SODIUM SACCHARIN

Flavoring Agent; Fragrance Ingredient; MASKING; ORAL CARE  

Also listed as

1,2-BENZISOTHIAZOL-3 (2H) -ONE, 1,1-DIOXIDE, SODIUM SALT, DIHYDRATE; O-BENZOYLSULFIMIDE SODIUM SALT; CRYSTALLOSE; 1,1-DIOXIDE-1,2-BENZISOTHIAZOL-3 (2H) -ONE, SODIUM SALT, DIHYDRATE; SACCHARINE, SODIUM SALT; SACCHARIN SODIUM; SODUIM SA CCHARINE; DIHYDRATE 1,2-BENZISOTHIAZOL-3 (2H) -ONE, 1,1-DIOXIDE, SODIUM SALT; DIHYDRATE 1,1-DIOXIDE-1,2-BENZISOTHIAZOL-3 (2H) -ONE, SODIUM SALT; SODIUM SALT SACCHARINE; SODIUM SALT DIHYDRATE 1,2-BENZISOTHIAZOL-3 (2H) -ONE, 1,1-DIOXIDE


Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

This ingredient:
yes, weakCancer
yes, weakDevelopmental/reproductive toxicity
noViolations, restrictions & warnings
noAllergies/immunotoxicity
noContamination concerns
noOther moderate concerns for this ingredient:
Neurotoxicity
noLesser or emerging concerns for this ingredient:
Endocrine disruption, Organ system toxicity (non-reproductive), Data gaps
 
See products containing SODIUM SACCHARIN

About SODIUM SACCHARIN: Sodium Saccharin is the organic compound.

SODIUM SACCHARIN has reported used in the following product types: toothpaste (503); tooth whitening (258); mouthwash (130); lip gloss (118); lip plumper (59); lipstick (55); lip balm (53); oral pain relief (46); sunscreen: lip balm (26); breath fresheners (17)


Neurotoxicity

type of concern product conditions reference
One or more animal studies show brain and nervous system effects at very low doses    RTECS®- Journal of Pharmacology and Experimental Therapeutics 2002
show more

Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Mutation Research 1987
show more

Endocrine disruption

type of concern product conditions reference
One or more animal studies show endocrine system disruption at high doses    RTECS®- National Technical Information Service

Developmental/reproductive toxicity

type of concern product conditions reference
One or more animal studies show reproductive effects at high doses    RTECS®- Food and Chemical Toxicology 1988
show more

Organ system toxicity (non-reproductive)

type of concern product conditions reference
One or more animal studies show broad systemic effects at high doses (low dose studies may be unavailable for this ingredient)    RTECS®- Food and Cosmetics Toxicology 1968
show more

Data gaps

type of concern product conditions reference
Not assessed for safety in cosmetics by industry panel  
267 studies on toxicity in PubMed see search results ->   PubMed

Ecotoxicology

type of concern product conditions reference
Not suspected to be an environmental toxin     Environmental Canada Domestic Substance List

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be persistent     Environmental Canada Domestic Substance List
show more

Multiple, additive exposure sources

type of concern product conditions reference
Designated as safe for general or specific, limited use in food   FDA Food Additive Status
Designated as safe for general or specific, limited use in food   FDA Everything Added to Food



