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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
The results of three studies of skin irritation in vivo performed on tetradecanoic acid were considered to determine the skin irritation potential of the test item. Since the test item is a reaction mass of tetradecanoic anhydride and tetradecanoic acid, tetradecanoic acid was used for the read-across.
The classification of the test item regarding the skin irritation is based on the study with the strictest result, which classifies tetradecanoic acid as "highly irritating". Here the total irritation score for all subjects for all 21 applications of the formulation containing 5% of myristic acid was 609 of a maximal possible score of 756. The substance was therefore classified as Category 2 (irritant) based on GHS criteria.
The classification of the test item regarding the eye irritation is based on an in-vivo study performed on tetradecanoic acid, where lotion formulations containing 1.5% of myristic acid resulted minimally irritating to rinsed and unrinsed treated eyes of rabbits. The test item was classified as Category 2 (irritating to eyes) based on GHS criteria.
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:
- June 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
- Remarks:
- information not available
- Specific details on test material used for the study:
- Commercial grade myristic acid
- Species:
- other: human
- Type of coverage:
- occlusive
- Number of animals:
- 20
- Details on study design:
- SIOPT (single insult occlusive patch test)
- Irritation parameter:
- other: primary irritation index
- Score:
- 0.2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Commercial grade myristic acid produced no irritation in 17, mild erythema in 2, and moderate erythema in 1 of 20 panelists.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation index was 0.2, and myristic acid was considered "practically non irritating."
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 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
- Remarks:
- information not available
- Specific details on test material used for the study:
- Several bar soap formulations with concentrations of Myristic Acid of 10, 22.1, and 91%
- Species:
- other: human
- Type of coverage:
- occlusive
- Amount / concentration applied:
- 0.2 mL volume of an 8% aqueous preparation
- Duration of treatment / exposure:
- once daily for 5 days
- Observation period:
- 5 days
- Number of animals:
- 16
- Details on study design:
- Preparation was applied to the ventral skin of the forearm under occlusive patches using the Frosch-Kligman soap chamber test
- Irritation parameter:
- erythema score
- Remarks:
- formulation with 10% myristic acid
- Score:
- > 0 - < 5
- Max. score:
- 1.41
- Remarks on result:
- positive indication of irritation
- Remarks:
- slightly irritating
- Irritation parameter:
- erythema score
- Remarks:
- formulation with 22.1 % myristic acid
- Score:
- > 0 - < 5
- Max. score:
- 1.73
- Remarks on result:
- positive indication of irritation
- Remarks:
- moderately irritating
- Irritation parameter:
- erythema score
- Remarks:
- formulation with 91% myristic acid
- Score:
- > 0 - < 5
- Max. score:
- 1.95
- Remarks on result:
- positive indication of irritation
- Remarks:
- moderately irritating
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The formulations were considered "slightly" to "moderately irritating" and erythema scores were 1.41, 1.73, and 1.95 on a scale of 0 to 5 for the formulations containing 10, 22.1, and 91% myristic acid, respectively.
- 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
- Remarks:
- information not available
- Specific details on test material used for the study:
- white cleanser lotion formulation containing 5% myristic acid
- Species:
- other: human
- Type of coverage:
- other: closed-patch
- Amount / concentration applied:
- formulation containing 5% myristic acid
- Duration of treatment / exposure:
- 21 days
- Number of animals:
- 12
- Irritation parameter:
- overall irritation score
- Basis:
- other: all subjects
- Score:
- 609
- Max. score:
- 756
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The total irritation score for all subjects for all 21 applications of the formulation was 609 of a maximal possible score of 756. The formulation was considered "highly irritating".
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 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
- Remarks:
- information not available
- Specific details on test material used for the study:
- Commercial grade myristic acid and 50% myristic acid in petrolatum.
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Albino rabbits
- Vehicle:
- not specified
- Amount / concentration applied:
- commercial grade myristic acid and 50% myristic acid in petrolatum
- Duration of treatment / exposure:
- 1 day
- Observation period (in vivo):
- 1 day
- Details on study design:
- Lotion formulations containing 1.5% myristic acid were applied to rinsed (20 mL ionized water at room temperature, 30 seconds after instillation) and unrinsed treated eyes of rabbits.
- Irritation parameter:
- other: not specified
- Basis:
- other: not specified
- Time point:
- 24 h
- Remarks on result:
- probability of mild irritation
- Remarks:
- Formulations were minimally irritating to rinsed and unrinsed treated eyes of rabbits
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Lotion formulations containing 1.5% myristic acid were minimally irritating to rinsed (20 mL ionized water at room temperature, 30 seconds after instillation) and unrinsed treated eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
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.