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EC number: 203-308-5 | CAS number: 105-55-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- DNA fragmentation and DNA repair synthesis induced in rat and human thyroid cells by chemicals carcinogenic to the rat thyroid.
- Author:
- Mattioli F, Martelli A, Gosmar M, Garbero C, Manfredi V, Varaldo E, Torre GC, Brambilla G.
- Year:
- 2 006
- Bibliographic source:
- Mutation Research 609, 146-153
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- DETU was assayed for the ability to induce DNA damage in primary cultures of human thyroid cells : DNA fragmentation was evaluated by the Comet assay.
- GLP compliance:
- no
- Type of assay:
- comet assay
Test material
- Reference substance name:
- 1,3-diethyl-2-thiourea
- EC Number:
- 203-308-5
- EC Name:
- 1,3-diethyl-2-thiourea
- Cas Number:
- 105-55-5
- Molecular formula:
- C5H12N2S
- IUPAC Name:
- 1,3-diethyl-2-thiourea
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: human thyroid cells
- Details on mammalian cell type (if applicable):
- Samples of human thyroid were obtained from discarded surgical material during the course of prescribed surgery. Informed consent was obtained from each subject, and before signing the patient was told that a fragment of his thyroid wouldbe used for a scientific research. Donors 1, 5, 8, 11 and 12 were males, ranging from 49- to 68-year old; donors 2, 3, 4, 6, 7, 9,10 and 13 were females, ranging from 49- to 74-year old; all under went surgery for simple multinodular goiter. The simple multinodular goiter do not cause hormonal dysfunction.The tissue sample was obtained from areas in which haemorrhage,fatty degeneration, and fibrosis were absent. Thyroid cells wer eisolated as previously described within 2 h from thyroidectomy. The percentage of viable cells, as measured by the trypan blue exclusion test, ranged from 90 to 95%. Morphologically, the cells appeared to be more than 90% follicular cells; theother cells were mainly fibroblasts.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 1.25, 2.5 and 5.0 mM
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: 75µM
- Details on test system and experimental conditions:
- PRIMARY CULTURES:
Aliquots of cell suspensions were plated in 24-well uncoated TC plates (2 x 10^5cells per 14.5 mm well) for the Comet assay, and in 35-mm dishes coated with rat tail collagen (1 x 10^6cells per dish) for determination of cytotoxicity and DNA repair synthesis. After an attachment period of 3 hat 37 °C in an atmosphere of 95% air- 5% C02, cell cultureswere washed and incubated for 20h with serial concentrations of the test compounds and the positive control methyl methenesulfonate (MMS) in serum-free medium. In these short-term assays, exposure of cultures to test compounds for 16-20h is recommended; shorter exposure times might be inappropriate, and a longer exposure results in a reduction of cellmetabolic competence and of cell viability. The media containing methimazole and potassium bromate were freshly preparedfrom stock solutions in distilled water and the media containingethylenethiourea fromstock solutions in dimethyl sulfoxide; the maximum dimethylsulfoxide concentration (0.5%) was present in correspondingcontrol cultures. MMS was directely dissolved in the mediumjust prier to use, [Methyl-3H]thymidine (10 µCi/ml) was addedto thyroid cell cultures to be used for the DNA repair assay andleft in the culture for the entire treatment period. At the end oftreatment, cells were immediately examined for cytotoxicityby trypan blue exclusion, for DNA fragmentation by the Cometassay, and for DNA repair synthesis by quantitative autoradiography. Compound was assessed for DNA damage and repair in three independent experiments using cultures from three different donors. - Statistics:
- Statistical analysis of data was performed by the use of ANOVA andthe two samples compared were values of tail length and tail moment in 50 cells from each dose point. The p <0.05 level was considered to be statistically significant.
Results and discussion
Test results
- Key result
- Species / strain:
- other: human thyroid cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The DNA damaging concentrations ranged from 1.25 and 5 MM for DETU.
Results show that in three independent experiments on cells from three different donors a statistically significant dose-dependent increase of both tail length and tail moment, indicative of DNA single-strand breaks and/or alkali-labile sites was consistently produced by a 20h-exposure ti subtoxic concentrations of DETU.
Any other information on results incl. tables
Table of results: Damage of nuclear DNA induced in primary cultures of human thyroid cells by a 20h-exposure to DETU
Treatment conditions |
Donor no. |
Relative survival |
Comet assay |
|
Tail length (µm) |
Tail moment |
|||
Solvent control (DMSO) |
8 (M, 49) |
(0.94) |
2.4+/-0.6 |
186+/-51 |
DETU 1.25 mM |
0.98 |
2.8+/-0.6 a |
239+/-49 a |
|
DETU 2.5 mM |
0.94 |
3.6+/-1.6ª |
274+/-85a |
|
DETU 5 mM |
0.90 |
3.7+/-1.9a |
288+/-129a |
|
MMS 75 mM |
0.98 |
27.2+/-2.5a |
2211+/-286a |
|
Solvent control (DMSO) |
9 (F, 49) |
(0.94) |
2.0+/-0.4 |
204+/-35 |
DETU 1.25 mM |
1.02 |
3.0+/-2.7a |
305+/-216 a |
|
DETU 2.5 mM |
1.01 |
4.1+/-2.5a |
342+/-227a |
|
DETU 5 mM |
0.86 |
4.6+/-3.9a |
358+/-307a |
|
MMS 75 mM |
1.00 |
22.2+/-8.1a |
1998+/-724a |
|
Solvent control (DMSO) |
10 (F, 74) |
(0.96) |
1.9+/-0.4 |
171+/-31 |
DETU 1.25 mM |
0.99 |
2.6+/-1.2a |
238+/-110 a |
|
DETU 2.5 mM |
0.97 |
2.7+/-0.9a |
260+/-87a |
|
DETU 5 mM |
0.98 |
2.8+/-1.0a |
267+/-95a |
|
MMS 75 mM |
0.98 |
19.5+/-6.8a |
1766+/-530a |
a = comet assay, significance level was determined by use of ANOVA (p<0.05)
Applicant's summary and conclusion
- Conclusions:
- DETU induced in primary cultures of human thyroid cells a significant dose-dependent increase in the tail length.
- Executive summary:
DETU was assayed for the ability to induce DNA damage a in primary cultures of human thyroid cells : DNA framentation/Comet assay was performed. Cells were exposed at 1.25, 2.5 and 5.0 mM of DETU.
Results show that in three independent experiments on cells from three different donors a statistically significant dose-dependent increase of both tail length and tail moment, indicative of DNA single-strand breaks and/or alkali-labile sites was consistently produced by a 20h-exposure ti subtoxic concentrations of DETU.
DETU induce in primary cultures of human thyroid cells a significant dose-dependent increase in the frequency of the tail length.
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