Registration Dossier
Registration Dossier
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EC number: 249-793-7 | CAS number: 29710-25-6
Genetic toxicity: in vivo
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:
- 2 015
- 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 substance name:
- Octadecyl heptanoate
- EC Number:
- 266-065-4
- EC Name:
- Octadecyl heptanoate
- Cas Number:
- 66009-41-4
- Molecular formula:
- C25H50O2
- IUPAC Name:
- octadecyl heptanoate
- 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
Constituent 1
- 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 or test system 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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