Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Bacterial gene mutation)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
-
EC Number:
444-000-2
EC Name:
-
Cas Number:
Not specified
Molecular formula:
Not applicable because it is a UVCB substance.
IUPAC Name:
3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate; 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
Escherichia coli strain WP2uvrA-.
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Arocolor-induced rat liver S9 fraction
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/ml
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/ml
Vehicle / solvent:
Solvent: Acetone
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 5000 µg/plate

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>5000 µg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>5000 µg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: Test system: preliminary test

Any other information on results incl. tables

Observations:

Vehicle control plates gave counts of revertant colonies within the normal range. All positive control chemicals used in the test induced marked increases in the frequency of revertant colonies with and without activation. The test material caused no visible reduction in the growth of the bacterial lawn at any dose level. The test material was therefore tested up to the maximum recommended dose of 5000 µg/plate. No significant increases in frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material with or without activation.

Applicant's summary and conclusion

Conclusions:
negative with metabolic activation
negative without metabolic activation