Excellent Cosmetic Ingredient NOAEL Data

Silica

Also known as: Silicon dioxide, SiO2, Aerosil M-300, Aerosil bs-50, Aerosil-degussa, Amorphous silica dust (+15 more)

INCI: SILICA

Silica (CAS 7631-86-9) is a cosmetic cosmetic ingredient functioning as rheology modifier, thickener, anticaking agent, opacifier. NOAEL 16.6667 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 7631-86-9 →

Auto-generated CPSR Part A draft with source citations
Function
rheology modifier, thickener, anticaking agent, opacifier
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
231-545-4

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA-approved inorganic. Widely used. GRAS for food. No concentration restriction in cosmetics.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Silica.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Silica. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 800 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL =500 mg/kg - - NOAEL study SCCS_vision_codex
NOAEL =500 mg/kg/day oral rat reproductive toxicity SCCS_vision_codex
NOAEL =500 mg/kg - - NOAEL study SCCS_vision_codex
NOAEL =500 mg/kg/day oral rat reproductive toxicity SCCS_vision_codex
NOAEL =500 mg/kg - - NOAEL study SCCS_vision_codex
NOAEL =500 mg/kg/day oral rat reproductive toxicity SCCS_vision_codex
NOAEL =500 mg/kg - - NOAEL study SCCS_vision_codex
NOAEL =500 mg/kg/day oral rat reproductive toxicity SCCS_vision_codex

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Silica across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LD50 >2000 mg/kg Rat oral - ECHA IUCLID
NOAEL =1000 mg/kg-day Rat oral short-term ECHA IUCLID
NOEL =1000 mg/kg-day Rat oral - ECHA IUCLID
NOEL >1000 mg/kg-day Rat oral - ECHA IUCLID
NOEL =1000 mg/kg-day Rat oral - ECHA IUCLID
NOEL =1000 mg/kg-day Rat oral - ECHA IUCLID
LOAEL =15 mg/m3 Monkey inhalation chronic TX TCEQ
LOEL =50 mg/kg-day Mouse oral short-term ECOTOX
LOEL =500 mg/kg-day Mouse oral short-term ECOTOX
LOEL =665 mg/kg-day Mouse oral short-term ECOTOX

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
Sup 7, 68
Evaluation Year
1996

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1,000,000 - 10,000,000 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No

Additional Ingredient Properties

10 property records from structured ingredient metadata.

comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,combination,normal,acne-prone", "acne_safe": "yes", "source": "Absorbent powder"}
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "10.0", "typical_concentration_pct": "5.0", "product_type": "Primer", "function_at_concentration": "Mattifying, pore blurring", "source": "Supplier TDS"}
ecotoxicity
{"biodegradable": "no", "biodegradation_days": "non-biodegradable", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "very low toxicity", "freshwater_toxicity": "minimal impact", "soil_toxicity": "inert", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "possible nano", "hawaii_banned": "…
emulsifier
{"cas_number": "7631-86-9", "ingredient_class": "Pickering_emulsifier", "chemical_type": "mineral", "emulsion_type_primary": "O/W", "droplet_size_typical_um": "0.1-1", "lamellar_phase": "no", "hexagonal_phase": "no", "cubic_phase": "no", "gel_network_formation": "no", "viscoelastic_properties": "no", "rheology_modification": "yes", "viscosity_building": "yes", "pseudoplastic_behavior": "no", "thix…
polymer
{"cas_number": "7631-86-9", "ingredient_class": "opacifier/texture_modifier", "polymer_type": "other", "chemical_backbone": "other", "ionic_character": "nonionic", "pH_viscosity_sensitivity": "moderate", "salt_tolerance": "moderate", "electrolyte_effect_on_viscosity": "moderate", "temperature_viscosity_sensitivity": "moderate", "film_transparency": "transparent", "removability": "easy", "flyaway_r…
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
sensory
{"silky": "powdery", "smooth, glides easily": "velvety, absorbing", "dry-touch, non-greasy": "dry, matte", "instant": "instant", "low": "low", "w/o": "w/o", "very-high": "excellent", "no": "yes", "yes": "no", "light-diffusing": "blurring", "1.40": "1.46", "transparent": "opaque", "colorless": "white", "excellent": "excellent", "light": "light", "synthetic": "mineral"}
skin_suitability
{"oily_skin": "recommended", "dry_skin": "acceptable", "sensitive_skin": "acceptable", "combination_skin": "recommended", "normal_skin": "acceptable", "acne_prone": "recommended", "rosacea": "acceptable", "eczema": "acceptable", "hyperpigmentation": "acceptable", "aging_mature": "acceptable", "dehydrated": "acceptable", "skin_benefit_primary": "mattifying", "skin_benefit_secondary": "oil-absorbing…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Abrasive Absorbent Adhesion/cohesion promoter Adsorbent Anti-adhesive/cohesive Anti-caking agent Antioxidant Binder Catalyst Conductive agent
Regulatory List Membership (6)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS) Consumer Product Chemical

Expert Verdict

Expert safety assessment and concern-level summary for Silica.

Regulatory Flags

mineral-origin reach-spm-exempt inorganic cosmos-certified hydrophilic fumed-silica amorphous shear-thinning thixotropic temperature-independent thermal-stability color-cosmetics nano-label-required-if-nano aerosil-200 eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Silica by CAS number or substance name.

Studies
26
Lowest NOAEL
497
Highest NOAEL
9250

Units vary across source rows: mg/kg bw/day, mg/kg, mg/kg/day

ToxValDB_ECHA_IUCLID COSMOS_DB SCCS_vision_codex

Known Synonyms

Silicon dioxide, SiO2 Aerosil M-300 Aerosil bs-50 Aerosil-degussa Amorphous silica dust Cabosil N 5 Cabosil st-1 Cab-o-sil M-5 Caswell No. 734A EINECS 231-545-4 EPA Pesticide Chemical Code 072605 Hydrophobic silica 2482 Pigment White 27 Silica, amorphous fused Silica particles Silicon oxide Sipernat Wessalon UNII-ETJ7Z6XBU4 (SiO2)n

Chemical Function

Abrasive Viscosity modifier Filler

Regulatory Lists

Pesticides children; Europe; Personal care children; Europe; Personal care - dental care - toothpaste Cleaning products and household care; Europe Europe; Personal care - liniment consumer_product; Europe Europe; Personal care Europe; Personal care IFRA Transparency SCIL (9/2019) Journal of Chemical Engineering & Process Technology consumer_product Cleaning products and household care - laundry and fabric treatment - laundry detergent; Europe Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener inert_ingredient; Pesticides inert_ingredient; non_food_use; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
silicon dioxide
ChEMBL ID
CHEMBL2108563
Adverse Event Associations
464
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives + fda_gras_enriched

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Silicon dioxide
E Number
E551
FDA GRAS
At the notifier's request, FDA ceased to evaluate this notice
GRN
298
Food Category
preservative

Use in a variety of foods and food-packing materials

View full food safety profile →

Frequently Asked Questions

Is Silica safe in cosmetics?

Silica has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Silica allowed in the EU?

Silica EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Silica do in cosmetics?

Silica functions as: rheology modifier, thickener, anticaking agent, opacifier. It is classified as a cosmetic ingredient in our database. CAS number: 7631-86-9.

What is the NOAEL for Silica?

The NOAEL (No Observed Adverse Effect Level) for Silica is 500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Silica used outside cosmetics?

Silica also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Is Silica in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Silica in your formulation.