Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 417-440-8 | CAS number: 2516-92-9
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- EC Number:
- 417-440-8
- EC Name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- Cas Number:
- 2516-92-9
- Molecular formula:
- C28 H50 N2 O6
- IUPAC Name:
- bis(1-hydroxy-2,2,6,6-tetramethylpiperidin-4-yl) decanedioate
- Details on test material:
- Identification code (lab) = TKA 40075
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0.01, 0.05, 0.1, 0.5 and 1 mg/plate without S9
0.01, 0.05, 0.1, 0.5 and 1 mg/plate with S9 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
Test Material - Acetone (Mallinckrodt); Lot No. 2435 KVGV; exp. date: 8/31/98
Positive Controls - DMSO (Burdick and Jackson); Lot No. 7AN501; exp. date:5/31/97
- Justification for choice of solvent/vehicle:
Based on solubility and the recommendations of D. Maron et al., Mutat. Res., 1981, 88:343-350, acetone was selected as the solvent for use in the bioassay.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: ICR-191 (Terochem Labs.) 2,4,7-Trinitro-9-fluorenone (2,4,7-TNF) (Aldrich Chemical Co.) 2-Aminofluorene (Aldrich Chemical Co.) 2-Aminoanthracene (Aldrich Chemical Company)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 hours
SELECTION AGENT (mutation assays): histidine and biotin
NUMBER OF REPLICATIONS: 3
- Rationale for test conditions:
- guideline test conditions
- Statistics:
- no statistics were applied
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test material GUlO-415 was non-mutagenic in S. typhimurium tester strains TA1535, TA1537, TA1538, TA97a, TA98, and TA100 in the presence or absence of S9 at doses of up to 1 mg/plate.
- Executive summary:
A Salmonella/Microsome assay for bacterial mutagenicity (Ames test) was conducted using test material GU10-415.
The test material was soluble in acetone which was used as a diluent for the bioassay. Six tester strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA97a, TA98, and TA100) were exposed to five levels of the test material with and without the presence of S9. The doses ranged from 0.01 to 1.0 mg/plate with and without the presence of S9. Each assay was conducted in triplicate at each concentration with positive and negative controls. No evidence of mutagenicity (twice background) was observed in any tester strain.
The test material GU10-415 was not mutagenic in any of the six tester strains of Salmonella typhimurium.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