Government, industry, academic studies and classifications

government/industry list/academic study appears on list as classification(s)
FDA Food Additive StatusSACCHARIN• Food additive: non-nutritive sweetener
• REG/ITEM
• less than 12 milligram(s) /fl oz - In bevs and fruit juice drinks and bases or mixes - CFR180.37
• less than 20 mg/teaspoonful of sugar sweetening equivalency - In sugar substitutes for cooking or table use - CFR180.37
• less than 30 mg/serving - In processed foods -180.37
• refers to part number under Title 21 Code of Federal Regulations 145
FDA Everything Added to FoodSACCHARIN, SODIUM SALT• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List1,2-BENZISOTHIAZOL-3(2H)-ONE, 1,1-DIOXIDE, SODIUM SALT•This chemical was NOT flagged by CEPA for further attention.
IFRA Fragrance Ingredient ListSACCHARINE, SODIUM SALT•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale 1980SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Damage (mouse ipr)
RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale 1980SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Damage (mouse ipr)
RTECS®- British Journal of Cancer 1979SODIUM SACCHARIN• kidney or renal system - Changes in blood vessels or in circulation of kidney (rat TD)
• cancer - kidney or renal system tumor formations - equivocal (rat TD)
RTECS®- Bulletin of Environmental Contamination and Toxicology 1974SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse ipr)
• mutagenic - Positive mutation assay: Dominant Lethal Strain (mouse ipr)
RTECS®- Bulletin of Environmental Contamination and Toxicology 1974SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse ipr)
• mutagenic - Positive mutation assay: Dominant Lethal Strain (mouse ipr)
RTECS®- Cancer Letters (Shannon, Ireland) 1986SODIUM SACCHARIN• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (rat orl)
RTECS®- Cancer Letters (Shannon, Ireland) 1986SODIUM SACCHARIN• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (rat orl)
RTECS®- Cancer Research 1977SODIUM SACCHARIN• cancer - kidney or renal system neoplasms (rat TD)
• mutagenic - skin neoplasms (rat TD)
RTECS®- Cancer Research 1980SODIUM SACCHARIN• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (rat lvr)
RTECS®- Cancer Research 1980SODIUM SACCHARIN• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (rat lvr)
RTECS®- Chemico-Biological Interactions 1975SODIUM SACCHARIN• cancer - kidney or renal system tumor formations - equivocal (rat TD)
RTECS®- Environmental Mutagenesis 1979SODIUM SACCHARIN• mutagenic - Positive mutation assay: Sister Chromatid Exchange ( human leu)
RTECS®- Food and Chemical Toxicology 1988SODIUM SACCHARIN• reproductive - Growth statistics (rat TDLo)
RTECS®- Food and Chemical Toxicology 1991SODIUM SACCHARIN• reproductive - Growth statistics (rat TDLo)
RTECS®- Food and Cosmetics Toxicology 1968SODIUM SACCHARIN• broad systemic - Broad systemic toxicity (rat LD50)
RTECS®- Gann 1983SODIUM SACCHARIN• cancer - kidney or renal system tumors (rat TDLo)
RTECS®- Hereditas (Lund, Sweden) 1972SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Hereditas (Lund, Sweden) 1972SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Indian Journal of Medical Research 1972SODIUM SACCHARIN• reproductive - Fetal death (mouse TDLo)
RTECS®- Journal of Environmental Pathology and Toxicology 1979SODIUM SACCHARIN• reproductive - Male fertility index (mouse TDLo)
RTECS®- Journal of Pharmacology and Experimental Therapeutics 2002SODIUM SACCHARIN• brain and nervous system - Changes in psychophysiological tests (monkey TDLo)
RTECS®- Journal of Toxicological Sciences 1981SODIUM SACCHARIN• metabolic - Weight loss or decreased weight gain (rat TDLo)
• kidney or renal system - Other changes (rat TDLo)
