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EC number: 203-674-6 | CAS number: 109-46-6
- 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)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2011, March 1st to 2011, April 5
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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-diethylthiourea
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle– France)
- Age at study initiation: males = 7 week-old, females = 8 week-old
- Weight at study initiation: males 225-245 g, females 204-228 g
- Fasting period before study:
- Housing: individually, in solid-bottomed clear polycarbonate cages
- Diet (e.g. ad libitum): M20-SDS, ad libitum
- Water (e.g. ad libitum): tap-water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 to 25°C
- Humidity (%):30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- DMSO
- Details on dermal exposure:
- Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item.
Animals from treated group 1 received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of 1,3-Diethyl-2-thiourea (DETU). 4.0 g of the test item was weighed and dimethyl sulfoxide was added to a 20 mL volumetric flask. The preparation was
magnetically stirred to obtain a colorless solution just before the administration. The preparation was administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hours exposure period, the gauze dressings were removed.
Animals from treated group 2 received by topical application, under porous gauze dressing, an effective dose of 1000 mg/kg body weight of 1,3-Diethyl-2-thiourea (DETU). 1.0 g of the test item was weighed and dimethyl sulfoxide was added to a 10 mL volumetric flask. The preparation was
magnetically stirred to obtain a colorless solution just before the administration. The preparation was administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hours exposure period, the gauze dressings were removed. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw for males and females + 1000 mg/kg bw for females
- No. of animals per sex per dose:
- at 2000 mg/kg bw : 5 males and 5 females
at 1000 mg/kg bw: 5 females - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: at D0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes - Statistics:
- no
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality was observed in males treated with 2000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Remarks on result:
- other: All females died with 2000 mg/kg bw but all females survived when they were treated with 1000 mg/kg bw.
- Mortality:
- It was noted the death of 5 female rats treated at 2000 mg/kg b.w. (5/5): 3 rats at 47 hours 50 minutes post-dose and 2 rats at 55 hours 25 minutes post-dose. No mortality occurred during the study in the male treated at the dose of 2000 mg/kg b.w. (0/5) or in the female treated at the dose of 1000 mg/kg b.w. (0/5).
- Clinical signs:
- other: In females treated with 2000 mg/kg bw, the mortalities were preceded 24 hours post dose, by absence or decrease in spontaneous activity (5/5), in Preyer’s reflex (5/5), in body temperature (5/5), in muscle tone (3/5) and in righting reflex (2/3), bradypne
- Gross pathology:
- Females (2000 mg/kg bw) : The macroscopical examination of the dead animals revealed a dark red or bright red coloration of the
lungs (3/5) and an important vascularisation under the treatment area (2/5).
Males (2000 mg/kg bw) and females (1000 mg/kg bw) : The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. - Other findings:
- no
Any other information on results incl. tables
Table 1 / Body weight and weight gain (dose = 2000 mg/kg)
Males |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rm 5838 |
245 |
240 |
-5 |
287 |
42 |
347 |
102 |
Rm 5839 |
232 |
204 |
-28 |
255 |
23 |
319 |
87 |
Rm 5840 |
239 |
213 |
-26 |
269 |
30 |
345 |
106 |
Rm 5841 |
248 |
228 |
-20 |
282 |
374 |
359 |
111 |
Rm 8542 |
225 |
211 |
-14 |
261 |
36 |
322 |
97 |
Mean |
237.8 |
219.2 |
-18.6 |
270.8 |
33.0 |
338.4 |
100.6 |
SD |
9.4 |
14.5 |
9.4 |
13.6 |
7.1 |
17.2 |
9.2 |
Females |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 5843 |
209 |
Died |
/ |
/ |
/ |
/ |
/ |
Rf 5844 |
216 |
190 |
-26 |
Died |
/ |
/ |
/ |
Rf 5902 |
207 |
189 |
-18 |
Died |
/ |
/ |
/ |
Rf 5903 |
204 |
Died |
/ |
/ |
/ |
/ |
/ |
Rf 5904 |
213 |
Died |
/ |
/ |
/ |
/ |
/ |
Mean |
209.8 |
189.5 |
-22.0 |
/ |
/ |
/ |
/ |
SD |
4.8 |
0.7 |
5.7 |
/ |
/ |
/ |
/ |
Table 2 / Body weight and weight gain (dose = 1000 mg/kg)
Females |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 6013 |
213 |
209 |
-4 |
216 |
3 |
229 |
16 |
Rf 6014 |
207 |
188 |
-19 |
210 |
3 |
235 |
28 |
Rf 6159 |
228 |
223 |
-5 |
250 |
22 |
259 |
31 |
Rf 6160 |
216 |
210 |
-6 |
250 |
34 |
272 |
56 |
Rf 6161 |
227 |
218 |
-9 |
249 |
22 |
265 |
38 |
Mean |
218.2 |
209.6 |
-8.6 |
235.0 |
16.8 |
252.0 |
33.8 |
SD |
9.1 |
13.4 |
6.1 |
20.2 |
13.5 |
18.9 |
14.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In conclusion, the LD50 observed of the test item 1,3-Diethyl-2-thiourea (DETU) is equal to 2000 mg/kg body weight by dermal route in the rat.
- Executive summary:
The test item 1,3-Diethyl-2-thiourea (DETU) was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. It is a guideline study (OECD 402) in accordance with GLP principles.
Due to the mortalities observed at the dose of 2000 mg/kg in the 5 females rats, the test item was applied in the same experimental conditions in a group of 5 females (2 in a 1st step and 3 in a second step) at the single dose of 1000 mg/kg body weight.
It was noted the death of 5 female rats treated at 2000 mg/kg b.w. (5/5). The mortalities were preceded 24 hours post dose, by several clinical signs as absence or decrease in spontaneous activity or in Preyer’s reflex. The macroscopical examination of the dead animals revealed a dark red or bright red coloration of the lungs and an important vascularisation under the treatment area.
No mortality occurred during the study in the male treated at the dose of 2000 mg/kg b.w. (0/5) or in the female treated at the dose of 1000 mg/kg b.w. (0/5). No cutaneous reactions related to the administration of the test item were observed.
In the male treated at the dose of 2000 mg/kg b.w. it was observed a decrease in the spontaneous activity (5/5) at 24 hours post dose. The animals recovered a normal activity at 48 hours post dose. In the female treated at the dose of 1000 mg/kg b.w., it was observed several clinical signs as a decrease in the spontaneous activity. The animals recovered a normal activity at 48 or 72 hours post dose. A decrease in the body weight was noted on day 2 in the male treated at 2000 mg/kg b.w. The animals recovered a normal body weight from day 7. The body weight evolution of the female treated at the dose of 1000 mg/kg b.w remained normal throughout the study.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 observed of the test item 1,3-Diethyl-2-thiourea (DETU) is 2000 mg/kg body weight by dermal route in the rat. The LD50 of the test item 1,3-Diethyl-2-thiourea (DETU) is higher than 1000 mg/kg body weight and lower than 2000 mg/kg body weight by dermal route in the female rat. The LD50 of the test item 1,3-Diethyl-2-thiourea (DETU) is higher than 2000 mg/kg body weight by dermal route in the male rat.
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