NOAEL Studies Cosmetic Ingredient

Xanthan Gum NOAEL Studies

INCI: XANTHAN GUM

CAS: 11138-66-2

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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CIR Safety Assessment 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =0.25 g/kg dog oral 12 weeks oral toxicity 5; 2; 61, p.27
CIR Safety Assessment NOAEL =1 % - oral - oral toxicity 15; 5; 65, p.28
CIR Safety Assessment NOAEL =5 % rat oral 28 days oral toxicity 2; 28; 0, 1, 2, p.27
CIR Safety Assessment NOAEL =5 g/kg rabbit - - developmental toxicity 2; 28; 1, 1, p.32
CIR Safety Assessment NOAEL =10 % rat oral 62 weeks oral toxicity 5; 10; 44, p.29
CIR Safety Assessment NOAEL =15 % rat oral 100 days reproductive toxicity 20; 40; 15, p.31
CIR Safety Assessment NOAEL =20 mg/kg rat oral 52 weeks oral toxicity 113; 20; 52, p.29
CIR Safety Assessment NOAEL =100 mg/kg BW/d rat oral 28 days oral toxicity 0, 2, 33; 3; 100, p.29
CIR Safety Assessment NOAEL =2000 mg/kg BW rat oral 3 months reproductive toxicity 12; 3; 0, 500, 1,000, p.28
COSMOS DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 500 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1000 mg/kg bw/day rat oral 730 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day dog oral 84 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3250 mg/kg bw/day rat oral 99 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 7500 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA LEL =214 mg/kg bw/day Human oral short-term; 10 days clinical LONG_REF=EFSA ANS (2017). Re-evaluation of xanthan gum (E 415) as a food additive. doi:10.2903/j.efsa.2017.4909.; TITLE=Re-evaluation of xanthan gum (E 415) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4909; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15625123:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_13fc3e92ef0a4e6f40b94add6d8e0e1b
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 5 g/kg rabbit - - developmental toxicity p.32
Regulatory source oral toxicity 0.25 g/kg dog oral 12 weeks oral toxicity p.27
Regulatory source oral toxicity 1 % - oral - oral toxicity p.28
Regulatory source oral toxicity 5 % rat oral 28 days oral toxicity p.27
Regulatory source oral toxicity 10 % rat oral 62 weeks oral toxicity p.29
Regulatory source oral toxicity 20 mg/kg rat oral 52 weeks oral toxicity p.29
Regulatory source oral toxicity 100 mg/kg BW/d rat oral 28 days oral toxicity p.29
Regulatory source reproductive toxicity 15 % rat oral 100 days reproductive toxicity p.31
Regulatory source reproductive toxicity 2000 mg/kg BW rat oral 3 months reproductive toxicity p.28
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier TTV12P4NEE UNII - - - structurallyDiverse -