fryer, A.D.
Belsito, D.
Calow, P.
Greim, H.
AuthorAffiliation Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Avenue, New York, NY 10032, USA
AuthorAffiliation_xml – name: Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Avenue, New York, NY 10032, USA
Author_xml – sequence: 1
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  organization: Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Avenue, New York, NY 10032, USA
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  surname: Bruze
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  organization: Malmo University Hospital, Department of Occupational and Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo SE-20502, Sweden
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  organization: Science and Public Policy, Office of Research and Economic Development, 230 Whittier Research Center, Lincoln, NE 68583-0857, USA
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  surname: Dagli
  fullname: Dagli, M.L.
  organization: University of Sao Paulo, School of Veterinary Medicine and Animal Science, Department of Pathology, Av. Prof. Dr. Orlando Marques de Paiva 87, Sao Paulo CEP 05508-900, Brazil
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  fullname: Fryer, A.D.
  organization: Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA
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  surname: Greim
  fullname: Greim, H.
  organization: Technical University of Munich, Institute for Toxicology and Environmental Hygiene, Hohenbachernstrasse 15-17, Freising-Weihenstephan D-85354, Germany
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  surname: Miyachi
  fullname: Miyachi, Y.
  organization: Department of Dermatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
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  surname: Saurat
  fullname: Saurat, J.H.
  organization: Swiss Centre for Human Applied Toxicology, University Medical Center, University of Geneva, Rue Michel Servat, 1211 Geneve 4 CH, Switzerland
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  organization: Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ 85724-5050, USA
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Keywords Safety review
Aryl alkyl alcohols
Fragrance ingredients
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PublicationTitle Food and chemical toxicology
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Snippet ► Repeat-dose subchronic testing did not demonstrate adverse effects. ► No carcinogenicity was observed in a 2-year study on two materials ► There was no to...
The aryl alkyl alcohol (AAA) fragrance ingredients are a diverse group of chemical structures with similar metabolic and toxicity profiles. The AAA fragrances...
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SubjectTerms Alcohols - pharmacokinetics
Alcohols - toxicity
Animals
Aryl alkyl alcohols
Basic Medicine
benzyl alcohol
carcinogenicity
chemical structure
developmental toxicity
eye irritation
Farmakologi och toxikologi
Fragrance ingredients
genotoxicity
Guinea Pigs
Humans
ingredients
Medical and Health Sciences
Medicin och hälsovetenskap
Medicinska och farmaceutiska grundvetenskaper
mice
mutagenicity
odors
Perfume
Pharmacology and Toxicology
photosensitivity
Rats
Safety review
Skin - drug effects
Toxicity Tests
toxicology
Title A toxicological and dermatological assessment of aryl alkyl alcohols when used as fragrance ingredients
URI https://dx.doi.org/10.1016/j.fct.2011.10.042
https://www.ncbi.nlm.nih.gov/pubmed/22051184
https://search.proquest.com/docview/1126624614
https://lup.lub.lu.se/record/3287808
Volume 50
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