Registration Dossier
Registration Dossier
Diss Factsheets
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: 618-939-5 | CAS number: 933999-84-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to O.E.C.D. Testing Guideline 471 with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol
- EC Number:
- 618-939-5
- Cas Number:
- 933999-84-9
- Molecular formula:
- C6H14O2 + C3H5ClO
- IUPAC Name:
- 2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol
- Details on test material:
- As per IUCLID5 Sections 1.1 - 1.4.
Constituent 1
Method
- Target gene:
- histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Strain TA 1538 was also used.
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rrat liver S9 fraction.
- Test concentrations with justification for top dose:
- TA 98 and TA 100 (ug/plate): 1, 3, 10, 33, 100, 333, 1000, 5000
TA 1535, TA 1537, and TA 1538 (ug/plate): 1, 3, 10, 33, 100, 333, 1000, 5000 - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- sodium azide, 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Positive control substance:
- other: 2-Aminoantracene was the positive control for S9 metabolic activation.
- Details on test system and experimental conditions:
- The bacterial tester strains were stored frozen in nutrient broth plus 8% v/v DMSO in liquid nitrogen. Liqiud bacterial cultures were initiated from the frozen stock in 20 mL Nutrient broth in 250 mL Erlenmeyer flasks. Cultures were incubated with shaking at approximately 37 degrees C for 6 hr. The plating medium was 1.5% Vogel-Bonner minimal medium supplemented agar. The sofy overlay medium was minimal medium supplemented with 8.0 gram Difco Bacto and 10.5 mg L-histidine / liter.
The S9 liver fraction was prepared from the livers of 8 - 12 week old male Wistar rats that had been induced with 500 mg/kg Aroclor 1254 by i.p. injection. The livers were harvested and washed in ice cold 150 mM KCL and homogenized. The liver homogenated was diluted 1:3 with ice cold KCL and centrifuged in the cold at 9,000 g for 10 minutes. The resulting S9 fraction was stored frozen at approximately -70 C. The protein content of the S9 fraction was standardized to 20 to 45 mg/mL. The S9 mix was prepared by diluting the S9 fraction 3:7 with S9 cofactors and storing on ice for the study.
For treatment 0.1 mL of test substance solution or control, 0.5 mL of S9 metabolic activation mix or 0.5 mL buffer (no metabolic activation) 0.1 mL bacterial culture and 2 mL overlay soft agar was added and mixed rapidly in pre=warmed test tubes. The contents of the test tubes were then poured over and distributed on the minimal medium plates. All plating were made in triplicate. The plates were incubated for approximately 72 hr at 37 C before scoring. The bacterial colonies were counted by means of a BIOTRAN III counter (BIOTRO-NIK, D-6000 Frankfurt, F.R.G.). The counter ws intrfaced to an Apple II minicomputer for data acquision and calculation. - Evaluation criteria:
- Solvent control background mutant frequcies are within the laboratory accepted range. A test substance is considered to induce a positev mutational response if in strain TA 100 an increse over the concurent control background value is at least 2-fold. In tester strains TA 1535, 1537 1538 and TA 98 the increase over the control background value must be 3-fold. Also, a dose-related increase of the mutant frequency is desirable.
- Statistics:
- No data.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and 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 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- 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:
- with and 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 1537
- Metabolic activation:
- with and 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 and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- 1,6-Hexanediol Diglycidylether (HDDGE) was not cytotoxic in a preliminary assay conducted upto a high dose level of 5.0 mg/plate. Treatment of tester strains TA 1535 and TA 100 with HDDGE resulted in dose-related increase of the mutant frequency in both the presence and absence of rat liver derived S9 metabolic activation perperation. Treatment with HDDGE also induced a dose-related increase of the mutant frequency in strain TA 1538. without S9 metabolic activation. In strain ta 1535 at 5.0 mg/plate the mutant frequency was 26-fold the concurrent control value with S9 metabolic activation and 15-fold without S9 metabolic activation. In tester strain TA 100 the mutant frequency was 12-fold the vehicle control value at 1.0 mg/plate with S9 metabolic avtivation and 9-fold the control background value without S9 metabolic avtivation.
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Test Substance: Grilonit RV 1812 |
|||||
S9 mix from: rat liver (Batch R 270886) |
|||||
Without S9 mix |
Revertants/plate Mean from three plates |
||||
Dose ug/plate |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
0.0 10.0 33.3 100.0 333.3 1000.0 5000.0 |
30 40 45 64 108 210 460 |
14 12 13 20 18 18 28 |
33 31 44 45 61 84 87 |
33 50 54 41 57 14 0 |
129 200 225 497 922 1176 722 |
Positive controls |
|||||
Sodium azide (10 ug/plate) 4-nitro-o-phenylene-diamine (50 ug/plate) |
584 |
257 |
1735 |
1318 |
975 |
With S9 mix |
Revertants/plate Mean from three plates |
||||
Dose ug/plate |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
0.0 10.0 33.3 100.0 333.3 1000.0 5000.0 |
36 39 40 96 260 424 942 |
24 17 20 28 23 23 25 |
35 38 33 39 40 48 50 |
54 50 51 38 47 95 36 |
142 157 193 233 701 1737 1031 |
Positive controls |
|||||
2-amino-anthracene (10ug/plate) |
451 |
464 |
1283 |
1370 |
859 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
It can be stated that during the described mutagenicity test and under the experimental conditions reported, 1,6-Hexanediol Diglycidylether (HDDGE) did induce point mutations by base pair changes (or frameshifts in strain TA 1538) in the genome of the strains used. Therefore, HDDGE is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
1,6-Hexanediol Diglycidylether (HDDGE) was evaluated for mutagenic potential in an O.E.C.D. bacterial mutation 471 Testing Guideline study with GLP compliance. Dose-related increases of the mutant frequency were observed in tester strains TA 1535, TA 1538 and TA 100. HDDGE was mutagenic to strains TA 1535 and TA 100 with and without rat liver derived S9 metabolic activation preperation. Therefore, under the experimental conditions reported, 1,6-Hexanediol Diglycidylether did induce point mutations by base pair changes (or frameshifts in strain TA 1538) in the genome of the strains used and HDDGE is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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.
