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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- not specified
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- 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
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isononanoic acid, C16-18-alkyl esters
- EC Number:
- 601-141-6
- Cas Number:
- 111937-03-2
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Isononanoic acid, C16-18-alkyl esters
- Test material form:
- not specified
- Details on test material:
- - State of aggregation:
not specified
- Particle size distribution:
not specified
- Mass median aerodynamic diameter (MMAD):
not specified
- Geometric standard deviation (GSD):
not specified
- Shape of particles:
not specified
- Surface area of particles:
not specified
- Crystal structure:
not specified
- Coating:
not specified
- 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:
- mouse
- Strain:
- not specified
- Details on species / strain selection:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
DETAILS OF FOOD AND WATER QUALITY: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To: not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on route of administration:
- feeding study
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 other: g/kg
- Dose / conc.:
- 300 other: g/kg
- Dose / conc.:
- 1 000 other: g/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- not specified
- Sacrifice and pathology:
- not specified
- Other examinations:
- not specified
- Statistics:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- The oral LD50 in mice was >5 g/kg
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- reversible fatty alterations were induced in the liver of female mid dose and male and female high-dose animals
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- no test article-related toxicity was observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 other: mg/kg bw *day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: fatty acid alterations
- Remarks on result:
- other: reversible fatty alterations were induced in the liver of female mid dose and male and female high-dose animals
- Remarks:
- reversible fatty alterations were induced in the liver of female mid dose and male and female high-dose animals
- Dose descriptor:
- other: LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- mortality
Applicant's summary and conclusion
- Conclusions:
- The oral LD50 in mice was >5 g/kg; in an oral study in which rats were dosed with 100, 300, or 1000 mg/kg, reversible fatty alterations were induced in the liver of female mid dose and male and female high-dose animals and the NOAEL was 100 mg/kg/d.
- Executive summary:
The oral LD50 in mice was >5 g/kg; in an oral study in which rats were dosed with 100, 300, or 1000 mg/kg, reversible fatty alterations were induced in the liver of female mid dose and male and female high-dose animals and the NOAEL was 100 mg/kg/d.
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.
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