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Toxicological information

Acute Toxicity: dermal

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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:
2015
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
Name:
Unnamed
Type:
Constituent
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
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 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:
no data
Body weight:
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