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CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Persistence and bioaccumulation (moderate), Ecotoxicology (low), and Irritation (skin, eyes, or lungs) (high)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is HIGH

Products with this Ingredient

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facial moisturizer/treatment15 products
moisturizer with SPF10 products
serums & essences9 products
foundation8 products
body oil7 products
moisturizer7 products
facial cleanser7 products
mask5 products
exfoliant/scrub5 products
shampoo5 products
beach & sport sunscreen4 products
body wash/cleanser4 products
toners/astringents4 products
hand cream3 products
baby oil3 products
liquid hand soap3 products
toothpaste3 products
hair styling aide3 products
anti-aging2 products
bar soap2 products
conditioner2 products
mouthwash2 products
baby sunscreen2 products
hair treatment/serum2 products
tooth whitening2 products
body spray1 products
fragrance for women1 products
bubble bath1 products
baby lotion1 products
bath oil/salts/soak1 products
beard oil1 products
around-eye cream1 products
vapor rubs1 products
detangler1 products

Allergies/immunotoxicity

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Concern Reference
Known human any toxicant or allergenOpinion on Frangrance allergens in cosmetics (2011), EU Cosmetics Directive
Possible human any toxicant or allergenEuropean Union 2015. Banned and Restricted Fragrances. Appears as: listid: EUFRAG-046; Chemical_Name: Limonene; Synonyms: d-Limonene;
Human any toxicant or allergen - strong evidenceEnvironmental Protection Agency (EPA) 2018. Safer Chemical Ingredients List (2018-02-28). Appears as: CAS: 5989-27-5; List Name: d-Limonene; TSCA Chemical Name: CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-, (4R)-
Limited evidence of any toxicity or allergiesEU GHS Hazard Labeling Codes 2015. Classification & Labelling (Skin Deep®). Appears as: listid: 601-029-00-7-61; Chemical_Name: DIPENTENE; Synonyms: limonene; [1] ; (R)-p-mentha-1,8-diene; ; d-limonene; [2] ; (S)-p-mentha-1,8-diene; ; l-limonene; [3] ; trans-1-methyl-4-(1-methylvinyl)cyclohexene; [4] ; (±)-1-methyl-4-(1-methylvinyl)cyclohexene [5]; CAS: 5989-27-5
Limited evidence of any toxicity or allergiesUS. National Library of Medicine,. 2015. Haz-Map®. Appears as: listid: HMAP-0695-1; Chemical_Name: d-Limonene; ; CAS: 5989-27-5
Limited evidence of any toxicity or allergiesEuropean Chemicals Agency (ECHA) 2018. GHS Data from ECHA Website. Appears as: chemical_names: Orange, sour, ext.; (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; -; Bitter Orange essential oil; Bitter Orange Oil; citrus aurantium amara extract; Citrus aurantium amara peel oil; Citrus aurantium es; cas_numbers: 8014-17-3, 8016-38-4, 68916-04-1, 72968-50-4

Irritation (skin, eyes, or lungs)

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Concern Reference
Classified as any irritantEU GHS Hazard Labeling Codes 2015. Classification & Labelling (Skin Deep®). Appears as: listid: 601-029-00-7-61; Chemical_Name: DIPENTENE; Synonyms: limonene; [1] ; (R)-p-mentha-1,8-diene; ; d-limonene; [2] ; (S)-p-mentha-1,8-diene; ; l-limonene; [3] ; trans-1-methyl-4-(1-methylvinyl)cyclohexene; [4] ; (±)-1-methyl-4-(1-methylvinyl)cyclohexene [5]; CAS: 5989-27-5
Human any irritant - moderate evidenceInternational Fragrance Association (IFRA) 2015. IFRA Codes & Standards. Appears as: listid: IFRA-029; Chemical_Name: Bitter Orange Peel Oil Expressed; Synonyms: Orange Peel Oil, Bitter (Citrus aurantium L. subsp amara L.)Bitter orange oil (Citrus aurantium L. subsp. amara L.)Citrus aurantium peel oil Curacao peel oil (Citrus aurantium L.) Daidai peel oil (Citrus aurantium L.); CAS: 68916-04-1; Classification: Restricted

Persistence and bioaccumulation

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Concern Reference
Persistent, bioaccumulative in wildlifeOSPAR Comission 2015. OSPAR PBTs - Substances of Possible Concern. Appears as: listid: PBT-OSPAR-249; Chemical_Name: (4R)-CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-; Synonyms: CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-, (4R)-; CAS: 5989-27-5
Not suspected to be persistentEnvironment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05949; Chemical_Name: Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (R)-; ; CAS: 5989-27-5
Not suspected to be bioaccumulativeEnvironment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05949; Chemical_Name: Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (R)-; ; CAS: 5989-27-5

Developmental/reproductive toxicity

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Concern Reference
One or more animal studies show any effects at high doses1977 Studies on d-limonene as a gallstone solubilizer (VII) Effects on development of mouse fetuses and offsprings. Oyo Yakuri 13(6), 863-873.

