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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Since alkyl anhydrides are usually skin corrosives and eye irritants due to the properties of the anhydridic group, the test item is considered to be classified as skin corrosive categorie 1 and eye irritant categorie 1 based on GHS criteria.
Hexadecanoic acid was found not classified as skin or eye corrosive based on GHS criteria resulting from available data.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Guideline:
- other: information not available
- Principles of method if other than guideline:
- Standard Schwartz-Peck procedure
- GLP compliance:
- not specified
- Remarks:
- information not available
- Species:
- other: human
- Type of coverage:
- other: closed and open patches
- Vehicle:
- not specified
- Amount / concentration applied:
- formulation of 2.2% palmitic acid
- Duration of treatment / exposure:
- Application to the skin 10-14 days apart in the standard Schwartz-Peck procedure
- Number of animals:
- 101 human subjects
- Details on study design:
- Two 24-hr closed and open patches are applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure
- Irritation parameter:
- other: information not available
- Remarks on result:
- no indication of irritation
- Remarks:
- 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Since the test item is a reaction mass of hexadecanoic anhydride and hexadecanoic acid, hexadecanoic acid was used for the read-across.
- Reason / purpose for cross-reference:
- read-across source
- Guideline:
- other: information not available
- Principles of method if other than guideline:
- Standard Schwartz-Peck procedure
- GLP compliance:
- not specified
- Remarks:
- information not available
- Species:
- other: human
- Type of coverage:
- other: closed and open patches
- Vehicle:
- not specified
- Amount / concentration applied:
- formulation of 2.2% palmitic acid
- Duration of treatment / exposure:
- Application to the skin 10-14 days apart in the standard Schwartz-Peck procedure
- Number of animals:
- 101 human subjects
- Details on study design:
- Two 24-hr closed and open patches are applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure
- Irritation parameter:
- other: information not available
- Remarks on result:
- no indication of irritation
- Remarks:
- 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Guideline:
- other: information not available
- GLP compliance:
- not specified
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- Albino rabbits
- Type of coverage:
- not specified
- Amount / concentration applied:
- Formulations of 2.2-74% palmitic acid
- Duration of treatment / exposure:
- 2-24 hr
- Irritation parameter:
- other: information not available
- Remarks on result:
- probability of weak irritation
- Remarks:
- Minimal erythema and no edema
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Administration of product formulations containing 2.2-74% palmitic acid produced minimal erythema and no edema 2-24 hr after application to the skin of albino rabbits
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Since the test item is a reaction mass of hexadecanoic anhydride and hexadecanoic acid, hexadecanoic acid was used for the read-across.
- Reason / purpose for cross-reference:
- read-across source
- Guideline:
- other: information not available
- GLP compliance:
- not specified
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- Albino rabbits
- Type of coverage:
- not specified
- Amount / concentration applied:
- Formulations of 2.2-74% palmitic acid
- Duration of treatment / exposure:
- 2-24 hr
- Irritation parameter:
- other: information not available
- Remarks on result:
- probability of weak irritation
- Remarks:
- Minimal erythema and no edema
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Administration of product formulations containing 2.2-74% palmitic acid produced minimal erythema and no edema 2-24 hr after application to the skin of albino rabbits
Referenceopen allclose all
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.