A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients

D. Belsito; D. Bickers; M. Bruze; P. Calow; M. L. Dagli; A. D. Fryer; H. Greim; Y. Miyachi; J. H. Saurat; I. G. Sipes

doi:10.1016/j.fct.2013.09.033

A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients

D. Belsito, D. Bickers, M. Bruze, P. Calow, M. L. Dagli, A. D. Fryer, H. Greim, Y. Miyachi, J. H. Saurat, I. G. Sipes

Research output: Contribution to journal › Review article › peer-review

13 Scopus citations

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.

Original language	English (US)
Pages (from-to)	S1-S44
Journal	Food and Chemical Toxicology
Volume	62
DOIs	https://doi.org/10.1016/j.fct.2013.09.033
State	Published - Dec 2013

Bibliographical note

Funding Information:
This research was supported by the Research Institute for Fragrance Materials, an independent research institute that is funded by the manufacturers of fragrances and consumer products containing fragrances. The authors are all members of the Expert Panel of the Research Institute for Fragrance Materials, an independent group of experts who evaluate the safety of fragrance materials. Members of the Expert Panel are paid an honorarium in recognition of their time spent at the Panel meetings.

Keywords

Alkyl cyclic ketone
Assessment
Dermatology
Group summary
Toxicology

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10.1016/j.fct.2013.09.033

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title = "A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients",

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.",

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author = "D. Belsito and D. Bickers and M. Bruze and P. Calow and Dagli, {M. L.} and Fryer, {A. D.} and H. Greim and Y. Miyachi and Saurat, {J. H.} and Sipes, {I. G.}",

note = "Funding Information: This research was supported by the Research Institute for Fragrance Materials, an independent research institute that is funded by the manufacturers of fragrances and consumer products containing fragrances. The authors are all members of the Expert Panel of the Research Institute for Fragrance Materials, an independent group of experts who evaluate the safety of fragrance materials. Members of the Expert Panel are paid an honorarium in recognition of their time spent at the Panel meetings. ",

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T1 - A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients

AU - Belsito, D.

AU - Bickers, D.

AU - Bruze, M.

AU - Calow, P.

AU - Dagli, M. L.

AU - Fryer, A. D.

AU - Greim, H.

AU - Miyachi, Y.

AU - Saurat, J. H.

AU - Sipes, I. G.

N1 - Funding Information: This research was supported by the Research Institute for Fragrance Materials, an independent research institute that is funded by the manufacturers of fragrances and consumer products containing fragrances. The authors are all members of the Expert Panel of the Research Institute for Fragrance Materials, an independent group of experts who evaluate the safety of fragrance materials. Members of the Expert Panel are paid an honorarium in recognition of their time spent at the Panel meetings.

PY - 2013/12

Y1 - 2013/12

N2 - 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.

AB - 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.

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KW - Assessment

KW - Dermatology

KW - Group summary

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ER -

A toxicological and dermatological assessment of alkyl cyclic ketones when used as fragrance ingredients

Abstract

Bibliographical note

Keywords

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