RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6

A. M. Api; D. Belsito; D. Botelho; M. Bruze; G. A. Burton; J. Buschmann; M. L. Dagli; M. Date; W. Dekant; C. Deodhar; M. Francis; A. D. Fryer; L. Jones; K. Joshi; S. La Cava; A. Lapczynski; D. C. Liebler; D. O'Brien; A. Patel; T. M. Penning; G. Ritacco; J. Romine; N. Sadekar; D. Salvito; T. W. Schultz; I. G. Sipes; G. Sullivan; Y. Thakkar; Y. Tokura; S. Tsang

doi:10.1016/j.fct.2020.111470

RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, M. Francis, A. D. Fryer, L. Jones, K. Joshi, S. La Cava, A. Lapczynski, D. C. Liebler, D. O'Brien, A. Patel, T. M. PenningG. Ritacco, J. Romine, N. Sadekar, D. Salvito, T. W. Schultz, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura, S. Tsang

Pulmonary and Critical Care Medicine

Research output: Contribution to journal › Short survey › peer-review

Abstract

The existing information supports the use of this material as described in this safety assessment. Phenylethyl anthranilate was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from phenylethyl anthranilate and the read-across analog cinnamyl anthranilate (CAS # 87-29-6) show that phenylethyl anthranilate is not expected to be genotoxic. The skin sensitization endpoint was completed using the DST for non-reactive materials (900 μg/cm²); exposure is below the DST. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class II material, and the exposure to phenylethyl anthranilate is below the TTC (0.009 mg/kg/day and 0.47 mg/day, respectively). Data on read-across analogs phenethyl alcohol (CAS # 60-12-8) and anthranilic acid (CAS # 118-92-3) provide a calculated MOE >100 for the repeated dose and developmental toxicity endpoints. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; phenylethyl anthranilate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; phenylethyl anthranilate was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

Original language	English (US)
Article number	111470
Journal	Food and Chemical Toxicology
Volume	144
DOIs	https://doi.org/10.1016/j.fct.2020.111470
State	Published - Oct 15 2020

Keywords

Developmental, and reproductive toxicity
Environmental safety
Genotoxicity
Hototoxicity/photoallergenicity
Local respiratory toxicity
Repeated dose
Skin sensitization

ASJC Scopus subject areas

Food Science
Toxicology

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10.1016/j.fct.2020.111470

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Api, A. M., Belsito, D., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Francis, M., Fryer, A. D., Jones, L., Joshi, K., La Cava, S., Lapczynski, A., Liebler, D. C., O'Brien, D., Patel, A., ... Tsang, S. (2020). RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6. Food and Chemical Toxicology, 144, Article 111470. https://doi.org/10.1016/j.fct.2020.111470

Api, AM, Belsito, D, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Francis, M, Fryer, AD, Jones, L, Joshi, K, La Cava, S, Lapczynski, A, Liebler, DC, O'Brien, D, Patel, A, Penning, TM, Ritacco, G, Romine, J, Sadekar, N, Salvito, D, Schultz, TW, Sipes, IG, Sullivan, G, Thakkar, Y, Tokura, Y & Tsang, S 2020, 'RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6', Food and Chemical Toxicology, vol. 144, 111470. https://doi.org/10.1016/j.fct.2020.111470

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title = "RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6",

abstract = "The existing information supports the use of this material as described in this safety assessment. Phenylethyl anthranilate was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from phenylethyl anthranilate and the read-across analog cinnamyl anthranilate (CAS # 87-29-6) show that phenylethyl anthranilate is not expected to be genotoxic. The skin sensitization endpoint was completed using the DST for non-reactive materials (900 μg/cm2); exposure is below the DST. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class II material, and the exposure to phenylethyl anthranilate is below the TTC (0.009 mg/kg/day and 0.47 mg/day, respectively). Data on read-across analogs phenethyl alcohol (CAS # 60-12-8) and anthranilic acid (CAS # 118-92-3) provide a calculated MOE >100 for the repeated dose and developmental toxicity endpoints. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; phenylethyl anthranilate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; phenylethyl anthranilate was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.",