• kidney or renal system - Other changes in urine composition (rat TDLo)
RTECS®- Mutation Research 1987SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Inhibition ( human fbr)
RTECS®- Mutation Research 1988SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Mammalian Somatic Cells ( human emb)
RTECS®- Mutation Research 1975SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (Salmonella typhimurium )
• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human leu)
• mutagenic - Positive mutation assay: Dominant Lethal Strain (mouse orl)
• mutagenic - Positive mutation assay: Sex Chromosome Loss and Nondisjunction (Drosophila melanogaster par)
• mutagenic - Positive mutation assay: sperm (mouse ipr)
RTECS®- Mutation Research 1977SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Mutation Research 2002SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Damage (mouse orl)
RTECS®- Mutation Research 2004SODIUM SACCHARIN• mutagenic - Positive mutation assay: Morphological Transform (mouse oth)
RTECS®- Mutation Research 1979SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (mouse lym)
RTECS®- Mutation Research 1979SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (Saccharomyces cerevisiae )
• mutagenic - Positive mutation assay: Gene Conversion and Mitotic Recombination (Saccharomyces cerevisiae )
RTECS®- Mutation Research 1987SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Inhibition ( human fbr)
RTECS®- Mutation Research 1988SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Mammalian Somatic Cells ( human emb)
RTECS®- Mutation Research 1975SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (Salmonella typhimurium )
• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human leu)
• mutagenic - Positive mutation assay: Dominant Lethal Strain (mouse orl)
• mutagenic - Positive mutation assay: Sex Chromosome Loss and Nondisjunction (Drosophila melanogaster par)
• mutagenic - Positive mutation assay: sperm (mouse ipr)
RTECS®- Mutation Research 1977SODIUM SACCHARIN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Mutation Research 2002SODIUM SACCHARIN• mutagenic - Positive mutation assay: DNA Damage (mouse orl)
RTECS®- Mutation Research 2004SODIUM SACCHARIN• mutagenic - Positive mutation assay: Morphological Transform (mouse oth)
RTECS®- Mutation Research 1979SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (mouse lym)
RTECS®- Mutation Research 1979SODIUM SACCHARIN• mutagenic - Positive mutation assay: Mutation in Micro-organism (Saccharomyces cerevisiae )
• mutagenic - Positive mutation assay: Gene Conversion and Mitotic Recombination (Saccharomyces cerevisiae )
RTECS®- National Technical Information Service SODIUM SACCHARIN• reproductive - Behavioral (mouse TDLo)
• endocrine system - Death in the "U" data type field (mouse TDLo)
• reproductive - Live birth index (mouse TDLo)
• brain and nervous system - Fluid intake (mouse TDLo)
RTECS®- Science of Biology Journal 1975SODIUM SACCHARIN• mutagenic - Positive mutation assay: Sex Chromosome Loss and Nondisjunction (Drosophila melanogaster orl)
RTECS®- Science 1970SODIUM SACCHARIN• cancer - kidney or renal system neoplasms (mouse TDLo)
• cancer - Tumors at site of application (mouse TDLo)
RTECS®- Toxicology and Applied Pharmacology 1980SODIUM SACCHARIN• cancer - kidney or renal system tumors (rat TD)
RTECS®- Toxicology Letters 1983SODIUM SACCHARIN• reproductive - Male fertility index (mouse TDLo)
RTECS®- Toxicology Letters 1981SODIUM SACCHARIN• immune system - Decrease in humoral immune response (rat TDLo)
RTECS®- United States Patent Document 9913SODIUM SACCHARIN• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS®- Yakkyoku 1981SODIUM SACCHARIN• broad systemic - Broad systemic toxicity (rabbit LDLo)

