RIFM low-exposure fragrance ingredients safety assessment

A. M. Api; D. Belsito; S. Biserta; D. Botelho; M. Bruze; G. A. Burton; J. Buschmann; M. A. Cancellieri; M. L. Dagli; M. Date; W. Dekant; C. Deodhar; A. D. Fryer; S. Gadhia; L. Jones; K. Joshi; A. Lapczynski; M. Lavelle; D. C. Liebler; M. Na; D. O'Brien; A. Patel; T. M. Penning; G. Ritacco; F. Rodriguez-Ropero; J. Romine; N. Sadekar; D. Salvito; T. W. Schultz; F. Siddiqi; I. G. Sipes; G. Sullivan; Y. Thakkar; Y. Tokura; S. Tsang

doi:10.1016/j.fct.2021.111981

RIFM low-exposure fragrance ingredients safety assessment

A. M. Api, D. Belsito, S. Biserta, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, S. Gadhia, L. Jones, K. Joshi, A. Lapczynski, M. Lavelle, D. C. Liebler, M. NaD. O'Brien, A. Patel, T. M. Penning, G. Ritacco, F. Rodriguez-Ropero, J. Romine, N. Sadekar, D. Salvito, T. W. Schultz, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura, S. Tsang

Research output: Contribution to journal › Article › peer-review

Abstract

The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm² and 64 μg/cm², respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

Original language	English
Article number	111981
Journal	Food and Chemical Toxicology
Volume	149
Early online date	2021 Feb 10
DOIs	https://doi.org/10.1016/j.fct.2021.111981
Publication status	Published - 2021
Externally published	Yes

Subject classification (UKÄ)

Pharmacology and Toxicology

Free keywords

Environmental safety
Genotoxicity
Local respiratory toxicity
Low exposure fragrance materials
Phototoxicity/photoallergenicity
Repeated dose, developmental, and reproductive toxicity
Skin sensitization

Access to Document

10.1016/j.fct.2021.111981

Cite this

Api, A. M., Belsito, D., Biserta, S., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Cancellieri, M. A., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Fryer, A. D., Gadhia, S., Jones, L., Joshi, K., Lapczynski, A., Lavelle, M., Liebler, D. C., ... Tsang, S. (2021). RIFM low-exposure fragrance ingredients safety assessment. Food and Chemical Toxicology, 149, Article 111981. https://doi.org/10.1016/j.fct.2021.111981

@article{dea06dbf45104b5e9bb7e1b8a92dc521,

title = "RIFM low-exposure fragrance ingredients safety assessment",

abstract = "The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm2 and 64 μg/cm2, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.",

keywords = "Environmental safety, Genotoxicity, Local respiratory toxicity, Low exposure fragrance materials, Phototoxicity/photoallergenicity, Repeated dose, developmental, and reproductive toxicity, Skin sensitization",

author = "Api, {A. M.} and D. Belsito and S. Biserta and D. Botelho and M. Bruze and Burton, {G. A.} and J. Buschmann and Cancellieri, {M. A.} and Dagli, {M. L.} and M. Date and W. Dekant and C. Deodhar and Fryer, {A. D.} and S. Gadhia and L. Jones and K. Joshi and A. Lapczynski and M. Lavelle and Liebler, {D. C.} and M. Na and D. O'Brien and A. Patel and Penning, {T. M.} and G. Ritacco and F. Rodriguez-Ropero and J. Romine and N. Sadekar and D. Salvito and Schultz, {T. W.} and F. Siddiqi and Sipes, {I. G.} and G. Sullivan and Y. Thakkar and Y. Tokura and S. Tsang",

year = "2021",

doi = "10.1016/j.fct.2021.111981",

language = "English",

volume = "149",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier",

}

Api, AM, Belsito, D, Biserta, S, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Cancellieri, MA, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Fryer, AD, Gadhia, S, Jones, L, Joshi, K, Lapczynski, A, Lavelle, M, Liebler, DC, Na, M, O'Brien, D, Patel, A, Penning, TM, Ritacco, G, Rodriguez-Ropero, F, Romine, J, Sadekar, N, Salvito, D, Schultz, TW, Siddiqi, F, Sipes, IG, Sullivan, G, Thakkar, Y, Tokura, Y & Tsang, S 2021, 'RIFM low-exposure fragrance ingredients safety assessment', Food and Chemical Toxicology, vol. 149, 111981. https://doi.org/10.1016/j.fct.2021.111981

TY - JOUR

T1 - RIFM low-exposure fragrance ingredients safety assessment

AU - Api, A. M.

AU - Belsito, D.

AU - Biserta, S.

AU - Botelho, D.

AU - Bruze, M.

AU - Burton, G. A.

AU - Buschmann, J.

AU - Cancellieri, M. A.

AU - Dagli, M. L.

AU - Date, M.

AU - Dekant, W.

AU - Deodhar, C.

AU - Fryer, A. D.

AU - Gadhia, S.

AU - Jones, L.

AU - Joshi, K.

AU - Lapczynski, A.

AU - Lavelle, M.

AU - Liebler, D. C.

AU - Na, M.

AU - O'Brien, D.

AU - Patel, A.

AU - Penning, T. M.

AU - Ritacco, G.

AU - Rodriguez-Ropero, F.

AU - Romine, J.

AU - Sadekar, N.

AU - Salvito, D.

AU - Schultz, T. W.

AU - Siddiqi, F.

AU - Sipes, I. G.

AU - Sullivan, G.

AU - Thakkar, Y.

AU - Tokura, Y.

AU - Tsang, S.

PY - 2021

Y1 - 2021

N2 - The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm2 and 64 μg/cm2, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

AB - The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm2 and 64 μg/cm2, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

KW - Environmental safety

KW - Genotoxicity

KW - Local respiratory toxicity

KW - Low exposure fragrance materials

KW - Phototoxicity/photoallergenicity

KW - Repeated dose, developmental, and reproductive toxicity

KW - Skin sensitization

U2 - 10.1016/j.fct.2021.111981

DO - 10.1016/j.fct.2021.111981

M3 - Article

C2 - 33577945

AN - SCOPUS:85100966006

SN - 0278-6915

VL - 149

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 111981

ER -

RIFM low-exposure fragrance ingredients safety assessment

Abstract

Subject classification (UKÄ)

Free keywords

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