Formaldehyde (gas) can cause cancer according to an independent committee of scientific and health experts.
Definition
Formaldehyde (gas) can cause cancer according to an independent committee of scientific and health experts.
Source: PubChem
US FDA substance register · UNII 1HG84L3525 · registered name Formaldehyde · single chemical substance
Formaldehyde is the aldehyde that conforms to the formula:
Cosmetic roles
Safety & regulatory references
- Banned
- European Union · South Korea · Taiwan · United Kingdom
- Restricted or banned
- European Union · Japan · South Korea · Taiwan
Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · MFDS (Korea) cosmetic regulatory information · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)
ASEAN
- Field of application and/or use : Nail hardeners
- Maximum authorised concentration in the finished cosmetic product : 2.2% calculated as formaldehyde
- Other limitations and requirements : As a preservative, see Annex VI, Part1, No. 5. Allowed only in Lao PDR and Vietnam
- Conditions of use and warning which must be printed on the labels : Protect cuticles with grease or oil. Contains formaldehyde (2)
Canada
- Conditions of Use by product type : (a) Not permitted in aerosol products. (b) Non-aerosol products that release formaldehyde vapours when used according to directions. (c) Oral products (d) Non-oral products as a preservative (e) Nail hardeners, must be sold with nail shields and directions for use.
- Maximum Concentration Permitted : (b) 0.01% (c) 0.1% (d) 0.2% (e) 5.0%
- Warnings and Cautionary Statements: (to the effect of) : e) "This product contains formaldehyde which has the potential to cause skin sensitivity."
China
- Maximum concentration : 5%
Source: MFDS (Korea) cosmetic regulatory information
Korea’s toxic-substance GHS classification: Danger · H311 (category 3) · H314 (category 1) · H330 (category 2) · +6 more
EU Cosmetics Regulation, Annex II (prohibited substances), entry 1577
Restriction II/1577 · Other restriction: ban substances that deplete the ozone layer
Source: EU CosIng ingredient list
Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments - 2004/2005
Reviewed by CIR: Amended Safety Assessment of Formaldehyde and Methylene Glycol as Used in Cosmetics
Reviewed by CIR: Final Report on the Safety Assessment of Formaldehyde
More data — names, identifiers, properties, test records, literature
Names & identifiers
- CAS No.chemical registry number
- 50-00-0
- EC No.EU chemical inventory number
- 200-001-8
- DTXSIDUS EPA chemical ID
- DTXSID7020637
- DTXCIDUS EPA compound ID
- DTXCID30637
- IUPAC
- Formaldehyde
- Molecular formula
- CH2O
- Molecular weight
- 30.026 g/mol
Measured properties
- Colour
- colourless
- Odour threshold
- 0.5~1.0 ppm
- pH
- 2.8~4
- Melting/freezing point
- -92 ℃
- Initial boiling point and range
- -19~-21 ℃ (1013.25 hPa)
- Flash point
- 85 ℃(, 50℃)
- Upper/lower flammability or explosive limits
- 73 / 7 %
- Vapour pressure
- 1.3187 hPa(20℃)
- Water solubility
- 400 g/ℓ(20℃)
- Relative density
- 1.15
- n-Octanol/water partition coefficient (Kow)
- 0.35 (log Pow, 25℃)
- Auto-ignition temperature
- 430 ℃(1013.25 hPa)
- Viscosity
- 2.45 cP(25℃)
- Molecular weight
- 30.0258
Values measured on the substance itself. The KOSHA data are a reference for writing and reviewing safety data sheets, not a specification for a commercial raw material.
Source: KOSHA safety data sheets (Korea)
What products actually use it for
What the 134 products reported to the US EPA with this ingredient use it for. Products outside cosmetics are included, so the top few rows are its main uses.