references

government/industry list/academic study reference
FDA Food Additive StatusFDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.
FDA Everything Added to FoodFDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
Environmental Canada Domestic Substance ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
IFRA Fragrance Ingredient ListIFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25
RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale 1980RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale. (Casa Editrice Idelson, Via A. de Gasperi, 55, 80133 Naples, Italy) V.2- 56,2486,1980
RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale 1980RTECS®- Bolletino della Societe Italiana di Biologia Sperimentale. (Casa Editrice Idelson, Via A. de Gasperi, 55, 80133 Naples, Italy) V.2- 1927- 56,2486,1980
RTECS®- British Journal of Cancer 1979RTECS®- British Journal of Cancer. (Macmillan Press Ltd., Houndmills, Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- 39,355,1979
RTECS®- Bulletin of Environmental Contamination and Toxicology 1974RTECS®- Bulletin of Environmental Contamination and Toxicology. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 1966- 12,186,1974
RTECS®- Bulletin of Environmental Contamination and Toxicology 1974RTECS®- Bulletin of Environmental Contamination and Toxicology. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 12,186,1974
RTECS®- Cancer Letters (Shannon, Ireland) 1986RTECS®- Cancer Letters (Shannon, Ireland). (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 33,119,1986
RTECS®- Cancer Letters (Shannon, Ireland) 1986RTECS®- Cancer Letters (Shannon, Ireland). (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 1975- 33,119,1986
RTECS®- Cancer Research 1977RTECS®- Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- 37,2943,1977
RTECS®- Cancer Research 1980RTECS®- Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- 40,4541,1980
RTECS®- Cancer Research 1980RTECS®- Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 40,4541,1980
RTECS®- Chemico-Biological Interactions 1975RTECS®- Chemico-Biological Interactions. (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 1969- 11,225,1975
RTECS®- Environmental Mutagenesis 1979RTECS®- Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For publisher information, see EMMUEG. 1,177,1979
RTECS®- Food and Chemical Toxicology 1988RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 26,899,1988
RTECS®- Food and Chemical Toxicology 1991RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 29,657,1991
RTECS®- Food and Cosmetics Toxicology 1968RTECS®- Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. 6,313,1968
RTECS®- Gann 1983RTECS®- Gann. Japanese Journal of Cancer Research. (Tokyo, Japan) V.1-75, 1907-84. For publisher information, see JJCREP. 74,8,1983
RTECS®- Hereditas (Lund, Sweden) 1972RTECS®- Hereditas (Lund, Sweden). (Gjoerloffsgatan 121, S-261 34 Landskrona, Sweden) V.1- 1947- 70,271,1972
RTECS®- Hereditas (Lund, Sweden) 1972RTECS®- Hereditas (Lund, Sweden). (Gjoerloffsgatan 121, S-261 34 Landskrona, Sweden) V.1- 70,271,1972
RTECS®- Indian Journal of Medical Research 1972RTECS®- Indian Journal of Medical Research. (Indian Council of Medical Research, Ansari Nagar, New Delhi 110 029, India) V.1- 1913- 60,599,1972
RTECS®- Journal of Environmental Pathology and Toxicology 1979RTECS®- Journal of Environmental Pathology and Toxicology. (Park Forest South, IL) V.1-5(3), 1977-81(?). For publisher information, see JEPOEC. 2(4),1047,1979
RTECS®- Journal of Pharmacology and Experimental Therapeutics 2002RTECS®- Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- 301,993,2002
RTECS®- Journal of Toxicological Sciences 1981RTECS®- Journal of Toxicological Sciences. (Japanese Soc. of Toxicological Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku, Tokyo 113, Japan) V.1- 1976- 6,246,1981
RTECS®- Mutation Research 1987RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 183,89,1987
RTECS®- Mutation Research 1988RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 209,13,1988
RTECS®- Mutation Research 1975RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 32,81,1975
RTECS®- Mutation Research 1977RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 48,337,1977
RTECS®- Mutation Research 2002RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 519,103,2002
RTECS®- Mutation Research 2004RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 557,191,2004
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 59,61,1979
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 67,215,1979
RTECS®- Mutation Research 1987RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 183,89,1987
RTECS®- Mutation Research 1988RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 209,13,1988
RTECS®- Mutation Research 1975RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 32,81,1975
RTECS®- Mutation Research 1977RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 48,337,1977
RTECS®- Mutation Research 2002RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 519,103,2002
RTECS®- Mutation Research 2004RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 557,191,2004
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 59,61,1979
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 67,215,1979
RTECS®- National Technical Information Service RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. #PB85188258/AS
RTECS®- Science of Biology Journal 1975RTECS®- Science of Biology Journal. (Springfield, IL) V.1-4, 1975-78(?). Discontinued. 1,77,1975
RTECS®- Science 1970RTECS®- Science. (American Assoc. for the Advancement of Science, 1333 H St., NW, Washington, DC 20005) V.1- 1895- 168,1238,1970
RTECS®- Toxicology and Applied Pharmacology 1980RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 52,113,1980
RTECS®- Toxicology Letters 1983RTECS®- Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- 19,267,1983
RTECS®- Toxicology Letters 1981RTECS®- Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- 8,1,1981
RTECS®- United States Patent Document 9913RTECS®- United States Patent Document. (U.S. Patent Office, Box 9, Washington, DC 20231) #4869913
RTECS®- Yakkyoku 1981RTECS®- Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- 32,1367,1981

"RTECS®" is a United States trademark owned and licensed under authority of the U.S. Government, by and through MDL Information Systems, Inc.

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