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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 249-793-7 | CAS number: 29710-25-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Cetyl esters is a constituent of a broader group of cosmetic ingredients, the alkyl esters, which consist ofthe reaction products of fatty acids and alcohols. The 237 alkyl esters being reviewed in a safety assessment by The Cosmetic Ingredient Review (CIR) Expert Panel (Panel).
The ingredients in this review are alkyl esters. The substance of interest (2-ethylhexyl 12-hydroxyoctadecanoate) is a member of the category group.
The members have the same functions, similar metabolic pathways and similar hazardous profile.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
Data considered in the CIR safety assessment of the group of substances were judged as reliabile and adequate for the purpose of the REACH registration and to fill the gap information.
(i) A clear substance characterisation is available: in the category definition (Fiume MM. et al., 2015) a description of the category members is available in the category members are listed in a table. A general chemical structure of the members is also provided. That means the chemical identity of chemicals is sufficiently clear for a meaningful assessment of the proposed read-across. where necessary, the degree of purity is reported.
(ii) description of the substances: a clear and unambiguous description of each member of the category is submitted (Name, CAS and/or EC number and chemical structure for the source substance and for the target)
(iii) similarity (characteristics in common between substances): the members of the category are alkyl esters. The core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by extended alkyl chains.
structural differences: some of these alkyl chains are saturated and some are unsaturated, and some of the chains are straight and some branched.
(iv) The study that was reported for is considered as adequate and reliable for the purpose of the
prediction based on read-across: the study results are adequate for the purpose of classification and labelling and risk assessment.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Alkyl Esters as Used in Cosmetics
- Author:
- Fiume MM. et al.
- Year:
- 2 015
- Bibliographic source:
- Int J Toxicol. 2015; 34(2 Suppl): 5S-69S.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
The test substance is applied to the skin to experimental animals. Subsequently, observations of effects (irritation and toxicity) and deaths are made
- Short description of test conditions: not specified
- Parameters analysed / observed: mortality - GLP compliance:
- not specified
- Remarks:
- This experimental study was reviewed in The Cosmetic lngredient Review Expert Panel (Panel) which assess the safety of 237 alkyl esters for use in cosmetics. The year is referred to the publication of the assessment.
- Test type:
- other: no data
Test material
- Reference substance name:
- Butyl myristate
- EC Number:
- 203-759-8
- EC Name:
- Butyl myristate
- Cas Number:
- 110-36-1
- Molecular formula:
- C18H36O2
- IUPAC Name:
- butyl myristate
- Test material form:
- not specified
- Details on test material:
- - State of aggregation:
not specified
- Particle size distribution: not relevant
- Mass median aerodynamic diameter (MMAD): not relevant
- Geometric standard deviation (GSD): not relevant
- Shape of particles: not relevant
- Surface area of particles: not relevant
- Crystal structure: not relevant
- Coating: not relevant
- Surface properties: not specified
- Density:
not specified
- Moisture content:
not specified
- Residual solvent:
not specified
- Activation:
not specified
- Stabilisation:
not specified
- Other:
not specified
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
no data
- Expiration date of the lot/batch:
no data
- Purity test date:
no data
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
not applicable
- Specific activity:
not applicable
- Locations of the label:
not applicable
- Expiration date of radiochemical substance:
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
no data
- Stability under test conditions:
no data
- Solubility and stability of the test substance in the solvent/vehicle:
no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
no data
- Preliminary purification step (if any):
no data
- Final dilution of a dissolved solid, stock liquid or gel:
no data
- Final preparation of a solid:
-
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: no data
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable
OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
no data
- other information: The Cosmetic lngredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: [yes/no] no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: To: no data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: not specified
- % coverage: not specified
- Type of wrap if used: not specified
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: not specified
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): not specified
- Constant volume or concentration used: yes/no not specified
- For solids, paste formed: yes/no not specified
VEHICLE
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): not specified
- Lot/batch no. (if required): not specified
- Purity: not specified - Duration of exposure:
- single application
- Doses:
- 2 mg/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes/no not specified
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- no data
Results and discussion
- Preliminary study:
- no data
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 other: g/kg
- Based on:
- not specified
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single application of 2 g/kg was nontoxic and nonirritating in rabbits
- Executive summary:
A single application of 2 g/kg was nontoxic and nonirritating in rabbits
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.