- Degradant/impurity (EPA)28
- Monomers25
- No specific technical function14
- Preservative13
- Binder12
- Biocide8
- Processing aids not otherwise specified8
- Soil amendments5
15 other uses
- Adhesion/cohesion promoter5
- Intermediate2
- Sealant (barrier)2
- Embalming agent1
- Elasticizer1
- Chemical reaction regulator1
- Fixing agent (mordant)1
- Insulators1
- Deodorizer1
- Chelating agent1
- Plasticizer1
- Surfactant (surface active agent)1
- Energy releasers (explosives, motive propellant)1
- Propellants, non-motive (blowing agents)1
- Dispersing agent1
Source: US EPA CompTox dashboard
Irritation and sensitisation studies
15 skin studies and 4 eye studies are on record.
The studies disagree (the most common conclusion covers 50%), so they do not establish that this ingredient is irritating. These tests are on the raw material itself; irritation at the amount in a finished product is a different question.
See all 19 studies
- High Frequency of Sensitization
skin sensitisation: in vivo (non-LLNA) · Screening · equivalent or similar to OECD Guideline 406 (Skin Sensitisation) - Category 8.2C (Category 1C)
Skin Irritation · Read Across - Sh
Skin Sensitization · Authoritative - High Frequency of Sensitization
skin sensitisation: in vivo (LLNA) · Screening · equivalent or similar to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) - Category 6.5B (Category 1)
Skin Sensitization · Read Across - Skin Sens. 1
Skin Sensitization · Screening - High Frequency of Sensitization
skin sensitisation: in vivo (non-LLNA) · Screening · according to OECD Guideline 406 (Skin Sensitisation) - Ambiguous
skin sensitisation: in vivo (non-LLNA) · Screening · equivalent or similar to OECD Guideline 406 (Skin Sensitisation) - Category 6.3A (Category 2)
Skin Irritation · Read Across - Skin Sens. 1
Skin Sensitization · Authoritative - Skin Corr. 1B
Skin Irritation · Authoritative - Skin Corr. 1B
Skin Irritation · Screening - Corrosive
skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) equivalent or similar to - Skin sensitisation - category 1
Skin Sensitization · Screening - Skin corrosion - category 1
Skin Irritation · Screening - Category 8.3A (Category 1)
Eye Irritation · Read Across - Serious eye damage/eye irritation - Category 2
Eye Irritation · Screening - Category 6.4A (Category 2A)
Eye Irritation · Read Across - Eye Dam. 1
Eye Irritation · Screening
Source: US EPA CompTox dashboard
Related literature
- Occupational contact allergy to formaldehyde and formaldehyde releasers · 2008
- Contact allergy to formaldehyde · 2011
- Formaldehyde‐releasers: relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde‐releasers · 2009
- Mobile and hydrolysable formaldehyde in low-formaldehyde finishing of cellulose textiles · 2005
- A method for quantification of formaldehyde in the presence of formaldehyde donors in skin‐care products · 1998
Linked databases 28
- AICIS inventory notices (Australia)
- ASEAN Cosmetic Directive
- Australian Industrial Chemicals Inventory (AICIS)
- ChEBI
- ChEMBL
- China inventory of existing ingredients (IECIC)
- EU CosIng ingredient list 2
- EU Cosmetics Regulation
- EU prohibited substances (Annex II)
- Health Canada Cosmetic Ingredient Hotlist
- IARC carcinogen classification
- Korea toxic substances GHS register (NIER)
- KOSHA safety data sheets (Korea)
- MFDS (Korea) cosmetic regulatory information 2 3 4
- NIST Chemistry WebBook
- PubChem
- Taiwan FDA cosmetic ingredients
- Tlooto literature search 2 3 4 5
- UK cosmetics regulations (OPSS)
- UniChem cross-reference IDs
- US Cosmetic Ingredient Review (CIR) 2 3 4
- US EPA CompTox dashboard 2
- US EPA DSSTox chemical database
- US FDA substance registration (GSRS)
- US FDA Unique Ingredient Identifier (UNII)
- US National Toxicology Program reports
- Wikidata
- Wikipedia · Korean · English · Japanese · Chinese