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EC number: 943-625-2 | CAS number: -
- 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
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-12-28 to 2011-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- EC Number:
- 241-523-6
- EC Name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- Cas Number:
- 17526-94-2
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Cas Number:
- 17607-23-7
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TDI urone
- Substance type: organic
- Physical state: solid, white powder
- Analytical purity: 97.5 %
- Lot/batch No.: 126815
- Expiration date of the lot/batch: 2013-06-01
- Storage condition of test material: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g +/-20 %
- Fasting period before study: no
- Housing: housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 changes per hours
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10% of the total body surface
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: surgical gauze; piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair was wiped with cotton wool moistened with distilled water to remove any residual test item
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): see below
- Dose applied: 2000 mg/kg bw.
- For solids, paste formed: For the purpose of the study the test item was weighed out according to each animal's individual bodyweight and moistened with distilled water prior to application.
VEHICLE
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): n.a.
- Lot/batch no. (if required): not reported
- Purity: distilled water - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females and five males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to application of the test item on Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,dermal reations - Statistics:
- none
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- no other findings
Any other information on results incl. tables
Table 1: Individual Bodyweights and Weekly Bodyweight Changes
Dose Level mg/kg |
Animal number and sex |
Body weight (g) at day |
Body weight change (g) during week |
|||
2000 |
0 |
7 |
14 |
1 |
2 |
|
1-0 male |
390 |
402 |
419 |
12 |
17 |
|
1-1 male |
365 |
379 |
400 |
14 |
21 |
|
1-2 male |
329 |
351 |
390 |
22 |
39 |
|
1-3 male |
357 |
369 |
381 |
12 |
12 |
|
1-4 male |
330 |
357 |
383 |
27 |
26 |
|
2-0 female |
216 |
220 |
232 |
4 |
12 |
|
2-1 female |
209 |
215 |
217 |
6 |
2 |
|
2-2 female |
200 |
204 |
217 |
4 |
13 |
|
2-3 female |
208 |
213 |
219 |
5 |
6 |
|
2-4 female |
218 |
222 |
228 |
4 |
6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TDI-Urone is considered to be practically nontoxic when dermally applied in a single dose. The LD50 was determined to be > 2000 mg/kg bw. As none of the animals died the LD0 is > 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study groups of 8-12 week old Wistar rats (5 males and 5 females) were dermally exposed to TDI-Urone (97.5%) moistened with water for 24 hours to 10% of the body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
The dermal LD50 (combined) was determined to be > 2000 mg/kg bw. As none of the animals died the LD0 is > 2000 mg/kg bw.
Therefore, TDI-Urone is considered as practically non-toxic when applied dermally in a single dose of 2000 mg/kg bw.
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