Registration Dossier
Registration Dossier
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EC number: 947-344-6 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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 ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
[Describe why the read-across can be performed (e.g. common functional group(s), common precursor(s)/breakdown product(s) or common mechanism(s) of action]
Substance tested : Ethylhexyl Laurate (C12 esters) analogous to Tridecyl palmitate (C16 esters) and Tridecyl Stearate (C18 esters)
2. ANALOGUE APPROACH JUSTIFICATION
[Summarise here based on available experimental data how these results verify that the read-across is justified]
Tridecyl Palmiate and Tridecyl stearate have longer Carbon chain and we assume that they penetrate less the skin. So the analogous is a good indicator to suspect the behavior of our substance.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Remarks:
- Ethylhexyl Laurate
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- - Principle of test:
Ames test
- Short description of test conditions: Ethylhexyl Laurate is tested at doses 8, 40, 200, 1000 and 5000 microg/plate - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: not specified
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Key result
- Species / strain:
- S. typhimurium, other: not specified
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Ethylhexyl Laurate is not mutagenic in an Ames test performed in S. typhimurium (strains not specified) with and without metabolic activation.
Tridecyl Stearate and TRidecyl Palmitate with longer Carbon chain can be assumed to be non genotoxic.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
Mouse Micronucleus test
- Short description of test conditions: male and female mice were dosed by gavage with 0, 1.25, 2.5 and 5.0 mL/Kg ethylhexyl laurate. the animals were killed after 4, 48 or 72 hours. - GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-ethylhexyl laurate
- EC Number:
- 243-697-9
- EC Name:
- 2-ethylhexyl laurate
- Cas Number:
- 20292-08-4
- Molecular formula:
- C20H40O2
- IUPAC Name:
- 2-ethylhexyl laurate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Doses / concentrations
- Dose / conc.:
- 5 mg/kg bw/day
- Control animals:
- not specified
- Positive control(s):
- not specified
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Ethylhexyl Laurate is not genotoxic in this assay.
Tridecyl Stearate and TRidecyl Palmitate with longer Carbon chain can be assumed to be non genotoxic.
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