Ecotoxicology

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Concern Reference
Wildlife and environmental toxicityEU GHS Hazard Labeling Codes 2015. Classification & Labelling (Skin Deep®). Appears as: listid: 601-029-00-7-61; Chemical_Name: DIPENTENE; Synonyms: limonene; [1] ; (R)-p-mentha-1,8-diene; ; d-limonene; [2] ; (S)-p-mentha-1,8-diene; ; l-limonene; [3] ; trans-1-methyl-4-(1-methylvinyl)cyclohexene; [4] ; (±)-1-methyl-4-(1-methylvinyl)cyclohexene [5]; CAS: 5989-27-5
Suspected to be an environmental toxinEnvironment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05949; Chemical_Name: Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (R)-; ; CAS: 5989-27-5
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Data gaps

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Concern Reference
Insufficient data to determine safetyFinal report 12/2016 available from CIR
4 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Miscellaneous

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Concern Reference
Occupational hazards related to handlingEU GHS Hazard Labeling Codes 2015. Classification & Labelling (Skin Deep®). Appears as: listid: 601-029-00-7-61; Chemical_Name: DIPENTENE; Synonyms: limonene; [1] ; (R)-p-mentha-1,8-diene; ; d-limonene; [2] ; (S)-p-mentha-1,8-diene; ; l-limonene; [3] ; trans-1-methyl-4-(1-methylvinyl)cyclohexene; [4] ; (±)-1-methyl-4-(1-methylvinyl)cyclohexene [5]; CAS: 5989-27-5

Cancer

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Concern Reference
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsIARC 2015. IRAC Carcinogens (Skin Deep®). Appears as: listid: IARC-653; Chemical_Name: d-Limonene; ; CAS: 5989-27-5

Multiple, additive exposure sources

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Concern Reference
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Use restrictions

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Concern Reference
Restricted in cosmetics - labeling requirement for allergensEU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-27937; Chemical_Name: d-Limonene (CAS No 5989-27-5); ; CAS: 5989-27-5

Data Sources

  • Opinion on Frangrance allergens in cosmetics (2011), EU Cosmetics Directive
  • European Union 2015. Banned and Restricted Fragrances. Appears as: listid: EUFRAG-046; Chemical_Name: Limonene; Synonyms: d-Limonene;
  • Environmental Protection Agency (EPA) 2018. Safer Chemical Ingredients List (2018-02-28). Appears as: CAS: 5989-27-5; List Name: d-Limonene; TSCA Chemical Name: CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-, (4R)-
  • EU GHS Hazard Labeling Codes 2015. Classification & Labelling (Skin Deep®). Appears as: listid: 601-029-00-7-61; Chemical_Name: DIPENTENE; Synonyms: limonene; [1] ; (R)-p-mentha-1,8-diene; ; d-limonene; [2] ; (S)-p-mentha-1,8-diene; ; l-limonene; [3] ; trans-1-methyl-4-(1-methylvinyl)cyclohexene; [4] ; (±)-1-methyl-4-(1-methylvinyl)cyclohexene [5]; CAS: 5989-27-5
  • US. National Library of Medicine,. 2015. Haz-Map®. Appears as: listid: HMAP-0695-1; Chemical_Name: d-Limonene; ; CAS: 5989-27-5
  • European Chemicals Agency (ECHA) 2018. GHS Data from ECHA Website. Appears as: chemical_names: Orange, sour, ext.; (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; -; Bitter Orange essential oil; Bitter Orange Oil; citrus aurantium amara extract; Citrus aurantium amara peel oil; Citrus aurantium es; cas_numbers: 8014-17-3, 8016-38-4, 68916-04-1, 72968-50-4
  • International Fragrance Association (IFRA) 2015. IFRA Codes & Standards. Appears as: listid: IFRA-029; Chemical_Name: Bitter Orange Peel Oil Expressed; Synonyms: Orange Peel Oil, Bitter (Citrus aurantium L. subsp amara L.)Bitter orange oil (Citrus aurantium L. subsp. amara L.)Citrus aurantium peel oil Curacao peel oil (Citrus aurantium L.) Daidai peel oil (Citrus aurantium L.); CAS: 68916-04-1; Classification: Restricted
  • OSPAR Comission 2015. OSPAR PBTs - Substances of Possible Concern. Appears as: listid: PBT-OSPAR-249; Chemical_Name: (4R)-CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-; Synonyms: CYCLOHEXENE, 1-METHYL-4-(1-METHYLETHENYL)-, (4R)-; CAS: 5989-27-5
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05949; Chemical_Name: Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (R)-; ; CAS: 5989-27-5
  • 1977 Studies on d-limonene as a gallstone solubilizer (VII) Effects on development of mouse fetuses and offsprings. Oyo Yakuri 13(6), 863-873.
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • Final report 12/2016 available from CIR
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • IARC 2015. IRAC Carcinogens (Skin Deep®). Appears as: listid: IARC-653; Chemical_Name: d-Limonene; ; CAS: 5989-27-5
  • FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
  • EU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-27937; Chemical_Name: d-Limonene (CAS No 5989-27-5); ; CAS: 5989-27-5

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