NOAEL Studies Cosmetic Ingredient

Amylase NOAEL Studies

INCI: AMYLASE

CAS: 9000-90-2

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

INCHEM_WHO_jecfa_jecmono_v1042je01 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v1042je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1042je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-fifth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1042je01.pdf; row_hash=28c3515324a24a95; raw_unit=mg/kg bw; context=Table 3 Requests for revisions and additions reported to the JECFA Secretariat Substance Original text Revised text Additional information Saccharin An ADI of 0-5 mg/kg bw for saccharin and its Ca, K, Na salts was established at 41st JECFA.
INCHEM_WHO_jecfa_jecmono_v1042je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1042je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-fifth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1042je01.pdf; row_hash=28c3515324a24a95; raw_unit=mg/kg bw; context=Table 3 Requests for revisions and additions reported to the JECFA Secretariat Substance Original text Revised text Additional information Saccharin An ADI of 0-5 mg/kg bw for saccharin and its Ca, K, Na salts was established at 41st JECFA.
INCHEM_WHO_jecfa_jecmono_v1042je01 NOAEL =240 mg/kg bw/day Human; Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v1042je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-fifth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1042je01.pdf; row_hash=bd0ee5c056bfd5c4; raw_unit=mg/kg bw per day; context=2263), the NOAEL of 240 mg/kg bw per day in a 13-week gavage study in male and female rats (8) provides an adequate MOE (2400) relative to the SPET estimate of 6000 ug/day (or 100 ug/kg bw per day for a 60-kg person).
INCHEM_WHO_jecfa_jecmono_v1042je01 NOAEL =240 mg/kg bw/day Human; Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v1042je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-fifth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1042je01.pdf; row_hash=bd0ee5c056bfd5c4; raw_unit=mg/kg bw per day; context=2263), the NOAEL of 240 mg/kg bw per day in a 13-week gavage study in male and female rats (8) provides an adequate MOE (2400) relative to the SPET estimate of 6000 ug/day (or 100 ug/kg bw per day for a 60-kg person).
INCHEM_WHO_jecfa_jecmono_v86je01 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v86je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=201a88a768d999b4; raw_unit=mg/kg bw; context=Requests for revisions and additions reported to the JECFA Secretariat Substance Original text Revised text Additional information Saccharin An ADI of 0-5 mg/kg bw for saccharin and its Ca, K, Na salts was established at 41st JECFA.
INCHEM_WHO_jecfa_jecmono_v86je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=201a88a768d999b4; raw_unit=mg/kg bw; context=Requests for revisions and additions reported to the JECFA Secretariat Substance Original text Revised text Additional information Saccharin An ADI of 0-5 mg/kg bw for saccharin and its Ca, K, Na salts was established at 41st JECFA.
INCHEM_WHO_jecfa_jecmono_v86je01 LOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=9e238b1acf355b81; raw_unit=mg/kg bw per day; context=In agreement with the study author, the Committee identified a lowest- observed-adverse-effect level (LOAEL) of 300 mg/kg bw per day based on the adverse effect on the central nervous system, including twitching and convulsions observed at all dose levels.
INCHEM_WHO_jecfa_jecmono_v86je01 LOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=9e238b1acf355b81; raw_unit=mg/kg bw per day; context=In agreement with the study author, the Committee identified a lowest- observed-adverse-effect level (LOAEL) of 300 mg/kg bw per day based on the adverse effect on the central nervous system, including twitching and convulsions observed at all dose levels.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =240 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=65419b5c69022731; raw_unit=mg/kg bw per day; context=The NOAEL of 240 mg/kg bw per day for trans-4-tert-butylcyclohexanol in a 13-week study in rats (9) is 2400 times the estimated dietary exposure of No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =226 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=2bc9393f763787be; raw_unit=mg/kg bw per day; context=Based on clinical signs of toxicity (piloerection and/or hunched posture) and reduced body weight and feed intake at the highest dose, the Committee identified a NOAEL of 2000 mg/kg feed for parental toxicity, equal to 151 and 226 mg/kg bw per day in males and females, respectively, in agreement with the study author.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =1500 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=3dd2ceccc7f5ba3a; raw_unit=mg/kg; context=The author of the study identified a NOAEL for dietary exposure of 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one for rats to be 1500 mg/kg in the diet for males, equivalent to 100 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =150 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=90e72329e3012a6f; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 150 mg/kg bw per day for parental toxicity, based on the effects observed in high-dose females. (v) Structurally related substances 4-tert-Butylcyclohexyl acetate (batch no.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =1000 mg/kg bw/day - oral 28-day Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=0a6cedcdf9de7f64; raw_unit=mg/kg bw per day; context=Based on these considerations, a NOAEL of 1000 mg/kg bw per day, the highest intake level tested, was identified for both sexes from the 28-day dietary toxicity study (22). (c) Genotoxicity studies Studies of in vitro genotoxicity reported for alicyclic ketones, secondary alcohols and related esters are summarized in Tabl
