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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics 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

Objective of study:
other: Hydrolysis
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on exposure:
not specified
Duration and frequency of treatment / exposure:
2 h
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: %
Dose / conc.:
2 other: %
No. of animals per sex per dose:
Rats were fed chow containing 2% cetyl myristoleate or untreated feed
Control animals:
not specified
Positive control:
not specified
Details on study design:
Hydrolysis was evaluated by the presence of cetyl alcohol
Details on dosing and sampling:
not specified
Statistics:
not specified

Results and discussion

Preliminary studies:
not specified

Toxicokinetic / pharmacokinetic studies

Details on absorption:
not specified
Details on distribution in tissues:
not specified
Details on excretion:
not specified

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
no cetyl alcohol was found in the stomach, intestinal content, or intestinal mucosa in either group.

Bioaccessibility

Bioaccessibility testing results:
not specified

Any other information on results incl. tables

not specified

Applicant's summary and conclusion

Conclusions:
Hydrolysis was evaluated by the presence of cetyl alcohol, and no cetyl alcohol was found in the stomach, intestinal content, or intestinal mucosa in either group
Executive summary:

Rats were fed chow containing 2% cetyl myristoleate or untreated feed for 2 hours. Hydrolysis was evaluated by the presence of cetyl alcohol, and no cetyl alcohol was found in the stomach, intestinal content, or intestinal mucosa in either group