keywords = "Developmental, and reproductive toxicity, Environmental safety, Genotoxicity, Hototoxicity/photoallergenicity, Local respiratory toxicity, 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 Dagli, {M. L.} and M. Date and W. Dekant and C. Deodhar and M. Francis and Fryer, {A. D.} and L. Jones and K. Joshi and {La Cava}, S. and A. Lapczynski and Liebler, {D. C.} and D. O'Brien and A. Patel and Penning, {T. M.} and G. Ritacco and J. Romine and N. Sadekar and D. Salvito and Schultz, {T. W.} and Sipes, {I. G.} and G. Sullivan and Y. Thakkar and Y. Tokura and S. Tsang",

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year = "2020",

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doi = "10.1016/j.fct.2020.111470",

language = "English (US)",

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T1 - RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6

AU - Api, A. M.

AU - Belsito, D.

AU - Botelho, D.

AU - Bruze, M.

AU - Burton, G. A.

AU - Buschmann, J.

AU - Dagli, M. L.

AU - Date, M.

AU - Dekant, W.

AU - Deodhar, C.

AU - Francis, M.

AU - Fryer, A. D.

AU - Jones, L.

AU - Joshi, K.

AU - La Cava, S.

AU - Lapczynski, A.

AU - Liebler, D. C.

AU - O'Brien, D.

AU - Patel, A.

AU - Penning, T. M.

AU - Ritacco, G.

AU - Romine, J.

AU - Sadekar, N.

AU - Salvito, D.

AU - Schultz, T. W.

AU - Sipes, I. G.

AU - Sullivan, G.

AU - Thakkar, Y.

AU - Tokura, Y.

AU - Tsang, S.

PY - 2020/10/15

Y1 - 2020/10/15

N2 - The existing information supports the use of this material as described in this safety assessment. Phenylethyl anthranilate was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from phenylethyl anthranilate and the read-across analog cinnamyl anthranilate (CAS # 87-29-6) show that phenylethyl anthranilate is not expected to be genotoxic. The skin sensitization endpoint was completed using the DST for non-reactive materials (900 μg/cm2); exposure is below the DST. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class II material, and the exposure to phenylethyl anthranilate is below the TTC (0.009 mg/kg/day and 0.47 mg/day, respectively). Data on read-across analogs phenethyl alcohol (CAS # 60-12-8) and anthranilic acid (CAS # 118-92-3) provide a calculated MOE >100 for the repeated dose and developmental toxicity endpoints. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; phenylethyl anthranilate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; phenylethyl anthranilate was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

AB - The existing information supports the use of this material as described in this safety assessment. Phenylethyl anthranilate was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from phenylethyl anthranilate and the read-across analog cinnamyl anthranilate (CAS # 87-29-6) show that phenylethyl anthranilate is not expected to be genotoxic. The skin sensitization endpoint was completed using the DST for non-reactive materials (900 μg/cm2); exposure is below the DST. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class II material, and the exposure to phenylethyl anthranilate is below the TTC (0.009 mg/kg/day and 0.47 mg/day, respectively). Data on read-across analogs phenethyl alcohol (CAS # 60-12-8) and anthranilic acid (CAS # 118-92-3) provide a calculated MOE >100 for the repeated dose and developmental toxicity endpoints. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; phenylethyl anthranilate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; phenylethyl anthranilate was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

KW - Developmental, and reproductive toxicity

KW - Environmental safety

KW - Genotoxicity

KW - Hototoxicity/photoallergenicity

KW - Local respiratory toxicity

KW - Repeated dose

KW - Skin sensitization

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JF - Food and Chemical Toxicology

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ER -

RIFM fragrance ingredient safety assessment, phenylethyl anthranilate, CAS Registry Number 133-18-6

Abstract

Keywords

ASJC Scopus subject areas

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