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1.
  • Isaksson, M., et al. (författare)
  • Suitable test concentration of cobalt and concomitant reactivity to nickel and chromium. A multicentre study from the Swedish Contact Dermatitis Research Group
  • 2020
  • Ingår i: Contact Dermatitis. - : Federation of European Neuroscience Societies and Blackwell Publishing Ltd. - 0105-1873 .- 1600-0536.
  • Tidskriftsartikel (refereegranskat)abstract
    • Background In Sweden, cobalt chloride 0.5% has been included in the baseline series since the mid-1980s. A recent study from Stockholm showed that cobalt chloride 1% petrolatum (pet.) was more suitable than 0.5%. Cobalt chloride at 1.0% has been patch tested for decades in many European countries and around the world. Objectives To study the suitability of patch testing to cobalt 1.0% vs 0.5% and to analyze the co-occurrence of allergy to cobalt, chromium, and nickel. Results Contact allergy to cobalt was shown in 90 patients (6.6%). Eighty (5.9%) patients tested positive to cobalt 1.0%. Thirty-seven of the 90 patients (41.1%) with cobalt allergy were missed by cobalt 0.5% and 10 (0.7%) were missed by cobalt 1.0% (P < .001). No case of patch test sensitization was reported. Allergy to chromium was seen in 2.6% and allergy to nickel in 13.3%. Solitary allergy to cobalt without nickel allergy was shown in 61.1% of cobalt-positive individuals. Female patients had larger proportions of positive reactions to cobalt (P = .036) and nickel (P < .001) than males. Conclusion The results speak in favor of replacing cobalt chloride 0.5% with cobalt chloride 1.0% pet. in the Swedish baseline series, which will be done 2021.
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2.
  • Api, A. M., et al. (författare)
  • RIFM fragrance ingredient safety assessment, 2-cyclohexylcyclohexanone, CAS Registry Number 90-42-6
  • 2021
  • Ingår i: Food and Chemical Toxicology. - : Elsevier. - 0278-6915.
  • Tidskriftsartikel (refereegranskat)abstract
    • Summary: The existing information supports the use of this material as described in this safety assessment. 2-Cyclohexylcyclohexanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data and read-across to 2-tert-butylcyclohexanone (CAS # 1728-46-7) show that 2-cyclohexylcyclohexanone is not expected to be genotoxic. Data on read-across material 2-sec-butylcyclohexanone (CAS # 14765-30-1) 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 non-reactive materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 2-cyclohexylcyclohexanone 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 II material, and the exposure to 2-cyclohexylcyclohexanone is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; 2-cyclohexylcyclohexanone 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.
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4.
  • Api, A. M., et al. (författare)
  • RIFM fragrance ingredient safety assessment, 2-mercaptopropionic acid, CAS Registry Number 79-42-5
  • 2021
  • Ingår i: Food and Chemical Toxicology. - : Elsevier. - 0278-6915.
  • Tidskriftsartikel (refereegranskat)abstract
    • The existing information supports the use of this material as described in this safety assessment. 2-Mercaptopropionic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-mercaptopropionic acid is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 2-mercaptopropionic acid is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). 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; 2-mercaptopropionic acid is not expected to be phototoxic/photoallergenic. For the hazard assessment based on the screening data, 2-mercaptopropionic acid is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 2-mercaptopropionic acid was not able to be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.
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5.
  • Api, A. M., et al. (författare)
  • RIFM fragrance ingredient safety assessment, 2-propanol, 1,1′,1′,1'-(1,2-ethanediyldinitrilo)tetrakis-, CAS Registry Number 102-60-3
  • 2021
  • Ingår i: Food and Chemical Toxicology. - : Elsevier. - 0278-6915.
  • Forskningsöversikt (refereegranskat)abstract
    • Summary: The existing information supports the use of this material as described in this safety assessment.2-Propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- 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 1,1',1''-nitrilotripropan-2-ol (CAS # 122-20-3) show that 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- is not expected to be genotoxic. Data on 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints 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; 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- 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 III material, and the exposure to 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- 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.
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6.
  • Api, A. M., et al. (författare)
  • RIFM fragrance ingredient safety assessment, 2-thiophenecarboxylic acid, ethyl ester, CAS Registry Number 2810-04-0
  • 2021
  • Ingår i: Food and Chemical Toxicology. - : Elsevier. - 0278-6915.
  • Tidskriftsartikel (refereegranskat)abstract
    • The existing information supports the use of this material as described in this safety assessment. 2-Thiophenecarboxylic acid, ethyl ester was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-thiophenecarboxylic acid, ethyl ester is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class III material, and the exposure to 2-thiophenecarboxylic acid, ethyl ester is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for non-reactive materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 2-thiophenecarboxylic acid, ethyl ester is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2-thiophenecarboxylic acid, ethyl ester 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.
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10.
  • Api, A. M., et al. (författare)
  • RIFM fragrance ingredient safety assessment, 3,4,4a,5,8,8a(Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran, CAS Registry Number 72429-08-4
  • 2021
  • Ingår i: Food and Chemical Toxicology. - : Elsevier. - 0278-6915.
  • Tidskriftsartikel (refereegranskat)abstract
    • The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,4,4a, 5,8,8a (Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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.
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