Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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

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
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.
Type of assay:
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
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:
mouse
Strain:
not specified
Details on species / strain selection:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Assigned to test groups randomly: 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:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: not specified
- Concentration of test material in vehicle: not specified
- Amount of vehicle (if gavage or dermal): not specified
- Type and concentration of dispersant aid (if powder): not specified
- Lot/batch no. (if required): not specified
- Purity:not specified
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: not specified

DIET PREPARATION
- Rate of preparation of diet (frequency): not specified
- Mixing appropriate amounts with (Type of food): not specified
- Storage temperature of food: not specified
Duration of treatment / exposure:
single dose
Frequency of treatment:
not specified
Post exposure period:
not specified
Doses / concentrationsopen allclose all
Dose / conc.:
500 other: mg/kg
Dose / conc.:
1 500 other: mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Positive control(s):
no data
- Justification for choice of positive control(s): not specified
- Route of administration: not specified
- Doses / concentrations: not specified

Examinations

Tissues and cell types examined:
not specified
Details of tissue and slide preparation:
not specified
Evaluation criteria:
not specified
Statistics:
not specified

Results and discussion

Test results
Key result
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: no clastogenic effect

Applicant's summary and conclusion

Conclusions:
A mixture that also contained stearyl caprylate was not mutagenic in an Ames test with or without metabolic activation and had no clastogenic effect in an in vivo micronucleus test in which mice were given a single oral dose of 500-1500 mg/kg in corn oil
Executive summary:

A mixture that also contained stearyl caprylate was not mutagenic in an Ames test with or without metabolic activation and had no clastogenic effect in an in vivo micronucleus test in which mice were given a single oral dose of 500-1500 mg/kg in corn oil