2-ethylhexyl 12-hydroxyoctadecanoate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Remarks:

Derma/ Penetration

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

Type of study / information:

observations in humans exposed to a chemical substance

Endpoint addressed:

dermal absorption

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

Ethical approval:

not specified

Exposure assessment:

measured

Details on exposure:

TYPE OF EXPOSURE: direct application of the substance on the ventral forearm of 14 humans

TYPE OF EXPOSURE MEASUREMENT: 7 μL/cm2 was applied neat to a 2 x 8 cm2 site

EXPOSURE LEVELS: 7 μL/cm2 was applied neat to a 2 x 8 cm2 site

EXPOSURE PERIOD: 3 h

POSTEXPOSURE PERIOD: The test site was tape-stripped 3 hours after application, and attenuated tota! reflectance-Fourier transform infrared spectra
measurements were determined

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: not specified

Results and discussion

Results:

The researchers stated the most of the isostearyl isostearate was located at the surface ofthe stratum corneum. The percentage recovery ofthe amount applied was not specified.

Applicant's summary and conclusion

Conclusions:

The researchers stated the most of the isostearyl isostearate was located at the surface ofthe stratum corneum. The percentage recovery ofthe amount applied was not specified.

Executive summary:

Predeuterated isostearyl isostearate, 7 μL/cm2, was applied neat to a 2 x 8 cm2 site on the ventral forearm of 14 humans for 3 hours under nonocclusive conditions. The test site was tape-stripped 3 hours after application, and attenuated tota! reflectance-Fourier transform infrared spectra measurements were determined. The researchers stated the most of the isostearyl isostearate was located at the surface

of the stratum corneum. The percentage recovery ofthe amount applied was not specified.