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Diss Factsheets
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EC number: 204-781-0 | CAS number: 126-30-7
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 may 2016 - 25 aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diol
- EC Number:
- 204-781-0
- EC Name:
- 2,2-dimethylpropane-1,3-diol
- Cas Number:
- 126-30-7
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 76582139K0
- Expiration date of the lot/batch: 17 Jan 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test substance under storage conditions was guaranteed by the sponsor
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix (phenobarbital- and beta-naphthoflavone induced rats)
- Test concentrations with justification for top dose:
- 1st Experiment
without S9 mix
0; 34.4; 68.8; 137.5; 275.0; 550.0; 1100.0 μg/mL
with S9 mix
0; 34.4; 68.8; 137.5; 275.0; 550.0; 1100.0 μg/mL
2nd Experiment
without S9 mix
0; 43.8; 87.5; 175.0; 350.0; 700.0; 1100.0 μg/mL
with S9 mix
0; 43.8; 87.5; 175.0; 350.0; 700.0; 1100.0 μg/mL - Vehicle / solvent:
- Due to the good solubility of the test substance in water, culture medium (Ham's F12) was selected as most suitable vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
Time schedule
Day 1: Seeding of the cells pretreated with "HAT" medium: in 300 cm² flasks
Day 2: Test substance incubation (approx. 20 – 24 hours after seeding); exposure
period (4 hours); removal of test substance by intense washing;
1st passage of the treated cells in 175 cm2 flasks and seeding of the cloning efficiency 1 (survival) in
60 mm petri dishes.
Day 5: 2nd passage of the treated cells
Day 7 - 9: Drying, fixation, staining and counting of the cloning efficiency 1
3rd passage of the treated cells; addition of selection medium ("TG" medium)
and seeding of the cloning efficiency 2 (viability) in 60 mm petri dishes
From day 16: Drying, fixation, staining and counting of the selected colonies and the cloning efficiency 2
In this study, all incubations were performed at 37°C with a relative humidity of ≥ 90% in a
5% (v/v) CO2 atmosphere.
SELECTION AGENT : 6-thioguanine
STAIN: Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: about 200 cells per concentration
CRITERIA FOR MICRONUCLEUS IDENTIFICATION:
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
- OTHER: pH, Osmolality; Solubility; Cell morphology - Evaluation criteria:
- A test substance is considered to be clearly positive if all following criteria are met:
A statistically significant increase in mutant frequencies is obtained.
A dose-related increase in mutant frequencies is observed.
The corrected mutation frequencies (MFcorr.) exceeds both the concurrent negative/vehicle
control value and the range of our laboratory’s historical negative control data (95% control limit)
Isolated increases of mutant frequencies above our historical negative control range or isolated
statistically significant increases without a dose-response relationship may indicate a biological
effect but are not regarded as sufficient evidence of mutagenicity.
A test substance is considered to be clearly negative if the following criteria are met:
Neither a statistically significant nor dose-related increase in the corrected mutation
frequencies is observed under any experimental condition.
The corrected mutation frequencies in all treated test groups is close to the concurrent
vehicle control value and within the range of our laboratory’s historical negative control data
(95% control limit) - Statistics:
- An appropriate statistical trend test (MS EXCEL function RGP) was performed to assess a
possible dose-related increase of mutant frequencies. The used model is one of the proposed
models of the International Workshop on Genotoxicity Test procedures Workgroup Report .
The dependent variable was the corrected mutant frequency and the independent variable was
the concentration. The trend was judged as statistically significant whenever the one-sided
p-value (probability value) was below 0.05 and the slope was greater than 0.
In addition, a pair-wise comparison of each test group with the vehicle control group was carried
out using one-sided Fisher's exact test with Bonferroni-Holm correction. The calculation
was performed using R.
If the results of these tests were statistically significant compared with the respective vehicle
control, labels (s p ≤ 0.05) are printed in the tables.
However, both, biological and statistical significance are considered together.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Thus, in the absence and the presence of metabolic activation, Neopentylglycol is not a mutagenic substance
in the HPRT locus assay using CHO cells under the experimental conditions chosen.
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