Registration Dossier

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:
2015
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

Constituent 1
Reference substance name:
PEG-4 Diheptanoate
Molecular formula:
UVCB
IUPAC Name:
PEG-4 Diheptanoate
Test material form:
liquid

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
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 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
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.