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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
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 administered by inhalation route to experimental animals. Subsequently, observations of effects (systemic toxicity) and deaths are made
- Short description of test conditions: 1-hour inhalation exposure to formulations of the test substance
- Parameters analysed / observed: mortality and systemic toxicity effects were observed
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: not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl myristate
EC Number:
203-751-4
EC Name:
Isopropyl myristate
Cas Number:
110-27-0
Molecular formula:
C17H34O2
IUPAC Name:
isopropyl myristate
Test material form:
not specified
Details on test material:
- State of aggregation: not specified
- Particle size distribution: not specified
- Mass median aerodynamic diameter (MMAD): not specified
- Geometric standard deviation (GSD): not specified
- Shape of particles: not specified
- Surface area of particles: not specified
- Crystal structure: not specified
- Coating: not specified
- 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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: 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

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: not specified
- Exposure chamber volume: not specified
- Method of holding animals in test chamber: not specified
- Source and rate of air: not specified
- Method of conditioning air: not specified
- System of generating particulates/aerosols: not specified
- Method of particle size determination: not specified
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: not specified

TEST ATMOSPHERE
- Brief description of analytical method used: not specified
- Samples taken from breathing zone: yes/no not specified

VEHICLE
- Composition of vehicle (if applicable): not specified
- Concentration of test material in vehicle (if applicable): not specified
- Justification of choice of vehicle: not specified
- Lot/batch no. (if required): not specified
- Purity: not specified

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not specified
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not specified

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Remarks on duration:
no data
Concentrations:
formulations containing 16%-20% (33-41 mg/L) and 4.7% (9.7 mg/L)
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: deaths or evidence of systemic toxicity
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 33 - <= 41 mg/L air
Based on:
not specified
Exp. duration:
1 h
Remarks on result:
other: formulations containing 16%-20%
Sex:
not specified
Dose descriptor:
LC50
Effect level:
9.7 mg/L air
Based on:
not specified
Exp. duration:
1 h
Remarks on result:
other: formulation containing 4.7%
Mortality:
the substance did not produce any deaths
Clinical signs:
other: the substance did not produce any evidence of systemic toxicity
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
1-hour inhalation exposure to formulations containing 16%-20% (33-41 mg/L) and 4.7% (9.7 mg/L) did not produce any deaths or evidence of systemic toxicity in rats