NOAEL Studies Cosmetic Ingredient

HC Orange No. 1 NOAEL Studies

INCI: HC ORANGE NO. 1

CAS: 54381-08-7

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 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment DERMAL_ABSORPTION =1.28 % human (cadaver skin, in vitro) dermal - Static horizontal diffusion cells using human female cadaver split-thickness skin; 14C-HC Orange No. 1 (specific activity: 38.1 pc/mg) mixed with nonradioactive HC Orange No. 1 in hair dye base at 1.0% concentration (0.130 µCi/mg); applied at 10 mg/cm² for 30 min then rinsed; receptor fluid sampled at 1, 2, 4, 6, 8, 24, 30, and 48 hours p.4
COSMOS DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 2.5 mg/kg bw/day rat oral 91 day Subchronic SCCP; Henwood S. M. 91-Day Oral Gavage Toxicity Study With GTS03977 In Rats With A 4-Week Recovery Period, P&G Study #2749-53922, September 2005
SCCS Opinion 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =750 mg/kg/day rat oral Sub-chronic repeated dose toxicity p.15
SCCS Opinion NOAEL =300 mg/kg/day rat oral Sub-chronic repeated dose toxicity p.15
SCCS Opinion NOAEL =25 mg/kg bw/d - - Chronic carcinogenicity p.16
SCCS Opinion NOAEL =75 mg/kg/day - oral developmental developmental toxicity p.26
SCCS Opinion NOAEL =250 mg/kg/day - oral developmental developmental toxicity p.26
SCCS Opinion NOAEL =0.15 % rat dermal 13 week developmental toxicity p.27
SCCS Opinion NOAEL =0.024 mg/kg bw rat oral 90-day dermal absorption p.28
SCCS Opinion NOAEL =25 mg/kg bw rat oral 90-day dermal absorption p.28
SCCS Opinion NOAEL =75 mg/kg bw/day guinea pig - developmental reproductive toxicity p.28
Regulatory source 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source carcinogenicity 25 mg/kg bw/d - - Chronic carcinogenicity p.16
Regulatory source dermal absorption =0.024 mg/kg bw rat oral 90-day dermal absorption p.28
Regulatory source dermal absorption =25 mg/kg bw rat oral 90-day dermal absorption p.28
Regulatory source developmental toxicity 75 mg/kg/day - oral developmental developmental toxicity p.26
Regulatory source developmental toxicity 250 mg/kg/day - oral developmental developmental toxicity p.26
Regulatory source developmental toxicity 0.15 % rat dermal 13 week developmental toxicity p.27
Regulatory source repeated dose toxicity 750 mg/kg/day rat oral Sub-chronic repeated dose toxicity p.15
Regulatory source repeated dose toxicity 300 mg/kg/day rat oral Sub-chronic repeated dose toxicity p.15
Regulatory source reproductive toxicity 25 mg/kg bw/d guinea pig - developmental reproductive toxicity p.28
Regulatory source reproductive toxicity 75 mg/kg bw/day guinea pig - developmental 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 Z92U49184U UNII - - - chemical -