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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
sensitisation test
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:
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 animals are initially exposed to the test substance by intradermal injections. Following a rest period (induction period), during which an immune response may develop, the animals are exposed to a challenge dose. The extent and degree of skin reaction to the challenge exposure in the test animals is compared with that demonstrated by control animals which undergo sham treatment during induction and receive the challenge exposure.
- Short description of test conditions: test was performed on guinea pig
- Parameters analysed / observed: skin sensitisation
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.
Type of study:
not specified
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
not specified
- Females (if applicable) nulliparous and non-pregnant:
not specified
- Microbiological status of animals, when known:
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
- Indication of any skin lesions:
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

Results and discussion

Positive control results:
not specified

In vitro / in chemico

Other effects / acceptance of results:
not specified

In vivo (non-LLNA)

Results
Key result
Reading:
other: not specified
Group:
other: not specified
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Remarks:
not a sensitizer when injected undiluted test material

In vivo (LLNA)

Cellular proliferation data / Observations:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was judged as not sensitizer when injected intradermally.
Executive summary:

The substance was judged as not sensitizer when injected intradermally.