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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Remarks:
human repeat insult patch tests (HRIPTs)
Type of information:
experimental study
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

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
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

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.

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: not specified
- Sex: not specified
- Age: not specified
- Race: not specified
- Demographic information: not specified
- Other:not specified
Clinical history:
- History of allergy or casuistics for study subject or populations: not specified
- Symptoms, onset and progress of the disease: not specified
- Exposure history: not specified
- Aggravating factors both in home and workplace: not specified
- Family history: not specified
- Medical history (for respiratory hypersensitivity): not specified
- Any other allergic or airway disorders: not specified
- Smoking history: not specified
- Other:not specified
Controls:
not specified
Route of administration:
dermal
Details on study design:
not specified

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: not specified

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: not specified
- Number of subjects with negative reactions: not specified
- Number of subjects with equivocal reactionsnot specified
- Number of subjects with irritating reactionsnot specified

RESULT OF CASE REPORT: not specified

OTHER RESULTS: not specified

Applicant's summary and conclusion

Conclusions:
In human testing, cosmetic formulations were not sensitizers in human repeat insult patch tests (HRIPTs).
Executive summary:

In human testing, cosmetic formulations were not sensitizers in human repeat insult patch tests (HRIPTs).