Eleven evidence items: three verified on the target itself, one explicit read-across, three identifier-only, four unresolved

Asked:

“ATLAS Batch 08 / rotation 01 / 4 September 2026. Independent GAP-ONLY verification, not a repeat of all 33 axes… Use exact primary authority documents/records and original studies… Absence from lists is not safety clearance; PBT exemption is not environmental non-applicability. Unknown evidence is not proof of harm… ASSIGNED: DIISOSTEARYL MALATE”

A bounded gap-only verification of diisostearyl malate (UNII QBS8A3XZGQ) across five primary sources: the FDA UNII service, GSRS/NCATS, the CIR 2012 dialkyl-malates PDF, one 1987 PubMed abstract, and identifier cross-codes to ECHA and EPA CompTox. Each item below is labelled by evidence status, not risk.

Evidence-status matrix

Verified corrections

Identity. FDA (issuer) maps the name to UNII QBS8A3XZGQ; the GSRS/NCATS record (host/registry, record version 8) is racemic and distinguishes CAS 81230-05-9 as primary from 67763-18-2 as major component structure — the two CAS numbers are not demonstrated equivalent commercial stereochemical grades. precision.fda.gov · gsrs.ncats.nih.gov

Hayakawa 1987 is not proven neat-material sensitization. The abstract (the only accessible text) reports one 18-year-old with cheilitis; ingredient tests positive to glyceryl diisostearate and diisostearyl malate; GC found one impurity; impurities were “suspected” as cause. The 0.25% pet figure is isostearyl alcohol in diisostearyl malate, not the target's patch concentration, which remains unresolved without full text. ncbi.nlm.nih.gov

Cross-codes are identifiers, not findings. GSRS cross-codes ECHA EC 267-041-6 / entity 100.060.928 and EPA CompTox DTXSID30867325; neither dashboard yielded readable endpoint content here, so no hazard result attaches to either code. comptox.epa.gov

Newly supported scoped findings

Direct target — HRIPT. CIR final-report PDF (host timestamp 27 September 2012): diisostearyl malate 100%, 0.2 mL/0.2 g, n=51 human volunteers, dermal; no adverse effects during induction or challenge (Irritation and sensitization → Sensitization → Dermal–Human, ref 54). Full schedule, enrollment/completion split and inclusion criteria were not recovered. This normal-volunteer HRIPT and the single impurity-suspected case are not automatically conflicting. cir-safety.org

Direct target — Ames. Same PDF: Salmonella typhimurium TA98, TA100, TA1535, TA1537 at 312.5, 625, 1250, 2500 and 5000 µg/plate, with and without metabolic activation; not mutagenic (Genotoxicity, ref 41; extracted page locator 4). This is not cancer clearance. cir-safety.org

Explicit read-across. The CIR Panel grouped dialkyl malates on similar structures, physicochemical properties, cosmetic functions and use concentrations, noting possible skin esterase hydrolysis of the diester to monoester and possibly malic acid plus isostearyl alcohol, and used malic-acid and corresponding-alcohol data to conclude the listed dialkyl malates safe only in present practices of use and concentration. This is expert read-across, not direct diisostearyl-malate DART evidence. cir-safety.org

Genuine remaining gaps

• ECHA: the entity URL opened with no endpoint text and the legacy dossier URL failed, so no fate, biodegradation, bioaccumulation, aquatic-toxicity, PBT, endocrine or direct DART result was verified. A registrant dossier is not an ECHA agency conclusion; PBT exemption would not imply environmental non-applicability.

• EPA CompTox: identifier mapping verified; endpoint content unreadable here — not endocrine evidence either way.

• Current law: no exact current consolidated EU Regulation 1223/2009 Annex II–VI hit/no-hit record and no exact current ASEAN/HSA annex search were obtained for the verified identity. Both stay unresolved; absence is not clearance.

• Read-across donors: exact donor-specific DART study identities, stereochemistry, routes, doses, populations and stated bridges were not recovered.

• Hayakawa full text: the target's exact patch-test concentration and protocol remain unresolved.

Source ledger

Item	Status	Qualified conclusion / limitation	Source

Gap-only verification, 11 evidence items assembled from 5 primary result sets (CIR extracted study rows, official FDA identity record, CIR HRIPT/read-across evidence, original PubMed abstract, identity cross-code context); CIR PDF host timestamp 27 September 2012; low-quality third-party pages excluded. Status labels describe evidence provenance, not risk. Absent records are not clearance; unknown evidence is not harm. Bounded review, ≤1,800 words; no database access or paywall bypass.

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