Registration Dossier
Registration Dossier
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EC number: 701-435-5 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Liponate 2-DH CIR Report April 7, 2015
- Author:
- Cosmetic Ingredient Review
- Year:
- 2 015
- Bibliographic source:
- CIR Report April 7, 2015
Safety Assessment of PEG Diesters as Used in Cosmetics
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- - Principle of test:
OECD 471 method with independent repeat.
Reference found in the CIR report. The study is part of EPA HPV program. - GLP compliance:
- not specified
- Remarks:
- Principle of test: OECD 471 method with independent repeat. Reference found in the CIR report. The study is part of EPA HPV program.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- PEG-4 Diheptanoate
- Molecular formula:
- UVCB
- IUPAC Name:
- PEG-4 Diheptanoate
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 500-10 000 microg/plate
100-2500 microg/plate - Vehicle / solvent:
- none
Controls
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Bacterial Reverse mutation assay using S. typhimurium strains TA98, TA100, TA1535 and TA1537 is negative with and without metabolic activation.
PEG-4 Diheptanoate is not considered as mutagenic.
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