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =600 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=c646ce550ce2fe85; raw_unit=mg/kg bw per day; context=ied the NOAEL for maternal toxicity to be 150 mg/ kg bw per day because of the clinical signs of toxicity and reductions in body weight gain for the middle and high doses, and the NOAEL for developmental toxicity to be 600 mg/kg bw per day, the highest dose tested, because of the absence of any adverse effects attributable to the test item in the offspring (66). (ii) 2-sec-Butylcyclohexanone (No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =300 mg/kg bw/day - oral - Developmental toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=172e5f12e46a52cc; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was identified to be 5000 mg/kg feed, equivalent to a target dose of 300 mg/kg bw per day maternal exposure, because of fetal loss, pup mortality and reduced pup weights at the high dose consistent with the severity of maternal toxicity (17). (iv) 3,3,5-Trimethylcyclohexyl acetate (No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =500 mg/kg bw/day - - - Reproductive toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=b2194162b61d7eb1; raw_unit=mg/kg bw per day; context=The author of the study identified the NOAEL to be the highest dose tested of 500 mg/kg bw per day for male reproductive toxicity and the middle dose of 150 mg/kg bw per day for female reproductive toxicity.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =240 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=65419b5c69022731; raw_unit=mg/kg bw per day; context=The NOAEL of 240 mg/kg bw per day for trans-4-tert-butylcyclohexanol in a 13-week study in rats (9) is 2400 times the estimated dietary exposure of No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =226 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=2bc9393f763787be; raw_unit=mg/kg bw per day; context=Based on clinical signs of toxicity (piloerection and/or hunched posture) and reduced body weight and feed intake at the highest dose, the Committee identified a NOAEL of 2000 mg/kg feed for parental toxicity, equal to 151 and 226 mg/kg bw per day in males and females, respectively, in agreement with the study author.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =1500 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=3dd2ceccc7f5ba3a; raw_unit=mg/kg; context=The author of the study identified a NOAEL for dietary exposure of 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one for rats to be 1500 mg/kg in the diet for males, equivalent to 100 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =150 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=90e72329e3012a6f; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 150 mg/kg bw per day for parental toxicity, based on the effects observed in high-dose females. (v) Structurally related substances 4-tert-Butylcyclohexyl acetate (batch no.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =1000 mg/kg bw/day - oral 28-day Toxicology study document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=0a6cedcdf9de7f64; raw_unit=mg/kg bw per day; context=Based on these considerations, a NOAEL of 1000 mg/kg bw per day, the highest intake level tested, was identified for both sexes from the 28-day dietary toxicity study (22). (c) Genotoxicity studies Studies of in vitro genotoxicity reported for alicyclic ketones, secondary alcohols and related esters are summarized in Tabl
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =600 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=c646ce550ce2fe85; raw_unit=mg/kg bw per day; context=ied the NOAEL for maternal toxicity to be 150 mg/ kg bw per day because of the clinical signs of toxicity and reductions in body weight gain for the middle and high doses, and the NOAEL for developmental toxicity to be 600 mg/kg bw per day, the highest dose tested, because of the absence of any adverse effects attributable to the test item in the offspring (66). (ii) 2-sec-Butylcyclohexanone (No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =300 mg/kg bw/day - oral - Developmental toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=172e5f12e46a52cc; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was identified to be 5000 mg/kg feed, equivalent to a target dose of 300 mg/kg bw per day maternal exposure, because of fetal loss, pup mortality and reduced pup weights at the high dose consistent with the severity of maternal toxicity (17). (iv) 3,3,5-Trimethylcyclohexyl acetate (No.
INCHEM_WHO_jecfa_jecmono_v86je01 NOAEL =500 mg/kg bw/day - - - Reproductive toxicity document_id=jecfa_jecmono_v86je01; title=WHO FOOD ADDITIVES SERIES: 86 Prepared by the ninety-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v86je01.pdf; row_hash=b2194162b61d7eb1; raw_unit=mg/kg bw per day; context=The author of the study identified the NOAEL to be the highest dose tested of 500 mg/kg bw per day for male reproductive toxicity and the middle dose of 150 mg/kg bw per day for female reproductive toxicity.
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LEL >20 mL/kg bw Rat oral - acute QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14529/7/3/2?documentUUID=8c3ff7ae-99d8-44d7-853c-3d2a69067244; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15812934:F:--; 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_1b77958128e671c6231acfefb19b72d2
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd6c6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/31637/7/6/2?documentUUID=6aabdef5-8346-413e-8f35-bdf70fa320df; YEAR=2019; ORIGINAL_YEAR=2019; STUDY_GROUP=ECHA IUCLID:15830612:M/F:--; 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_5e939321a5c91e2169ecc96118d6fc78
ToxValDB_ECHA_IUCLID NOAEL >=1100 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd6b0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14529/7/6/2?documentUUID=8c3ff7ae-99d8-44d7-853c-3d2a69067244; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15844121:M/F:--; 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_e2c59cae8f8367925c05cd0a8f695761
openFDA substances 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier I909J9CFAT UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"I909J9CFAT"}
openFDA substances FDA UNII substance identifier YOJ58O116E UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"YOJ58O116E"}
openFDA substances FDA UNII substance identifier I909J9CFAT UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"I909J9CFAT"}
openFDA substances FDA UNII substance identifier I909J9CFAT UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"I909J9CFAT"}
openFDA substances FDA UNII substance identifier I909J9CFAT UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"I909J9CFAT"}
openFDA substances FDA UNII substance identifier YOJ58O116E UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"YOJ58O116E"}
openFDA substances FDA UNII substance identifier YOJ58O116E UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"YOJ58O116E"}
openFDA substances FDA UNII substance identifier YOJ58O116E UNII - - - protein {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"protein","unii_code":"YOJ58O116E"}