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A toxicological and dermatological assessment of macrocyclic ketones when used as fragrance ingredients* The RIFM Expert Panel

Belsito, D.; Bickers, D.; Bruze, Magnus LU ; Calow, P.; Dagli, M. L.; Fryer, A. D.; Greim, H.; Miyachi, Y.; Saurat, J. H. and Sipes, I. G. (2011) In Food and Chemical Toxicology 49(Suppl. 2). p.126-141
Abstract
The macrocyclic ketone (MK) group of fragrance ingredients was evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.13% to 1.10%; systemic exposures vary from 0.0005 to 0.0441 mg/kg/day. The MKs had low acute toxicity and no significant repeat dose toxicity. Liver weight and blood biochemistry effects were reversible after 2 weeks. No genotoxicity in bacteria and mammalian cell lines was observed. Reproductive toxicity was not observed for 3-methylcyclopentadecenone in an OECD compliant study. In humans, MKs are generally not irritating after one application. Animal studies showed irritation for some materials at concentrations higher than current consumer... (More)
The macrocyclic ketone (MK) group of fragrance ingredients was evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.13% to 1.10%; systemic exposures vary from 0.0005 to 0.0441 mg/kg/day. The MKs had low acute toxicity and no significant repeat dose toxicity. Liver weight and blood biochemistry effects were reversible after 2 weeks. No genotoxicity in bacteria and mammalian cell lines was observed. Reproductive toxicity was not observed for 3-methylcyclopentadecenone in an OECD compliant study. In humans, MKs are generally not irritating after one application. Animal studies showed irritation for some materials at concentrations higher than current consumer exposure. At rates consistent with current human exposure, phototoxicity and photosensitization were not observed. In animals, some MKs are sensitizers only at concentrations of 20%, 30%, or 100%, which are higher than current consumer exposure. No evidence of sensitization was observed in human tests. In patients with fragrance allergy, reactions were seen with cyclopentadecanone (3/178). Based on these findings, the Panel is of the opinion that there are no safety concerns for the MKs at reported levels of use and exposure as fragrance ingredients. (C) 2011 Published by Elsevier Ltd. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Safety, Review, Fragrance, Macrocyclic ketone
in
Food and Chemical Toxicology
volume
49
issue
Suppl. 2
pages
126 - 141
publisher
Elsevier
external identifiers
  • wos:000299404000009
  • scopus:84155167178
ISSN
0278-6915
DOI
10.1016/j.fct.2011.07.040
language
English
LU publication?
yes
id
5ad492f9-9b9a-456f-9544-75edada7b25d (old id 2344968)
date added to LUP
2012-02-24 13:58:27
date last changed
2017-10-29 03:56:19
@article{5ad492f9-9b9a-456f-9544-75edada7b25d,
  abstract     = {The macrocyclic ketone (MK) group of fragrance ingredients was evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.13% to 1.10%; systemic exposures vary from 0.0005 to 0.0441 mg/kg/day. The MKs had low acute toxicity and no significant repeat dose toxicity. Liver weight and blood biochemistry effects were reversible after 2 weeks. No genotoxicity in bacteria and mammalian cell lines was observed. Reproductive toxicity was not observed for 3-methylcyclopentadecenone in an OECD compliant study. In humans, MKs are generally not irritating after one application. Animal studies showed irritation for some materials at concentrations higher than current consumer exposure. At rates consistent with current human exposure, phototoxicity and photosensitization were not observed. In animals, some MKs are sensitizers only at concentrations of 20%, 30%, or 100%, which are higher than current consumer exposure. No evidence of sensitization was observed in human tests. In patients with fragrance allergy, reactions were seen with cyclopentadecanone (3/178). Based on these findings, the Panel is of the opinion that there are no safety concerns for the MKs at reported levels of use and exposure as fragrance ingredients. (C) 2011 Published by Elsevier Ltd.},
  author       = {Belsito, D. and Bickers, D. and Bruze, Magnus and Calow, P. and Dagli, M. L. and Fryer, A. D. and Greim, H. and Miyachi, Y. and Saurat, J. H. and Sipes, I. G.},
  issn         = {0278-6915},
  keyword      = {Safety,Review,Fragrance,Macrocyclic ketone},
  language     = {eng},
  number       = {Suppl. 2},
  pages        = {126--141},
  publisher    = {Elsevier},
  series       = {Food and Chemical Toxicology},
  title        = {A toxicological and dermatological assessment of macrocyclic ketones when used as fragrance ingredients* The RIFM Expert Panel},
  url          = {http://dx.doi.org/10.1016/j.fct.2011.07.040},
  volume       = {49},
  year         = {2011},
}