RIFM fragrance ingredient safety assessment, β-caryophyllene, CAS Registry Number 87-44-5.
Academies and Institutes
/ standards
Animals
Dermatitis, Photoallergic
Dermatitis, Phototoxic
Endpoint Determination
Environmental Exposure
/ adverse effects
Europe
Fertility
/ drug effects
Humans
Mutagenicity Tests
North America
Odorants
/ analysis
Perfume
/ chemistry
Plants, Edible
/ chemistry
Polycyclic Sesquiterpenes
/ analysis
Quantitative Structure-Activity Relationship
Registries
Reproduction
/ drug effects
Respiratory System
/ drug effects
Risk Assessment
Safety
Skin
/ drug effects
Toxicity Tests
Journal
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association
ISSN: 1873-6351
Titre abrégé: Food Chem Toxicol
Pays: England
ID NLM: 8207483
Informations de publication
Date de publication:
15 Jan 2022
15 Jan 2022
Historique:
received:
22
09
2021
revised:
28
10
2021
accepted:
24
11
2021
pubmed:
2
12
2021
medline:
22
1
2022
entrez:
1
12
2021
Statut:
ppublish
Résumé
The existing information supports the use of this material as described in this safety assessment. β-Caryophyllene was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that β-caryophyllene is not genotoxic. Data on β-caryophyllene provided a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and fertility endpoints. The developmental and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to β-caryophyllene is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively. Data show that there are no safety concerns for β-caryophyllene for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; β-caryophyllene is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; β-caryophyllene was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
Identifiants
pubmed: 34848252
pii: S0278-6915(21)00740-7
doi: 10.1016/j.fct.2021.112707
pii:
doi:
Substances chimiques
Perfume
0
Polycyclic Sesquiterpenes
0
caryophyllene
BHW853AU9H
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
112707Informations de copyright
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