The Experts below are selected from a list of 309 Experts worldwide ranked by ideXlab platform

Anne Marie Api - One of the best experts on this subject based on the ideXlab platform.

  • RIFM fragrance ingredient safety assessment, cyclohexanol, CAS Registry Number 108-93-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary The existing information supports the use of this material as described in this safety assessment. Cyclohexanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that cyclohexanol is not genotoxic. Data on cyclohexanol provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. Data show that there are no safety concerns for cyclohexanol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; cyclohexanol 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, and the exposure to cyclohexanol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; cyclohexanol 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

  • rifm fragrance ingredient safety assessment glyceryl monooleate CAS Registry number 111 03 5
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate 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, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are

  • rifm fragrance ingredient safety assessment p tolualdehyde CAS Registry number 104 87 0
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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

  • RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and 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; 3-octanol 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). The environmental endpoints were evaluated; 3-octanol 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

  • rifm fragrance ingredient safety assessment isobutyric acid CAS Registry number 79 31 2
    Food and Chemical Toxicology, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    There are insufficient toxicity data on isobutyric acid (CAS # 79-31-2). Hence, in silico evaluation was conducted to determine read-across analogs for this material. Based on structural similarity, reactivity, physical–chemical properties, and expert judgment, propionic acid (CAS # 79-09-4) and isovaleric acid (CAS # 503-74-2) were identified as read-across analogs with sufficient data for toxicological evaluation.

Donald V. Belsito - One of the best experts on this subject based on the ideXlab platform.

  • RIFM fragrance ingredient safety assessment, cyclohexanol, CAS Registry Number 108-93-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary The existing information supports the use of this material as described in this safety assessment. Cyclohexanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that cyclohexanol is not genotoxic. Data on cyclohexanol provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. Data show that there are no safety concerns for cyclohexanol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; cyclohexanol 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, and the exposure to cyclohexanol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; cyclohexanol 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

  • rifm fragrance ingredient safety assessment glyceryl monooleate CAS Registry number 111 03 5
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate 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, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are

  • rifm fragrance ingredient safety assessment p tolualdehyde CAS Registry number 104 87 0
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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

  • RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and 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; 3-octanol 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). The environmental endpoints were evaluated; 3-octanol 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

  • rifm fragrance ingredient safety assessment isobutyric acid CAS Registry number 79 31 2
    Food and Chemical Toxicology, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    There are insufficient toxicity data on isobutyric acid (CAS # 79-31-2). Hence, in silico evaluation was conducted to determine read-across analogs for this material. Based on structural similarity, reactivity, physical–chemical properties, and expert judgment, propionic acid (CAS # 79-09-4) and isovaleric acid (CAS # 503-74-2) were identified as read-across analogs with sufficient data for toxicological evaluation.

Magnus Bruze - One of the best experts on this subject based on the ideXlab platform.

  • RIFM fragrance ingredient safety assessment, cyclohexanol, CAS Registry Number 108-93-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary The existing information supports the use of this material as described in this safety assessment. Cyclohexanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that cyclohexanol is not genotoxic. Data on cyclohexanol provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. Data show that there are no safety concerns for cyclohexanol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; cyclohexanol 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, and the exposure to cyclohexanol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; cyclohexanol 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

  • rifm fragrance ingredient safety assessment glyceryl monooleate CAS Registry number 111 03 5
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate 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, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are

  • rifm fragrance ingredient safety assessment p tolualdehyde CAS Registry number 104 87 0
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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

  • RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and 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; 3-octanol 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). The environmental endpoints were evaluated; 3-octanol 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

  • rifm fragrance ingredient safety assessment isobutyric acid CAS Registry number 79 31 2
    Food and Chemical Toxicology, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    There are insufficient toxicity data on isobutyric acid (CAS # 79-31-2). Hence, in silico evaluation was conducted to determine read-across analogs for this material. Based on structural similarity, reactivity, physical–chemical properties, and expert judgment, propionic acid (CAS # 79-09-4) and isovaleric acid (CAS # 503-74-2) were identified as read-across analogs with sufficient data for toxicological evaluation.

S. La Cava - One of the best experts on this subject based on the ideXlab platform.

  • rifm fragrance ingredient safety assessment linalyl cinnamate CAS Registry number 78 37 5
    Food and Chemical Toxicology, 2016
    Co-Authors: Donald V. Belsito, Magnus Bruze, Peter Calow, Wolfgang Dekant, L Kromidas, S. La Cava, A D Fryer, S Bhatia, M L Dagli, J Lalko
    Abstract:

    The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental toxicity endpoint was completed using linalool (CAS # 78-70-6), dehydrolinalool (CAS # 29171-20-8) and cinnamic acid (CAS # 621-82-9) as suitable read across analogs, which provided a MOE > 100. The repeated dose toxicity endpoint was completed using data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.

