RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7

A. M. Api; D. Belsito; D. Botelho; M. Bruze; G. A. Burton; J. Buschmann; M. A. Cancellieri; M. L. Dagli; M. Date; W. Dekant; C. Deodhar; A. D. Fryer; L. Jones; K. Joshi; M. Kumar; A. Lapczynski; M. Lavelle; I. Lee; D. C. Liebler; H. Moustakas; M. Na; T. M. Penning; G. Ritacco; J. Romine; N. Sadekar; T. W. Schultz; D. Selechnik; F. Siddiqi; I. G. Sipes; G. Sullivan; Y. Thakkar; Y. Tokura

doi:10.1016/j.fct.2021.112181

RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I. Lee, D. C. Liebler, H. MoustakasM. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura

Forskningsoutput: Tidskriftsbidrag › Artikel i vetenskaplig tidskrift › Peer review

Sammanfattning

The existing information supports the use of this material as described in this safety assessment. Hexadeca-1,5-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog hydroxynonanoic acid, δ-lactone (CAS # 3301-94-8) show that hexadeca-1,5-lactone is not expected to be genotoxic. Data from analog δ-decalactone (CAS # 705-86-2) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog δ-octalactone (CAS # 698-76-0) show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexadeca-1,5-lactone is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). For the hazard assessment based on the screening data, hexadeca-1,5-lactone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Hexadeca-1,5-lactone could not be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.

Originalspråk	engelska
Artikelnummer	112181
Tidskrift	Food and Chemical Toxicology
Volym	153
Tidigt onlinedatum	2021
DOI	https://doi.org/10.1016/j.fct.2021.112181
Status	Published - 2021
Externt publicerad	Ja

Ämnesklassifikation (UKÄ)

Farmakologi och toxikologi

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10.1016/j.fct.2021.112181

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Api, A. M., Belsito, D., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Cancellieri, M. A., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Fryer, A. D., Jones, L., Joshi, K., Kumar, M., Lapczynski, A., Lavelle, M., Lee, I., Liebler, D. C., ... Tokura, Y. (2021). RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7. Food and Chemical Toxicology, 153, Artikel 112181. https://doi.org/10.1016/j.fct.2021.112181

@article{f7b50448aaee42b6a5226e2034aaa8c5,

title = "RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7",

abstract = "The existing information supports the use of this material as described in this safety assessment. Hexadeca-1,5-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog hydroxynonanoic acid, δ-lactone (CAS # 3301-94-8) show that hexadeca-1,5-lactone is not expected to be genotoxic. Data from analog δ-decalactone (CAS # 705-86-2) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog δ-octalactone (CAS # 698-76-0) show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexadeca-1,5-lactone is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). For the hazard assessment based on the screening data, hexadeca-1,5-lactone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Hexadeca-1,5-lactone could not be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.",

keywords = "And reproductive toxicity, Developmental, Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, Skin sensitization",

author = "Api, {A. M.} and D. Belsito 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 L. Jones and K. Joshi and M. Kumar and A. Lapczynski and M. Lavelle and I. Lee and Liebler, {D. C.} and H. Moustakas and M. Na and Penning, {T. M.} and G. Ritacco and J. Romine and N. Sadekar and Schultz, {T. W.} and D. Selechnik and F. Siddiqi and Sipes, {I. G.} and G. Sullivan and Y. Thakkar and Y. Tokura",

year = "2021",

doi = "10.1016/j.fct.2021.112181",

language = "English",

volume = "153",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier",

}

Api, AM, Belsito, D, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Cancellieri, MA, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Fryer, AD, Jones, L, Joshi, K, Kumar, M, Lapczynski, A, Lavelle, M, Lee, I, Liebler, DC, Moustakas, H, Na, M, Penning, TM, Ritacco, G, Romine, J, Sadekar, N, Schultz, TW, Selechnik, D, Siddiqi, F, Sipes, IG, Sullivan, G, Thakkar, Y & Tokura, Y 2021, 'RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7', Food and Chemical Toxicology, vol. 153, 112181. https://doi.org/10.1016/j.fct.2021.112181

TY - JOUR

T1 - RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7

AU - Api, A. M.

AU - Belsito, D.

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 - Jones, L.

AU - Joshi, K.

AU - Kumar, M.

AU - Lapczynski, A.

AU - Lavelle, M.

AU - Lee, I.

AU - Liebler, D. C.

AU - Moustakas, H.

AU - Na, M.

AU - Penning, T. M.

AU - Ritacco, G.

AU - Romine, J.

AU - Sadekar, N.

AU - Schultz, T. W.

AU - Selechnik, D.

AU - Siddiqi, F.

AU - Sipes, I. G.

AU - Sullivan, G.

AU - Thakkar, Y.

AU - Tokura, Y.

PY - 2021

Y1 - 2021

N2 - The existing information supports the use of this material as described in this safety assessment. Hexadeca-1,5-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog hydroxynonanoic acid, δ-lactone (CAS # 3301-94-8) show that hexadeca-1,5-lactone is not expected to be genotoxic. Data from analog δ-decalactone (CAS # 705-86-2) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog δ-octalactone (CAS # 698-76-0) show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexadeca-1,5-lactone is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). For the hazard assessment based on the screening data, hexadeca-1,5-lactone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Hexadeca-1,5-lactone could not be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.

AB - The existing information supports the use of this material as described in this safety assessment. Hexadeca-1,5-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog hydroxynonanoic acid, δ-lactone (CAS # 3301-94-8) show that hexadeca-1,5-lactone is not expected to be genotoxic. Data from analog δ-decalactone (CAS # 705-86-2) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog δ-octalactone (CAS # 698-76-0) show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexadeca-1,5-lactone is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). For the hazard assessment based on the screening data, hexadeca-1,5-lactone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Hexadeca-1,5-lactone could not be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.

KW - And reproductive toxicity

KW - Developmental

KW - Environmental safety

KW - Genotoxicity

KW - Local respiratory toxicity

KW - Phototoxicity/photoallergenicity

KW - Repeated dose

KW - Skin sensitization

U2 - 10.1016/j.fct.2021.112181

DO - 10.1016/j.fct.2021.112181

M3 - Article

C2 - 33839218

AN - SCOPUS:85104088522

SN - 0278-6915

VL - 153

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 112181

ER -

RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7

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