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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
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 substance to be tested is applied to the eyes of the experimental animal. The degree of eye irritation/corrosion is evaluated by scoring lesions.
- Short description of test conditions: experimental study performed in rabbits exposed to the undiluted test material and a formulation
- Parameters analysed / observed: eye 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
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

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues 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

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
not specified
Duration of treatment / exposure:
not specified
Observation period (in vivo):
not specified
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
not specified
Details on study design:
not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: eye irritation
Remarks:
(general consideration)
Basis:
other: not specified
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Undiluted test material was not irritating to rabbit eyes
Irritation parameter:
other: eye 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:
a formulation containing 7% were not irritating to rabbit eyes
Irritant / corrosive response data:
Undiluted test materiai and a formulation containing 7% were not irritating to rabbit eyes
Other effects:
- Lesions and clinical observations: not specified
- Ophthalmoscopic findings: not specified
- Histopathological findings: not specified
- Effects of rinsing or washing: not specified
- Other observations: not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Undiluted test material and a formulation containing 7% were not irritating to rabbit eyes
Executive summary:

Undiluted test material and a formulation containing 7% were not irritating to rabbit eyes.