Bounded closeout finds usable exact evidence for only 5 of 25 SKIN1004 materials — the rest stay evidence-insufficient

Asked (summary):

Project ATLAS / ASTRA — SKIN1004 scientific closeout, 15 September 2026. Perform a bounded, gap-only scientific review of 25 exact current materials and 255 unresolved axes, preserving exact material boundaries and already-resolved axes; return scoped statuses, applicability conditions, exact missing prerequisites, and fully documented findings from primary authorities or original studies.

The bounded search on 15 September 2026 retrieved 598 candidate records — 12 tightly filtered authority provisions, 180 original-study and government-toxicology rows, and 406 botanical identity and study leads — spanning CIR and PubMed/NCBI hosts. Most rows are near-neighbor analogues or efficacy leads, not exact-material findings; individual CIR conclusions here may be single-sourced. This is a scientific gap review, not a blanket product-safety judgment.

Evidence coverage across the closeout, by material family

Each bar is the retrieved record count per material family (square-root axis). Colour is boundary status, not volume: only green families yielded exact usable records. Hover or tap a bar for the actual retrieved material names behind it.

exact usable record retrieved scoped or adjacent only — status unresolved analogue / efficacy leads only — not transferable

Exact usable records

The small subset where retrieved evidence matches the requested material tightly enough to state a scoped status.

Butyrospermum parkii (shea) butter

CIR — tentative 2016 report, single-sourced

9 butter, oil and glyceride ingredients concluded safe as used in present practices of use and concentration; 4 nut and seedcake ingredients insufficient to determine safety. Shea oil is US GRAS as a direct food additive (21CFR§184.1702). cir-safety.org

Acrylates copolymers (grouped)

Original patch-test study, 1302 patients

No reactions to acrylates/C10-30 alkyl acrylate cross-polymer (Carbopol) 2% aq.; sodium polyacrylate 2% aq. gave one positive of unknown relevance. Grade and residual-monomer identity for the requested polymer remain open. pubmed.ncbi.nlm.nih.gov

Phytosterols

CIR — tentative status in retrieved copy, single-sourced

Panel concluded phytosterols safe as cosmetic ingredients in the practices of use and concentration of the assessment; the retrieved copy is the 2013 tentative report for public comment. cir-safety.org

Lauric acid

CIR table — prior safe conclusion, single-sourced

A CIR table records lauric acid (CAS 143-07-7) as previously reviewed "Safe" (JACT 1987; re-reviewed, not reopened, 2006). Finished-product concentration in the requested formula is unknown. cir-safety.org

Tea tree (Melaleuca alternifolia) oil

Original randomized trial, 158 patients

25% and 50% topical solutions over 4 weeks: dermatitis in 1 patient at 25% and 3 at 50% (one withdrawn). Concentrations exceed leave-on cosmetic use; oxidation state and chemotype unreported. pubmed.ncbi.nlm.nih.gov

Hydrolyzed sodium hyaluronate

Adjacent only — status unresolved

The 2023 CIR hyaluronates sheet notes 7 hyaluronate names are not restricted under EU cosmetic rules — non-restriction, not clearance. Molecular weight and CAS of the hydrolyzed grade stay ambiguous. Single-sourced. cir-safety.org

Boundary risks that block transfer of nearby evidence

Why most of the 255 requested axes stay evidence-insufficient even where records exist.

Unknown finished-product concentration. CIR "safe as used" conclusions and trial doses (25–50% tea tree oil, 2% aq. Carbopol patch tests) cannot be mapped onto SKIN1004 formulas whose concentrations and exposures were unavailable.
Botanical taxon, part and preparation. The 406 botanical leads are dominated by Ocimum (111), neem (99) and Curcuma longa (96) efficacy or mismatched-preparation records — extracts, oils and homeopathic products that do not match the requested taxon/part/preparation and are not findings.
Polymer grade and residual monomers. Grouped acrylates evidence covers named test articles; the requested copolymer's UVCB grade and residual-monomer profile are undocumented.
Tea-tree-oil oxidation and chemotype. Sensitization risk tracks oxidation products and chemotype, neither reported in the retrieved trials.
Hydrolyzed sodium hyaluronate molecular weight / CAS. EU non-restriction of the hyaluronate group does not resolve the hydrolyzed grade's identity; salt/hydrate and oil-versus-water form mismatches likewise block dextrin sulfate, salicylic-acid and curcumin near neighbors from standing in for requested materials.

What the retrieved rows add

Grouped acrylates patch testing of 1302 patients found no reactions to Carbopol-type acrylates/C10-30 alkyl acrylate cross-polymer at 2% aqueous — grade and residual-monomer identity still ungoverned — pubmed.ncbi.nlm.nih.gov
The 158-person randomized tea-tree-oil trial recorded dermatitis in 1 of the 25% group and 3 of the 50% group over 4 weeks — at concentrations far above leave-on cosmetic use, with oxidation state and chemotype unreported — pubmed.ncbi.nlm.nih.gov
The retrieved shea assessment is the tentative 2016 CIR report: 9 butter, oil and glyceride ingredients safe as used, 4 nut and seedcake ingredients insufficient — single-sourced — cir-safety.org
The 2023 CIR hyaluronates sheet notes EU non-restriction across 7 hyaluronate names, but non-restriction is not clearance and the hydrolyzed grade's molecular weight and CAS remain ambiguous — single-sourced — cir-safety.org

Authority provisions and exact-family study rows

All 12 authority rows plus the 63 study rows in exact or tightly scoped families; the 406 botanical leads and remaining analogue rows are summarized in the chart above.

TypeRetrieved materialProvision / resultScope / endpointSource

Method: bounded gap-only review for the SKIN1004 25-material closeout, search date 2026-09-15. 598 retrieved rows — 12 filtered authority/regulatory provisions, 180 original-study/government-toxicology candidates, 406 botanical identity/assessment/study leads — from CIR and PubMed/NCBI hosts. Bars count retrieved records per material family, not evidence quality; colour marks boundary status. Individual CIR conclusions may be single-sourced. Analogue and efficacy rows are shown as coverage only and were cut from the table for space; non-listing, food-use status and near-neighbor evidence are not clearance for a requested different material.

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