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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 922-178-7 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2010-05-17 to 2010-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2010-07-19
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- lce 10038
- IUPAC Name:
- lce 10038
- Details on test material:
- lOT: t93611
CHEMICAL NAME: DISTILLED ACETALIZATION PRODUCTS BETWEEN GLUCOSE AND C12/18 ALCOHOL
CAS numbers: 54549-27-8; 54549-26-7; 27836-65-3; 27836-64-2; 67762-25-8
Container: ^lastic flask
Aspect: white pellets
Storage: room temperature (20 +/- 5°C)
Purity: 100%
Reception: 2010-05-12
Lemi code: DTT 120510
Constituent 1
Method
- Target gene:
- S. typhimurium: histidine
E. coli: tryptophane
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2
- Additional strain / cell type characteristics:
- other: uvrA-; pKM101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sp-mix
- Test concentrations with justification for top dose:
- bacteriostatic assay: maximum 5000ug/Plate tested.
other assay: maximum 1500 mg/plate. (12 / 45 / 150 / 450 / 1500 ug/plate) - Vehicle / solvent:
- Ethanol
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: dimethylbenzanthracene
- Positive controls:
- yes
- Positive control substance:
- other: cis-Platinum
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Details on test system and experimental conditions:
- Assay mithout metabolic activation
Salmonella typhimurium strains: for every strain, 0.1mL of the bacterial suspension containing 1-5 *10^9 bacteria/mL and 0.1 mL of every yest substance concentration are successively added to two mL of overlay agar maintained surfusion in 45°C containing 10%(v/v) of aL-Histidin-D-Biotin solution (0.5 mM).
Escherichia coli strain: in a test tube 0.1 mL of the bacterial suspension containing 1-5*10^9 and 0.1 mLof every test substance concentration are successively added to 2 mL of overlay agar maintained surfusion in 45°C containing 5% (v/v) of nutrient broth n°2 to which are added 5 uL of a L-Tryptophan solution at 2 mg/mL.
Plates are incubated at 37°C over 48-72 hour period. The number of revertant colonies per plate is counted.
Assay with metabolic activation
Two test can be performed using
- either a standard plate incorporation method where the protocol is similar to that described above, except that just before pouring the mixture onto the plates, 500uL of S9-mix fraction is quickly mixed,
- or the pre-incubation assay where the test substance is preincubated with test strain, and 500uL of S9-mix fraction usually for 20 min, or more at 37°C prior to mixing with the averlay agar and pouring onto the surface of the animal agar plate. Tubezs should be aerated during pre-incubation by using a shaker. This method is known to increase the detection sensivity of a number of promutagens like alkaloïds, aliphatic N-nitroso compounds (OECD n°471) - Evaluation criteria:
- R= number of revertant colonies in the presence of the substance/ number of revertant colonies in the absence of the test substance
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2
- 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 1535, TA 1537, TA 98 and TA 100
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance, LCE 10038 lot n°T93611 (LEMI code: DTT 120510), provided by SEPPIC, does not induce any mutagenic change in Salmonella typhimurium TA 1535, 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA) (pKM101), without or with metabolic activation according to the OECD guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC - Executive summary:
The purpose of this procedure is to quantitatively assess the mutagenic effect of a test substance in four Salmonelle typhimurium strains (Ames and al) and one Escherichia coli WP2 (uvrA-) (pKM 101) strain (Matsuchima and al), in compiance with the OECD guidelines 471 for the testing of chemicals.
The assay is performed using five concentrations of the test substance, in both the presence and absence of an appropriate metabolic activation system (rat liver microsome fraction).
Concentrations tested: 12 / 45 / 150 / 450 / 1500 ug/plate
The test substance, LCE 10038 lot n°T93611 (LEMI code: DTT 120510), provided by SEPPIC, does not induce any mutagenic change in Salmonella typhimurium TA 1535, 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA) (pKM101), without or with metabolic activation according to the OECD guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC
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.
