Registration Dossier
Registration Dossier
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EC number: 249-793-7 | CAS number: 29710-25-6
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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
- Principles of method if other than guideline:
- - Principle of test:
The substance to be tested is applied in a single dose to the skin of an experimental animal. The degree of irritation/corrosion is read and scored at specified intervals and is further described in order to provide a complete evaluation of the effects. The duration of the
study should be sufficient to evaluate the reversibility or irreversibility of the effects observed.
- Short description of test conditions: cumulative test performed in rabbits
- Parameters analysed / observed: skin irritation - 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 material
- Reference substance name:
- Icosanyl propionate
- EC Number:
- 265-839-9
- EC Name:
- Icosanyl propionate
- Cas Number:
- 65591-14-2
- Molecular formula:
- C23H46O2
- IUPAC Name:
- icosyl propionate
- Test material form:
- not specified
- Details on test material:
- - State of aggregation:
no data
- Particle size distribution: no data
- 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 relevant
- Density: no data
- Moisture content: no data
- Residual solvent: no data
- Activation: no data
- Stabilisation: no data
- Other: no data
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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: 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
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): a 10% solution and undiluted test article
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
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): not specified
- Concentration (if solution): not specified
POSITIVE CONTROL
- Amount(s) applied (volume or weight): not specified
- Concentration (if solution): not specified - Duration of treatment / exposure:
- cumulative irritation test
- Observation period:
- not specified
- Number of animals:
- not specified
- Details on study design:
- 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
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) not specified
SCORING SYSTEM:
- Method of calculation: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: skin irritation
- Remarks:
- general considerations
- Basis:
- other: not specified
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- other: no indication of irritation
- Remarks:
- 10% solution was nonirritating
- Irritation parameter:
- other: skin irritation
- Remarks:
- general considerations
- Basis:
- other: not specified
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- other: probability of weak irritation
- Remarks:
- undiluted test article was slightly irritating
- Irritant / corrosive response data:
- not specified
- Other effects:
- not specified
Any other information on results incl. tables
not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A 10% solution was nonirritating and undiluted test article was slightly irritating in a cumulative irritation test.
- Executive summary:
A 10% solution was nonirritating and undiluted test article was slightly irritating in a cumulative irritation test.
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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