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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
- 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
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- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Toxicological Summary
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
An acute oral and dermal toxicity study according to OECD 423 and OECD 402, respectively are available. Both are establishing a LD50 of 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-09 to 2001-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Substance type: organic
- Physical state: colourless solid
- Analytical purity: 100%
- Purity test date: 01 March 2000
- Lot/batch No.: 0232 07
- Expiration date of the lot/batch: March 2003
- Storage condition of test material: store dry in closed containers
- Other: stable at dry storage conditions for at least 2 years - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: Body weight at the commencement of the study: male 150- 168 g and female 142- 160 g. 3 male and 3 female animals were used.
- Fasting period before study: Prior to administration of the test item animals were fasted by withholding food overnight. Following the period of fasting the animals were weighed and the test item was administered. Then the food was withheld for a further 3-4hours.
- Housing: The animals were barrier maintained (semi-barrier) in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): 10x per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg TDI-Urone in 1 % Carboxymethylcellulose (CMC, Sigma, Lot-No. 36H0738) ad 10 ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle:The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): 36H0738
- Purity: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for 14 days after dosing. The animals were weighed prior to first application and once a week thereafter. A careful clinical examination was made twice a day on the day of dosing and once a day thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- As none of the animals died the LD0 is >2000 mg/kg body weight.
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Necropsy revealed an acute injection of blood vessels in all animals in fue abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
- Other findings:
- no other findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of TDI-Urone was established to be > 2000 mg/kg body weight. As none of the animals died the corresponding LD0 is > 2000 mg/kg bw. Thus, TDI-Urone is practically nontoxic.
- Executive summary:
In an acute oral toxicity study according to OECD 423, groups of 3 male and 3 female rats (Wistar) were given a single oral dose of 2000 mg/kg body weight TDI-Urone in 1% Carboxymethylcellulose and were observed for 14 days.
Considering the reported data of this toxicity test it can be stated that the test item TDI-Urone has no acute toxic characteristics.
According to the results obtained the LD50 was determined to be > 2000 mg/kg bw.
Reference
Table1: Bodyweight gain
Animal No. |
Day 0 |
Day 7 |
Day 14 |
|
male |
1 |
150 |
188 |
229 |
2 |
168 |
215 |
256 |
|
3 |
160 |
210 |
240 |
|
female |
1 |
142 |
158 |
170 |
2 |
146 |
159 |
180 |
|
3 |
160 |
169 |
184 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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 - 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
- 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In an acute oral toxicity study according to OECD 423, a limit dose of 2000 mg/kg bw TDI-Urone in 1% Carboxymethylcellulose did not show any signs of toxicity in female and male rats. A LD0 of 2000 mg/kg bw was established.
In an acute dermal toxicity study according to OECD 402 a limit dose of 2000 mg/kg bw TDI-Urone did not show any toxic effects in 5 female and 5 male Wistar rats. 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 practically non-toxic.
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008 LD50-doses of more than 2000 mg/kg are not considered to indicate oral and dermal acute toxicity.
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.
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