  • rifm fragrance ingredient safety assessment α ionone CAS Registry number 127 41 3
    Food and Chemical Toxicology, 2016
    Co-Authors: Anne Marie Api, Donald V. Belsito, Magnus Bruze, Peter Calow, Wolfgang Dekant, L Kromidas, A D Fryer, S Bhatia, M L Dagli, S. La Cava
    Abstract:

    The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 10 mg/kg/day. A dietary 90-day subchronic toxicity study conducted in rats resulted in a MOE of 182 while assuming 100% absorption from skin contact and inhalation. A MOE of >100 is deemed acceptable.

  • RIFM fragrance ingredient safety assessment, 2-methylundecanol, CAS Registry Number 10522-26-6.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2016
    Co-Authors: Anne Marie Api, Donald V. Belsito, Magnus Bruze, Peter Calow, Wolfgang Dekant, L Kromidas, A D Fryer, S Bhatia, M L Dagli, S. La Cava
    Abstract:

    This material was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analogs 2-butyloctan-1-ol (CAS # 3913-02-8) and 2-ethyl-1-hexanol (CAS # 104-76-7) show that this material is not genotoxic nor does it have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The repeated dose toxicity endpoint was completed using 2-ethyl-1-hexanol (CAS # 104-76-7) and 1-heptanol, 2-propyl (CAS # 10042-59-8) as suitable read across analogs, which provided a MOE > 100. The developmental toxicity endpoint was completed using 2-ethyl-1-hexanol (CAS # 104-76-7) as a suitable read across analog, which provided a MOE > 100 The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.

  • RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2
    Food and Chemical Toxicology, 2016
    Co-Authors: Anne Marie Api, Maria Lúcia Zaidan Dagli, Donald V. Belsito, Magnus Bruze, Peter Calow, Wolfgang Dekant, L Kromidas, A D Fryer, S Bhatia, S. La Cava
    Abstract:

    This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework

  • RIFM fragrance ingredient safety assessment, isoeugenol, CAS Registry Number 97-54-1.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2015
    Co-Authors: Anne Marie Api, Maria Lúcia Zaidan Dagli, Donald V. Belsito, Magnus Bruze, Peter Calow, Wolfgang Dekant, L Kromidas, A D Fryer, S Bhatia, S. La Cava
    Abstract:

    The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 37.5 mg/kg/day. A gavage 13-week subchronic toxicity study conducted in mice resulted in a MOE of 5769 while considering 38.4% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.

M Date - One of the best experts on this subject based on the ideXlab platform.

  • RIFM fragrance ingredient safety assessment, cyclohexanol, CAS Registry Number 108-93-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary The existing information supports the use of this material as described in this safety assessment. Cyclohexanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that cyclohexanol is not genotoxic. Data on cyclohexanol provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. Data show that there are no safety concerns for cyclohexanol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; cyclohexanol 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, and the exposure to cyclohexanol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; cyclohexanol 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

  • rifm fragrance ingredient safety assessment glyceryl monooleate CAS Registry number 111 03 5
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate 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, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are

  • rifm fragrance ingredient safety assessment p tolualdehyde CAS Registry number 104 87 0
    Food and Chemical Toxicology, 2021
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    Summary The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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

  • RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Maria Lúcia Zaidan Dagli, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M Date
    Abstract:

    Abstract Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and 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; 3-octanol 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). The environmental endpoints were evaluated; 3-octanol 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

  • rifm fragrance ingredient safety assessment isobutyric acid CAS Registry number 79 31 2
    Food and Chemical Toxicology, 2020
    Co-Authors: Anne Marie Api, M A Cancellieri, Donald V. Belsito, S. Biserta, D. Botelho, Magnus Bruze, G.a. Burton, J. Buschmann, M L Dagli, M Date
    Abstract:

    There are insufficient toxicity data on isobutyric acid (CAS # 79-31-2). Hence, in silico evaluation was conducted to determine read-across analogs for this material. Based on structural similarity, reactivity, physical–chemical properties, and expert judgment, propionic acid (CAS # 79-09-4) and isovaleric acid (CAS # 503-74-2) were identified as read-across analogs with sufficient data for toxicological evaluation.