NOAEL Studies Cosmetic Ingredient

6-Hydroxyindole NOAEL Studies

INCI: 6-HYDROXYINDOLE

CAS: 2380-86-1 (per CIR/SCCP records)

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 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =100 - rat oral gavage 13 weeks NOAEL study 25, p.4
CIR Safety Assessment NOAEL =150 - rat oral gavage gestation days 6-15 NOAEL study 26, p.4
CIR Safety Assessment NOAEL =240 - rat oral gavage gestation days 6-19 NOAEL study 27, p.5
CIR Safety Assessment NOAEL =25 - rat oral gavage 105 weeks NOAEL study 36, p.6
SCCNFP Opinion 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP Opinion NOAEL =100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity Ref. : 5 2, p.7
SCCNFP Opinion NOAEL =30 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity Ref. : 5 2, p.7
SCCNFP Opinion NOAEL =50 mg/kg bw/day human - - dermal absorption Ref. : 14 2, p.11
SCCNFP Opinion NOAEL =0 mg/kg bw/day rat oral 13-week carcinogenicity p.19
ECHA 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LEL ~600 mg/kg bw/day Rat oral - acute 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/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15811557: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_4b8e26b0a29f0f1a2d8a1a15a6e39754
ECHA NOAEL ~100 mg/kg bw/day Rat oral - chronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bcb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817912_15817913: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_aca6205bac2e427f48cac0e61eccd5ca
ECHA NOAEL ~25 mg/kg bw/day Rat oral - chronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bcb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=body weight and weight gain|haematology; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|hematology; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817912_15817913: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_73dc21991983eaa5c9a1a161da7446de
ECHA NOAEL ~150 mg/kg bw/day Rat oral - reproduction developmental STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcece; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=maternal: food consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption; STUDY_GROUP=ECHA IUCLID:15823114:F:-maternal; 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_5c59440df51e78770a1c760528b77362
ECHA NOAEL ~30 mg/kg bw/day Rat oral - short-term STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cae7e4b0a7c65d2240a2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15845381: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_212973cfca135b57d41b7c649cb0ff18
ECHA NOEL ~50 mg/kg bw/day Rat oral - developmental STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcece; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=fetus: skeletal malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821834:-:-fetal; 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_effa3d2dec69e2fc73b87990d75524f5
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 100 - rat oral gavage 13 weeks - p.4
Regulatory source - 150 - rat oral gavage gestation days 6-15 - p.4
Regulatory source - 240 - rat oral gavage gestation days 6-19 - p.5
Regulatory source - 25 - rat oral gavage 105 weeks - p.6
Regulatory source carcinogenicity 0 mg/kg bw/day rat oral 13-week carcinogenicity p.19
Regulatory source dermal absorption 50 mg/kg bw/day human - - dermal absorption p.11
Regulatory source genotoxicity 50 mg/kg bw/day rat oral 13-week genotoxicity p.19
Regulatory source repeated dose toxicity 100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity p.7
Regulatory source repeated dose toxicity 30 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity p.7